StemCell Therapy

Second Product Candidate Expected to Enter Clinic in First Half of 2021

Preclinical Data Underscore Treatment Potential for PBFT02 in Frontotemporal Dementia with Granulin (GRN) Mutations, a Devastating, Progressive Disorder Impacting Adults with No Approved Disease-Modifying Therapy Options

PHILADELPHIA, Jan. 28, 2021 (GLOBE NEWSWIRE) -- Passage Bio, Inc. (Nasdaq: PASG), a genetic medicines company focused on developing transformative therapies for rare, monogenic central nervous system (CNS) disorders, today announced that the U.S. Food and Drug Administration (FDA) has cleared an investigational new drug (IND) application for PBFT02, an adeno-associated virus (AAV)-delivery gene therapy that is being studied for the treatment of patients with Frontotemporal Dementia (FTD) with granulin (GRN) mutations. FTD is a debilitating form of early onset dementia that currently has no approved disease-modifying therapies.

We are pleased to be advancing our second therapy into clinical development in our quest to bring transformative medicines to patients who need them, said Bruce Goldsmith, Ph.D., chief executive officer of Passage Bio. FTD can have a devastating impact on a persons quality of life and create a substantial caregiving and economic burden for families. We are excited to investigate the potential of PBFT02 as a treatment for FTD-GRN as we initiate our clinical development program in the coming months.

FTD is one of the more common causes of early-onset (midlife) dementia, causing impairment in behavior, language and executive function, and occurs at similar frequency to Alzheimers disease in patients younger than 65 years. In approximately 5 to 10 percent of individuals with FTD 3,000 to 6,000 in the United States the disease occurs because of mutations in the GRN gene, causing a deficiency of progranulin (PGRN). PGRN is a complex and highly conserved protein. The mechanism by which PGRN deficiency results in FTD is uncertain, but increasing evidence points to PGRNs role in lysosomal function. The rapid progression of FTD results in an average survival of eight years after onset of symptoms.

Passage Bio is developing PBFT02 to treat FTD-GRN as a single dose delivered via intra-cisterna magna (ICM) injection. The gene therapy utilizes an AAV1 viral vector to deliver a modified DNA encoding the GRN gene to a patient's cells. The goal of this vector and delivery approach is to provide higher than normal levels of PGRN to the central nervous system to overcome the progranulin deficiency in GRN mutation carriers, who have been observed to have reduced cerebrospinal fluid PGRN levels ranging from 30% to 50% of the PGRN levels observed in normal, mutation non-carriers.

Clinical Development of PBFT02 Supported by University of Pennsylvanias Gene Therapy Program (GTP) Pre-Clinical Data

Passage Bio is advancing PBFT02 into the clinic supported by preclinical data generated by its collaborator, University of Pennsylvanias Gene Therapy Program (GTP). The data, published in the peer-reviewed scientific journal Annals of Clinical and Translational Neurology, showed that a single administration of an optimized AAV containing the GRN gene resulted in elevated levels of PGRN in the brain and cerebral spinal fluid (CSF), reduced lysosomal storage lesions, normalized lysosomal enzyme expression and corrected microgliosis in a mouse model of progranulin deficiency. A single administration of PBFT02 via the optimized AAV1-GRN vector demonstrated transduction broadly across the brain, including a very high transduction of ependymal cells that line the ventricles of the brain and are involved with CSF production, resulting in CSF progranulin levels of more than 50-fold normal.

The FDA has granted an Orphan Drug designation for PBFT02 for the treatment of FTD-GRN.

Phase 1/2 Study Initiation Anticipated for 1H21

Passage Bio expects to initiate a Phase1/2 clinical trial for PBFT02 in the first half of 2021. The trial is designed as a dose-escalation study of a single ICM dose of PBFT02 in subjects with FTD and heterozygous mutations in the GRN gene. The primary endpoint of the Phase 1/2 study is safety and tolerability; secondary endpoints include CSF progranulin levels, disease biomarkers, and clinical outcome measure. Initial data from the trial is anticipated to potentially readout in late 2021 or early 2022, depending on the timing of when the first patient is treated in the study.

About Passage Bio

At Passage Bio (Nasdaq: PASG), we are on a mission to provide life-transforming gene therapies for patients with rare, monogenic CNS diseases that replace their suffering with boundless possibility, all while building lasting relationships with the communities we serve. Based in Philadelphia, PA, our company has established a strategic collaboration and licensing agreement with the renowned University of Pennsylvanias Gene Therapy Program to conduct our discovery and IND-enabling preclinical work. This provides our team with access to a broad portfolio of gene therapy candidates and future gene therapy innovations that we then pair with our deep clinical, regulatory, manufacturing and commercial expertise to rapidly advance our robust pipeline of optimized gene therapies into clinical testing. As we work with speed and tenacity, we are always mindful of patients who may be able to benefit from our therapies. More information is available at http://www.passagebio.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of, and made pursuant to the safe harbor provisions of, the Private Securities Litigation Reform Act of 1995, including, but not limited to: our expectations about timing and execution of anticipated milestones, including our planned IND submissions, initiation of clinical trials and the availability of clinical data from such trials; our expectations about our collaborators and partners ability to execute key initiatives; our expectations about manufacturing plans and strategies; our expectations about cash runway; and the ability of our lead product candidates to treat the underlying causes of their respective target monogenic CNS disorders. These forward-looking statements may be accompanied by such words as aim, anticipate, believe, could, estimate, expect, forecast, goal, intend, may, might, plan, potential, possible, will, would, and other words and terms of similar meaning. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements, including: our ability to develop and obtain regulatory approval for our product candidates; the timing and results of preclinical studies and clinical trials; risks associated with clinical trials, including our ability to adequately manage clinical activities, unexpected concerns that may arise from additional data or analysis obtained during clinical trials, regulatory authorities may require additional information or further studies, or may fail to approve or may delay approval of our drug candidates; the occurrence of adverse safety events; the risk that positive results in a preclinical study or clinical trial may not be replicated in subsequent trials or success in early stage clinical trials may not be predictive of results in later stage clinical trials; failure to protect and enforce our intellectual property, and other proprietary rights; our dependence on collaborators and other third parties for the development and manufacture of product candidates and other aspects of our business, which are outside of our full control; risks associated with current and potential delays, work stoppages, or supply chain disruptions caused by the coronavirus pandemic; and the other risks and uncertainties that are described in the Risk Factors section in documents the company files from time to time with the Securities and Exchange Commission (SEC), and other reports as filed with the SEC. Passage Bio undertakes no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.

For further information, please contact:

Passage Bio Investors:

Sarah McCabe and Zofia MitaStern Investor Relations, Inc.212-362-1200sarah.mccabe@sternir.com Zofia.mita@sternir.com

Passage Bio Media:

Gwen FisherPassage Bio215-407-1548gfisher@passagebio.com

Excerpt from:
Passage Bio Receives FDA Clearance of IND Application for PBFT02 Gene Therapy Candidate for Treatment of Patients with Frontotemporal Dementia with...

REDWOOD CITY, Calif., Feb. 02, 2021 (GLOBE NEWSWIRE) -- Adverum Biotechnologies, Inc. (Nasdaq: ADVM), a clinical-stage gene therapy company targeting unmet medical needs in ocular and rare diseases, today announced the publication of preclinical data on ADVM-022 intravitreal (IVT) gene therapy in Translational Vision Science & Technology (TVST), an official journal of the Association for Research in Vision and Ophthalmology (ARVO). ADVM-022 is in clinical trials for wet AMD and DME, and this preclinical study in NHPs is the longest safety and expression study to date, with measurements out 30 months following a single IVT injection.

There is a growing body of both clinical and preclinical data demonstrating durable efficacy and favorable safety profile following a single IVT injection of ADVM-022, said Laurent Fischer, M.D., chief executive officer at Adverum Biotechnologies. In this preclinical study, we saw long-term, sustained aflibercept expression out to 30 months following ADVM-022. The levels of aflibercept were sustained at therapeutic levels, with no measurable adverse effects on normal retinal structure and function. We are excited to work on developing ADVM-022 as a potential one and done IVT injection therapy that may dramatically reduce the treatment burden for patients living with wet AMD and DME.

Szilrd Kiss, M.D., academic retina specialist, added, Currently, patients with wet AMD are treated with frequent anti-VEGF intravitreal injections to maintain their vision. One of the highest priorities in research today is to develop therapies that extend the duration of efficacy following treatment, enabling patients to preserve sight for months or years following treatment. The preclinical data on ADVM-022 demonstrate long-term safety and aflibercept expression following a single intravitreal injection of this novel IVT injection gene therapy. We are excited to continue to assess ADVM-022 as it demonstrates the potential to improve real-world visual outcomes over intermittent anti-VEGF injections for patients living with wet AMD.

The publication, titled Long-Term Safety Evaluation of Continuous Intraocular Delivery of Aflibercept by the Intravitreal Gene Therapy Candidate ADVM-022 in Nonhuman Primates, reported the following:

The full online publication can be accessed from the TVST website.

About ADVM-022 Gene TherapyADVM-022 utilizes a propriety vector capsid, AAV.7m8, carrying an aflibercept coding sequence under the control of a proprietary expression cassette. ADVM-022 is administered as a one-time intravitreal injection (IVT), designed to deliver long-term efficacy and reduce the burden of frequent anti-VEGF injections, optimize patient compliance and improve vision outcomes for patients with wet age-related macular degeneration (wet AMD) and diabetic macular edema (DME).

In recognition of the need for new treatment options for wet AMD, the U.S. Food and Drug Administration granted Fast Track designation for ADVM-022 for the treatment of wet AMD.

Adverum is currently evaluating ADVM-022 in the OPTIC Phase 1 clinical trial in patients with wet AMD and the INFINITY Phase 2 trial in patients with DME at 2 x 10^11 vg/eye and 6 x 10^11 vg/eye doses. The Company plans to begin a pivotal trial in mid-2021 for ADVM-022 in wet AMD.

About Adverum BiotechnologiesAdverum Biotechnologies (Nasdaq: ADVM) is a clinical-stage gene therapy company targeting unmet medical needs in serious ocular and rare diseases. Adverum is advancing the clinical development of its novel gene therapy candidate, ADVM-022, as a one-time, intravitreal injection for the treatment of patients with wet age-related macular degeneration and diabetic macular edema. For more information, please visit http://www.adverum.com.

Forward-looking StatementsStatements contained in this press release regarding the events or results that may occur in the future are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include but are not limited to statements regarding: the potential for ADVM-022 in treating patients with wet AMD and DME; the potential efficacy and safety of ADVM-022 in wet AMD and DME; Adverums expectations as to its plans to advance ADVM-022 in wet AMD by initiating a pivotal trial mid-2021. Actual results could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include risks inherent to, without limitation: Adverums novel technology, which makes it difficult to predict the time and cost of product candidate development and obtaining regulatory approval; the results of early clinical trials not always being predictive of future results; the potential for future complications or side effects in connection with use of ADVM-022. Risks and uncertainties facing Adverum are described more fully in Adverums Form 10-Q filed with theSEConNovember 5, 2020under the heading Risk Factors. All forward-looking statements contained in this press release speak only as of the date on which they were made. Adverum undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

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Adverum Biotechnologies Announces Publication of Preclinical Long-Term Safety Data on ADVM-022 IVT Gene Therapy - GlobeNewswire

Undaunted by the challenges the COVID-19 pandemic unleashed on the world the expected surge of cell and gene therapies already in the pipeline and on the horizon will continue to materialize, and with them the complexity of riding that wave of innovation.

Just two years ago the U.S. Food and Drug Administration (FDA) forecast that it would be flooded by 2020 with about 200 Investigational New Drugs a year on top of the more than 800 active cell-based or gene therapies it was already processing. The agency projected that by 2025 it would be approving anywhere between 10 to 20 new cell and gene therapy products a year. By 2024, the FDA and the pharmaceutical and biopharmaceutical industries expect more than 40 new and innovative cell and gene therapies will be available on the market.

Although the pandemic disrupted drug discovery and development efforts early in the crisis, the industry has been quick to respond and adjust. The CG&T market will likely slow from $6.68 billion in 2019 to $6.92 in 2020 because of the pandemic, yet it is forecast to recover and grow to an estimated $13.23 billion by 2023, according to Researchandmarkets.com.

There is more momentum than ever before to bring these innovative medicines to market, said Doug Cook, president of Commercialization Services and Animal Health at AmerisourceBergen. The influx of therapies offers tremendous promise and hope to patients with conditions where there are few treatment options and no cures. But these complex products introduce new considerations throughout the commercialization journey, so its critical that manufacturers work with a partner that can help them navigate challenges at each stepfrom pre-clinical and commercial logistics to market access strategies and patient support solutions.

Because CG&T are derived from a patients own cells, time and temperature have become critical factors from the moment they are extracted on through the manufacturing process and then returned as a curative life-saving therapy. As such, there is little room for failure or delay throughout the supply chain.

Given the narrow window of viability of these therapies they need to be shipped as quickly as possible to preserve the time the cells are active. With such a constraint on the time those cells are viable, the pressure on logistics providers has become even more acute. Clearly, supply chain companies that have larger networks and better access to more depots are more advantageous for manufacturers, but more importantly, for patients.

The complexity of these treatments can be staggering both from a development perspective and on into storage and transportation, Cook said. For the first time, the patient is now part of the supply chain where they used to be at the end of it, and thats really different than anything weve seen before.

Many, if not most, of CG&T require ultra-frozen storage from the development stage on through to the application to the patient. This is an element of the supply chain the public is becoming acutely aware of as a result of the COVID-19 pandemic. For example: Pfizer-BioNTechs COVID-19 vaccine must be stored in containers that can achieve between -80 to -60 degrees Celsius. C> require storage conditions from ultracold (-80 degrees Celsius) down to cryogenic temperatures (-135 to -150 degrees Celsius). To ensure the product remains viable throughout transport, the shipping containers must have the ability to keep a constant monitor of the temperatures as well as have real-time GPS tracking.

The shorter the shelf life of the cell therapy, the more intense the logistical challenges. To achieve successful outcomes in what are very patient-centric treatmentsoften referred to as a vein-to-vein supply chainrequires manufacturers to partner with experienced and technologically advanced wholesalers and distributors that have a global reach and ability to address issues with customs and country-specific regulatory requirements.

As the wave of these therapies begins to swell past the approval stage, the need for infrastructure that can handle CG&T has to be in place to avoid bottlenecks and delays that could limit patient access.

Because of all the complexity, handoffs are where mistakes happen, and you need a partner who focuses on all those small details and makes the process seamless, Cook said. This is where experience matters, and capabilities are essential.

In order to continue to meet and exceed its capabilities, early last year AmerisourceBergen strengthened its logistics offerings by integrating its global logistics provider, World Courier, with ICS, its third-party (3PL) provider. Now fully integrated, the service offers a complete cryogenic supply chain. World Courier and ICS offer vapor-charged cryogenic storage with fully automated technology and temperature-controlled transport from a manufacturers location to a storage facility and then to each point of care in dry shipment containers. The group has extensive experience in navigating international borders while maintaining temperature requirements.

With a global network of more than 140 offices, World Couriers has the ability to provide cryogenic shipping solutions that are close to patient and manufacturing locations, which provides much more flexibility as well as cutting response times for patient and hospital needs.

Its become clear as we navigated through COVID that everything has to be connected in ways they werent before, Cook said. As a result, weve invested in more technology services to better position ourselves to support CG&T and play the role of partner and connector more than ever before.

And we are always looking at ways to offer more cohesive capabilities.

To learn more about how AmerisourceBergen anticipates supply and demand and how we do business and the role of distributors in the supply chain check out:https://www.amerisourcebergen.com/pharmaceutical-distribution/value-of-the-distributor

Continued here:
Meeting the commercialization challenge of a surging gene and cell therapy market - FierceBiotech

NEW YORK, Feb. 3, 2021 /PRNewswire/ -- Aruvant Sciences, a private company focused on developing gene therapies for rare diseases,today announced that the European Medicines Agency (EMA) granted Priority Medicines (PRIME) designation to ARU-1801, a one-time investigational gene therapy for sickle cell disease (SCD).

"PRIME designation from EMAhighlightsthe importance of ARU-1801, administeredwith only reduced intensity conditioning,for the treatment ofindividuals with severe sickle cell disease,"said Will Chou, M.D., Aruvant chief executiveofficer."With PRIME,we will be able to work closely with EMAon the development of ARU-1801, with the goal of rapidlybringingthispotential cure toSCD patients in Europe."

PRIME was created by the European Medicines Agency (EMA) to enhance support for the development of innovative medicinesthat target an unmet medical needand demonstratethe potential to achieve relevant clinical outcomes on morbidity, mortality or underlying disease progression. The PRIME designation offersenhanced early interaction with companiesdeveloping promising medicines, to optimize development plans and speed up evaluation. PRIME focuses on medicines that may offer a major therapeutic advantage over existing treatments, or that benefit patients without treatment options.

ARU-1801 was designated PRIME status based on clinical data from the MOMENTUMstudy, an ongoing Phase 1/2 trial of ARU-1801 in patients with severe sickle cell disease, that demonstrate meaningful,durable reductions in disease burden.

About ARU-1801ARU-1801 is designed to address the limitations of current curative treatment options, such as low donor availability and the risk of graft-versus-host disease (GvHD) seen with allogeneic stem cell transplants. Unlike investigational gene therapies and gene editing approaches which require fully myeloablative conditioning, the unique characteristics of ARU-1801 allow it to be given with reduced intensity conditioning ("RIC"). Compared to myeloablative approaches, the lower dose chemotherapy regimen underlying RIC has the potential to reduce not only hospital length of stay, but also the risk of short- and long-term adverse events such as infection and infertility. Preliminary clinical data from the MOMENTUMstudy, an ongoing Phase 1/2 trial of ARU-1801 in patients with severe sickle cell disease, demonstrate continuing durable reductions in disease burden.

The MOMENTUM StudyAruvant is conducting the MOMENTUM study, which is evaluating ARU-1801, a one-time potentially curative investigational gene therapy for patients with SCD. This Phase 1/2 study is currently enrolling participants, and information may be found at http://www.momentumtrials.comwhich includes a patient brochure, an eligibility questionnaireand information for healthcare providers.

About Aruvant SciencesAruvant Sciences, part of the Roivant family of companies, is a clinical-stage biopharmaceutical company focused on developing and commercializing gene therapies for the treatment of rare diseases. The company has a talentedteamwith extensive experience in the development, manufacturing and commercialization of gene therapy products. Aruvant has an activeresearchprogram with a lead product candidate, ARU-1801, in development for individuals suffering fromsickle cell disease(SCD). ARU-1801, an investigational lentiviral gene therapy, is being studied in aPhase 1/2 clinical trial,the MOMENTUM study, as a one-time potentially curative treatment for SCD. Preliminary clinical data demonstrate engraftment of ARU-1801 and amelioration of SCD is possible with one dose of reduced intensity chemotherapy. For more information on the clinical study, please visit http://www.momentumtrials.comand for more on the company, please visitwww.aruvant.com. Follow Aruvant on Facebook, Twitter @AruvantSciencesand on Instagram @Aruvant_Sciences.

About RoivantRoivant's mission is to improve the delivery of healthcare to patients by treating every inefficiency as an opportunity. Roivant develops transformative medicines faster by building technologies and developing talent in creative ways, leveraging the Roivant platform to launch Vants nimble and focused biopharmaceutical and health technology companies. For more information, please visit http://www.roivant.com.

SOURCE Aruvant Sciences

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Aruvant Announces the European Medicines Agency (EMA) Granted Priority Medicines (PRIME) Designation to ARU-1801 for the Treatment of Sickle Cell...

NEW YORK, Feb. 1, 2021 /PRNewswire/ --Welsh, Carson, Anderson & Stowe ("WCAS"), a leading private equity firm focused exclusively on the healthcare and technology industries, announced today that it is committing up to $250 million to a strategic partnership with Kiniciti, a newly-formed platform. Kiniciti will invest in non-therapeutic companies supporting cell and gene therapy ("CGT") innovation which have the potential to transform the cell and gene therapy ecosystem and deliver the promise of CGT to impact patients' lives.

Principal focus areas for investment include companies with: transformational capabilities in cell engineering and gene-editing; cell sources and other value-added starting materials; process science and scale-up tools and services; production technologies; and, source-to-patient delivery. Kiniciti plans to invest in a cross section of CGT opportunities, large and small, across multiple geographies.

Core to Kiniciti's strategy is its flexible investment model focused on ensuring that the ecosystem of companies supporting cell and gene therapeutics customers have access to the capital and strategic resources necessary to enable these advanced therapies to rapidly and reliably reach patients.This will include control, growth equity and significant minority stake structures intended to:

Kiniciti's leadership team includes Geoffrey Glass, Chief Executive Officer, and Jason Conner, Chief Strategy Officer. For more than 25 years, Mr. Glass has helped lead services and therapeutic companies in the life sciences sector. Mr. Conner has helped numerous high-growth life sciences and services companies in his senior strategy, corporate development, and legal roles over more than two decades. Kiniciti's core team has a total of five decades of experience in growing and scaling companies across the healthcare services, life sciences and tools and equipment sectors organically and through M&A.

Mr. Glass said, "The number of innovations, new companies and clinical trials in the cell and gene therapy space is at an all-time high and, ironically, this is exactly when challenges emerge. The pace of funding and therapeutic innovation is far outstripping the available human capital to design, execute and scale the uniquely demanding processes required by advanced therapies. Furthermore, many promising cell and gene therapy solutions providers lack the scale and capital to support this pace of industry growth. We aim to address these challenges."

"In forming Kiniciti, we are thrilled to partner with WCAS, a pioneer in the private equity industry with a 40-year track record of building strong, sustainable platforms working hand-in-hand with management teams," added Mr. Glass. "The firm has deep experience investing in high growth healthcare businesses that are at unique inflection points. WCAS has raised and successfully managed funds totaling over $27 billion of committed capital, and dozens of public healthcare companies can trace their roots to WCAS. We are pleased that two of WCAS's General Partners, Nick O'Leary and Brian Regan, will serve on our Board of Directors and we look forward to benefitting from their judgment and years of experience."

Nick O'Leary, General Partner at WCAS, said, "Partnering with Kiniciti to help realize the promise of cell and gene therapy represents a natural extension for WCAS's Healthcare franchise. We will pursue opportunities where operational improvements, organic growth initiatives and strategic acquisitions can unlock full potential, for both our investments and the patients these companies serve. In today's cell and gene therapy landscape, we believe that there are many exciting therapy innovators that possess the right science but need the supporting ecosystem essential to advancing their therapeutics at the pace they require and deserve. We look forward to working with the Kiniciti team to help address these critical pain points to help deliver CGT at scale and lower cost."

About KinicitiNewly-formed Kiniciti was established to partner with companies with the potential to transform and strengthen the cell and gene therapy ecosystem. With a highly tailored, collaborative and flexible investment and strategic support model, Kiniciti aims to ensure the promise of cell and gene therapeutics is delivered quickly and safely to patients in need worldwide. The company's leadership team includes professionals experienced in investing in and building successful companies across the life sciences sector. For more information, visit kiniciti.com.

About Welsh, Carson, Anderson & StoweWCAS is a leading U.S. private equity firm focused on two target industries: technology and healthcare. Since its founding in 1979, the firm's strategy has been to partner with outstanding management teams and build value for its investors through a combination of operational improvements, growth initiatives and strategic acquisitions. The firm has raised and managed funds totaling over $27 billion of committed capital. WCAS is currently investing an equity fund, Welsh, Carson, Anderson and Stowe XIII, L.P., which closed on $4.3 billion in commitments in 2019. For more information, please visit wcas.com.

Media and Investment Opportunity Contact:

Geoffrey Glass+1 (212) 650-4104[emailprotected]

SOURCE Welsh, Carson, Anderson & Stowe; Kiniciti

https://www.wcas.com/

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Welsh, Carson, Anderson & Stowe Commits $250 Million in a Strategic Partnership with Kiniciti, a Newly-Formed Platform Investing in Cell and Gene...

A Cambridge UK-Korea joint venture promising great things in nextgen cell and gene therapy technology has been rewarded with major cash backing in a Series A round.

Avactas JV with Daewoong Pharmaceutical AffyXell Therapeutics has secured $7.3 million to further develop its pipeline of next generation cell and gene therapies.

AffyXell was established in January 2020 to develop novel mesenchymal stem cell therapies. The business is combining Avactas Affimer platform with Daewoongs MSC platform such that the stem cells are genetically modified to produce and secrete therapeutic Affimer proteins in situ in the patient.

The Affimer proteins are designed to enhance the therapeutic effects of the MSC creating a novel, next generation cell therapy platform.

The Series A funding has been raised from a group of venture funds including Samsung Venture Investment Corporation, Shinhan Venture Investment, Smilegate Investment, Shinhan Investment Corporation, Kolon Investment, Stonebridge Ventures and Gyeongnam Venture Investment.

The proceeds will be used by AffyXell to further the development of MSCs engineered to produce Affimer molecules generated by Avacta that suppress immune response and restore immune balance.

While initially focusing on inflammatory and autoimmune diseases and prevention of organ transplant rejection, longer term goals could also include applications in regenerative medicine, infectious diseases and oncology.

Avacta's R & D costs associated with the generation of the Affimer proteins are funded by AffyXell whilst Avacta retains the rights to commercialise the Affimer proteins outside the field of cell therapies.

Avacta CEO Dr Alastair Smith said: The potential for AffyXells new class of MSC therapies to deliver improved treatments for a wide range of inflammatory and autoimmune diseases is significant, in a market estimated to be worth $16 billionn by 2025.

We expect these novel engineered MSCs to show a more powerful therapeutic effect than existing antibodies and stem cells and they therefore have the potential to lead the rapidly growing field of cell and gene therapy.

AffyXell is uniquely positioned to develop novel and powerful cell therapies through the combination of two world-class technologies: Avactas Affimer platform and Daewoongs proprietary technology for generating off-the-shelf allogeneic MSC therapies.

Completion of the Series A funding is a strong validation of this concept and moves us closer to providing these new therapies to the patients who need them.

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Avacta JV raises $7.3m for cell and gene therapy push | Business Weekly - Business Weekly

Feb. 1, 2021 12:00 UTC

Expects Phase 1/2 biomarker and preliminary clinical data for TSHA-101 in GM2 gangliosidosis in second half of 2021 and by year-end 2021, respectively

Plans to initiate a U.S. Phase 1/2 trial for TSHA-101 in GM2 gangliosidosis in second half of 2021 as well as Phase 1/2 trials for TSHA-118 in CLN1, TSHA-102 in Rett syndrome and TSHA-104 in SURF1-associated Leigh syndrome by year-end 2021

Anticipates advancement of four programs into IND/CTA-enabling studies: SLC13A5 haploinsufficiency, Adult Polyglycosan Body Deficiency (APBD), Lafora disease and GM2 AB variant

Expects IND/CTA submission from one of the following programs: SLC13A5 haploinsufficiency, APBD, Lafora disease, GM2 AB variant and SLC6A1 haploinsufficiency

Anticipates advancement of four new undisclosed programs into preclinical development focused on neurodevelopmental disorders, genetic epilepsies and neurodegenerative diseases

Intends to advance the development of next-generation technologies including miRARE platform, redosing strategy, mini-gene payloads and novel capsids, to optimize key components of the companys AAV-based gene therapies

Continues to make progress on internal 187,000 square-foot, 2,000-liter capacity, multi-product cGMP facility located in Durham, NC

DALLAS--(BUSINESS WIRE)-- Taysha Gene Therapies, Inc. (Nasdaq: TSHA) (Taysha), a patient-centric, clinical-stage gene therapy company focused on developing and commercializing AAV-based gene therapies for the treatment of monogenic diseases of the central nervous system (CNS) in both rare and large patient populations, today highlighted its strategic priorities and provided a business outlook for 2021.

We enter 2021 having built a strong foundation on which to execute our corporate and pipeline objectives. Notably, we expanded our seasoned leadership team and esteemed board of directors steeped in gene therapy development and commercialization expertise, successfully raised funds in our initial public offering, transitioned from a preclinical- to a clinical-stage company, and achieved important progress on R&D initiatives and our three-pillar manufacturing strategy, said RA Session II, President, Founder and CEO of Taysha. 2021 will be a transformational year as we intend to rapidly advance multiple drug candidates to clinical proof-of-concept, further expand our platform-enabled pipeline and advance next-generation technologies. Specifically, we expect to report clinical data for our GM2 gangliosidosis program in the second half of this year and have multiple ongoing clinical studies by year end. We also anticipate several IND/CTA submissions across three CNS franchises and have multiple therapies in IND/CTA-enabling studies while advancing four new programs into preclinical development. In addition, we are excited to advance our next-generation platform technologies and further our efforts in redosing, transgene regulation and capsid development. We believe that our platform will drive future sustained innovation and value creation and look forward to highlighting the productivity of our platform in an R&D day later this year. Lastly, we continue to make progress on cGMP facility and process development capabilities with the completion of the design phase and initiation of procurement of long lead equipment.

Anticipated Milestones by Program

TSHA-101 for infantile GM2 gangliosidosis: the first bicistronic gene therapy in clinical development designed to deliver two genes HEXA and HEXB intrathecally for the treatment of infantile GM2 gangliosidosis, also called Tay-Sachs or Sandhoff disease

TSHA-118 in CLN1: a self-complementary AAV9 viral vector designed to express a human codon-optimized CLN1 transgene to potentially treat CLN1, a rapidly progressing rare lysosomal storage disease with no approved treatments

TSHA-102 in Rett syndrome: a self-complementary AAV9 gene therapy in development for one of the most common genetic causes of severe intellectual disability, designed to deliver MECP2 as well as a novel miRARE platform that regulates transgene expression on a cell-by-cell basis

TSHA-104 in SURF1-associated Leigh syndrome: a self-complementary AAV9 viral vector with a codon optimized transgene encoding the human SURF1 protein to potentially treat SURF1-associated Leigh syndrome, a monogenic mitochondrial disorder with no approved treatments

Pipeline programs advancing into IND/CTA-enabling studies

Discovery programs

Next-generation technology platform

Anticipated Corporate Milestones in 2021

About Taysha Gene Therapies

Taysha Gene Therapies (Nasdaq: TSHA) is on a mission to eradicate monogenic CNS disease. With a singular focus on developing curative medicines, we aim to rapidly translate our treatments from bench to bedside. We have combined our teams proven experience in gene therapy drug development and commercialization with the world-class UT Southwestern Gene Therapy Program to build an extensive, AAV gene therapy pipeline focused on both rare and large-market indications. Together, we leverage our fully integrated platforman engine for potential new cureswith a goal of dramatically improving patients lives. More information is available at http://www.tayshagtx.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as anticipates, believes, expects, intends, projects, and future or similar expressions are intended to identify forward-looking statements. Forward-looking statements include statements concerning or implying the potential of our product candidates to positively impact quality of life and alter the course of disease in the patients we seek to treat, our research, development and regulatory plans for our product candidates and early-stage programs, the potential for these product candidates to receive regulatory approval from the FDA or equivalent foreign regulatory agencies, and whether, if approved, these product candidates will be successfully distributed and marketed, our corporate growth plans and our plans to establish a commercial-scale cGMP manufacturing facility to provide preclinical, clinical and commercial supply. Forward-looking statements are based on managements current expectations and are subject to various risks and uncertainties that could cause actual results to differ materially and adversely from those expressed or implied by such forward-looking statements. Accordingly, these forward-looking statements do not constitute guarantees of future performance, and you are cautioned not to place undue reliance on these forward-looking statements. Risks regarding our business are described in detail in our Securities and Exchange Commission (SEC) filings, including in our Quarterly Report on Form 10-Q for the quarter ended September 30, 2020, which is available on the SECs website at http://www.sec.gov. Additional information will be made available in other filings that we make from time to time with the SEC. Such risks may be amplified by the impacts of the COVID-19 pandemic. These forward-looking statements speak only as of the date hereof, and we disclaim any obligation to update these statements except as may be required by law.

View source version on businesswire.com: https://www.businesswire.com/news/home/20210201005298/en/

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Taysha Gene Therapies Highlights Strategic Priorities and Provides 2021 Business Outlook - BioSpace

Ground zero for disruptive growth in the healthcare sector is genomics through the ARK Genomic Revolution Multi-Sector Fund (CBOE: ARKG).

ARKG holds equity securities of companies across multiple sectors, including health care, information technology, materials, energy, and consumer discretionary, that are relevant to the funds genomics theme. The active management team behind the ARKG strategy combines a top-down and bottom-up research methodology to identify innovative companies and convergence across markets.

The second generation of cell and gene therapy is one of multiple frontiers ARKG provides exposure to. Its also lacking in many old-school biotechnology ETFs.

New cell and gene therapy innovations could increase the total addressable market for oncology therapeutics by more than 20-fold, according to ARK Research.

The actively managed ARKG offers investors a thematic multi-capitalization exposure to innovative elements that cover advancements in gene therapy bio-informatics, bio-inspired computing, molecular medicine, and pharmaceutical innovations.

ARKG includes companies that merge healthcare with technology and capitalize on the revolution in genomic sequencing. These companies try to better understand how biological information is collected, processed, and applied by reducing guesswork and enhancing precision.

Interestingly, ARKG marries one disruptive technology with others.

The US Food and Drug Administration (FDA) approved Gleevec, an oral chemotherapy, after ten years of trials, seven years of which were in solid tumors. This timeline suggests that the FDA could approve the first CAR-T therapy for solid tumors in 2025, notes ARK. Because of artificial intelligence (AI), gene-editing, and next generation sequencing (NGS), failure rates and time-to-market should fall, accelerating approval rates.

The evolution of gene therapies from ex vivo to in vivo is another scenario worth monitoring in the coming years.

Unlike ex vivo, in vivo therapies cannot check edited cells before transduction. That said, in vivo gene therapy is more cost effective and easier to manufacture and scale. It also enables more access to the liver, eye, central nervous system (CNS), and muscles, concludes ARK.

For more on disruptive technologies, visit our Disruptive Technology Channel.

The opinions and forecasts expressed herein are solely those of Tom Lydon, and may not actually come to pass. Information on this site should not be used or construed as an offer to sell, a solicitation of an offer to buy, or a recommendation for any product.

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Unlock the Long-Term Genomics Runway with 'ARKG' - ETF Trends

PHOENIX, Feb. 1, 2021 /PRNewswire/ --(OTC CELZ) Creative Medical Technology Holdings, Inc. announced today new data demonstrating that administration of ImmCelz to animals with a variety of conditions results is a significant surge of the protein hepatocyte growth factor (HGF-1). When scientists blocked the effects of HGF in ImmCelz treated animals, the therapeutic effects where significantly inhibited. The data suggests one of the molecular mechanisms of action of ImmCelz is mediated by production of this therapeutic molecule.

"One of the drawbacks of many cellular therapies is their complicated, and many times ill-defined mechanisms of action." Said Dr. Amit Patel, co-founder of the company and co-inventor of the patent application. "I am proud of our scientific team for focusing not only on the exploration of therapeutic benefits of ImmCelz in a wide variety of diseases, but also on homing in on mechanisms of action. We have previously reported ImmCelz induces T regulatory cells and endogenous neurogenesis.1 The current data suggests that HGF-1 may be acting upstream of these effects."

To date the Company has reported therapeutic activity of ImmCelz in models of rheumatoid arthritis,2 stroke,3 type 1 diabetes,4 kidney failure5 and liver failure.6 The data disclosed today are supported by independent studies which have shown HGF-1 is capable of inducing T regulatory cells7,8 and stimulating neurogenesis.9,10

"Cellular immunotherapy has commanded extremely lucrative valuations for companies in early stages of clinical trials." Said Timothy Warbington, President and CEO of Creative Medical Technology Holdings. "We believe for regenerative immunotherapy products such as ImmCelz to attract similar valuations, understanding of biological mechanisms of action is important. I commend our scientific collaborators for their work that resulted in this current patent filing."

About Creative Medical Technology HoldingsCreative Medical Technology Holdings, Inc. is a commercial stage biotechnology company specializing in regenerative medicine/stem cell technology in the fields of immunotherapy, urology, neurology and orthopedics and is listed on the OTC under the ticker symbol CELZ. For further information about the company, please visitwww.creativemedicaltechnology.com.

Forward Looking StatementsOTC Markets has not reviewed and does not accept responsibility for the adequacy or accuracy of this release. This news release may contain forward-looking statements including but not limited to comments regarding the timing and content of upcoming clinical trials and laboratory results, marketing efforts, funding, etc. Forward-looking statements address future events and conditions and, therefore, involve inherent risks and uncertainties. Actual results may differ materially from those currently anticipated in such statements. See the periodic and other reports filed by Creative Medical Technology Holdings, Inc. with the Securities and Exchange Commission and available on the Commission's website atwww.sec.gov.

Creativemedicaltechnology.comwww.StemSpine.com http://www.Caverstem.com http://www.Femcelz.com ImmCelz.com

1 Creative Medical Technology Holdings Identifies Mechanism of Action of ImmCelz Stroke Regenerative Activity (prnewswire.com)2 Creative Medical Technology Holdings Reports Positive Preclinical Data on ImmCelz Immunotherapy Product in Rheumatoid Arthritis Model | BioSpace3 Creative Medical Technology Holdings Identifies Mechanism of Action of ImmCelz Stroke Regenerative Activity (prnewswire.com)4 Creative Medical Technology Holdings Announces Positive Data and Patent Filing Using ImmCelz to Treat Type 1 Diabetes (prnewswire.com)5 Creative Medical Technology Holdings Files Patent based on Positive Data on Renal Failure using ImmCelz Regenerative Immunotherapy (prnewswire.com)6 Creative Medical Technology Holdings Announces Reversion of Liver Failure Using ImmCelz Personalized Cellular Immunotherapy in Preclinical Model | Nasdaq7 https://pubmed.ncbi.nlm.nih.gov/22158517/ 8 https://pubmed.ncbi.nlm.nih.gov/20332205/ 9 https://pubmed.ncbi.nlm.nih.gov/21683144/ 10 https://pubmed.ncbi.nlm.nih.gov/20963849/

SOURCE Creative Medical Technology Holdings, Inc.

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Creative Medical Technology Holdings Identifies and Files Patent on Novel Mechanism of ImmCelz Therapeutic Activity - PRNewswire

Human lung cells (blue) infected with SARS-CoV-2 (red). Courtesy of Hekman, et al. Credit: Courtesy of Hekman, et al.

Multipronged BU research team finds 18 FDA-approved drugs that could halt coronavirus infection earlier.

What if scientists knew exactly what impact the SARS-CoV-2 virus had inside our lung cells, within the first few hours of being infected? Could they use that information to find drugs that would disrupt the virus replication process before it ever gets fully underway? The discovery that several existing FDA-approved drugsincluding some originally designed to fight cancercan stop coronavirus in its tracks indicates the answer is a resounding yes.

A team of Boston University researchershailing from BUs National Emerging Infectious Diseases Laboratories (NEIDL), the Center for Regenerative Medicine (CReM) at BUs Medical Campus, and BUs Center for Network Systems Biology (CNSB)embarked on a months-long, collaborative and interdisciplinary quest, combining multiple areas of expertise in virology, stem cellderived lung tissue engineering, and deep molecular sequencing to begin answering those questions. They simultaneously infected tens of thousands of human lung cells with the SARS-CoV-2 virus, and then tracked precisely what happens in all of those cells during the first few moments after infection. As if that was not complicated enough, the team had to cool their entire high-containment research facility inside the NEIDL to a brisk 61 degrees Fahrenheit.

The result of that challenging and massive undertaking? The BU team has revealed the most comprehensive map to date of all the molecular activities that are triggered inside lung cells at the onset of coronavirus infection. They also discovered there are at least 18 existing, FDA-approved drugs that could potentially be repurposed to combat COVID-19 infections shortly after a person becomes infected. Experimentally, five of those drugs reduced coronavirus spread in human lung cells by more than 90 percent. Their findings were recently published in Molecular Cell.

Now, academic and industry collaborators from around the world are in contact with the team about next steps to move their findings from bench to bedside, the researchers say. (Although COVID-19 vaccines are starting to be rolled out, its expected to take the better part of a year for enough people to be vaccinated to create herd immunity. And there are no guarantees that the current vaccine formulations will be as effective against future SARS-CoV-2 strains that could emerge over time.) More effective and well-timed therapeutic interventions could help reduce the overall number of deaths related to COVID-19 infections.

What makes this research unusual is that we looked at very early time points [of infection], at just one hour after the virus infects lung cells. It was scary to see that the virus already starts to damage the cells so early during infection, says Elke Mhlberger, one of the studys senior investigators and a virologist at BUs NEIDL. She typically works with some of the worlds most lethal viruses like Ebola and Marburg.

The most striking aspect is how many molecular pathways are impacted by the virus, says Andrew Emili, another of the studys senior investigators, and the director of BUs CNSB, which specializes in proteomics and deep sequencing of molecular interactions. The virus does wholesale remodeling of the lung cellsits amazing the degree to which the virus commandeers the cells it infects.

Viruses cant replicate themselves because they lack the molecular machinery for manufacturing proteinsthats why they rely on infecting cells to hijack the cells internal machinery and use it to spread their own genetic material. When SARS-CoV-2 takes over, it completely changes the cells metabolic processes, Emili says, and even damages the cells nuclear membranes within three to six hours after infection, which the team found surprising. In contrast, cells infected with the deadly Ebola virus dont show any obvious structural changes at these early time points of infection, and even at late stages of infection, the nuclear membrane is still intact, Mhlberger says.

The nuclear membrane surrounds the nucleus, which holds the majority of a cells genetic information and controls and regulates normal cellular functions. With the cell nucleus compromised by SARS-CoV-2, things rapidly take a bad turn for the entire cell. Under siege, the cellswhich normally play a role in maintaining the essential gas exchange of oxygen and carbon dioxide that occurs when we breathedie. As the cells die, they also emit distress signals that boost inflammation, triggering a cascade of biological activity that speeds up cell death and can eventually lead to pneumonia, acute respiratory distress, and lung failure.

I couldnt have predicted a lot of these pathways, most of them were news to me, says Andrew Wilson, one of the studys senior authors, a CReM scientist, and a pulmonologist at Boston Medical Center (BMC), BUs teaching hospital. At BMC, Bostons safety net hospital, Wilson has been on the front lines of the COVID-19 pandemic since March 2020, trying to treat and save the sickest patients in the hospitals ICU. Thats why our [experimental] model is so valuable.

Science is the answerif we use science to ask the lung cells what goes wrong when they are infected with coronavirus, the cells will tell us. Darrell Kotton

The team leveraged the CReMs organoid expertise to grow human lung air sac cells, the type of cell that lines the inside of lungs. Air sac cells are usually difficult to grow and maintain in traditional culture and difficult to extract directly from patients for research purposes. Thats why much coronavirus research to date by other labs has relied on the use of more readily available cell types, like kidney cells from monkeys. The problem with that is kidney cells from monkeys dont react the same way to coronavirus infection as lung cells from humans do, making them a poor model for studying the viruswhatever is learned from them doesnt easily translate into clinically relevant findings for treating human patients.

Our organoids, developed by our CReM faculty, are engineered from stem cellstheyre not identical to the living, breathing cells inside our bodies, but they are the closest thing to it, says Darrell Kotton, one of the studys senior authors. He is a director of the CReM and a pulmonologist at BMC, where he has worked alongside Wilson in the ICU treating COVID-19 patients. The two of them often collaborated with Mhlberger, Emili, and other members of their research team via Zoom calls that they managed to join during brief moments of calm in the ICU.

In another recent study using the CReMs engineered human lung cells, the research team confirmed that existing drugs remdesivir and camostat are effective in combating the virus, though neither is a perfect fix for controlling the inflammation that COVID-19 causes. Remdesivir, a broad-use antiviral, has already been used clinically in coronavirus patients. But based on the new studys findings that the virus does serious damage to cells within hours, setting off inflammation, the researchers say theres likely not much that antiviral drugs like remdesivir can do once an infection has advanced to the point where someone would need to be put on a ventilator in the ICU. [Giving remdesivir] cant save lives if the disease has already progressed, Emili says.

Seeing how masterfully SARS-CoV-2 commandeers human cells and subverts them to do the manufacturing work of replicating the viral genome, it reminded the researchers of another deadly invader.

I was surprised that there are so many similarities between cancer cells and SARS-CoV-2-infected cells, Mhlberger says. The team screened a number of cancer drugs as part of their study and found that several of them are able to block SARS-CoV-2 from multiplying. Like viruses, cancer cells want to replicate their own genomes, dividing over and over again. To do that, they need to produce a lot of pyrimidine, a basic building block for genetic material. Interrupting the production of pyrimidineusing a cancer drug designed for that purposealso blocks the SARS-CoV-2 genome from being built. But Mhlberger cautions that cancer drugs typically have a lot of side effects. Do we really want to use that heavy stuff against a virus? she says. More studies will be needed to weigh the pros and cons of such an approach.

The findings of their latest study took the four senior investigators and scientists, postdoctoral fellows, and graduate students from their laboratories almost four months, working nearly around the clock, to complete the research. Of critical importance to the teams leaders was making sure that the experimental setup had rock-solid foundations in mimicking whats actually happening when the SARS-CoV-2 virus infects people.

Science is the answerif we use science to ask the lung cells what goes wrong when they are infected with coronavirus, the cells will tell us, Kotton says. Objective scientific data gives us hints at what to do and has lessons to teach us. It can reveal a path out of this pandemic.

Hes particularly excited about the outreach the team has received from collaborators around the world. People with expertise in supercomputers and machine learning are excited about using those tools and the datasets from our publication to identify the most promising drug targets [for treating COVID-19], he says.

Kotton says the theme thats become obvious among COVID-19 clinicians and scientists is understanding that timing is key. Once a patient is on a ventilator in the ICU, we feel limited in what we can do for their body, he says. Timing is everything, its crucial to identify early windows of opportunity for intervention. You can keep guessing and hope we get luckyor you [do the research] to actually understand the infection from its inception, and take the guesswork out of drug development.

Reference: Actionable Cytopathogenic Host Responses of Human Alveolar Type 2 Cells to SARS-CoV-2 by Ryan M. Hekman, Adam J. Hume, Raghuveera Kumar Goel, Kristine M. Abo, Jessie Huang, Benjamin C. Blum, Rhiannon B. Werder, Ellen L. Suder, Indranil Paul, Sadhna Phanse, Ahmed Youssef, Konstantinos D. Alysandratos, Dzmitry Padhorny, Sandeep Ojha, Alexandra Mora-Martin, Dmitry Kretov, Peter E.A. Ash, Mamta Verma, Jian Zhao, J.J. Patten, Carlos Villacorta-Martin, Dante Bolzan, Carlos Perea-Resa, Esther Bullitt, Anne Hinds, Andrew Tilston-Lunel, Xaralabos Varelas, Shaghayegh Farhangmehr Ulrich Braunschweig, Julian H. Kwan, Mark McComb, Avik Basu, Mohsan Saeed, Valentina Perissi, Eric J. Burks, Matthew D. Layne, John H. Connor, Robert Davey, Ji-Xin Cheng, Benjamin L. Wolozin, Benjamin J. Blencowe, Stefan Wuchty, Shawn M. Lyons, Dima Kozakov, Daniel Cifuentes, Michael Blower, Darrell N. Kotton, Andrew A. Wilson, Elke Mhlberger and Andrew Emili, 18 November 2020, Molecular Cell.DOI: 10.1016/j.molcel.2020.11.028

This research was funded by the National Institutes of Health, the Australian National Health and Medical Research Council, the Pulmonary Fibrosis Foundation, the Massachusetts Consortium on Pathogen Readiness, the C3.ai Digital Transformation Institute, the Canadian Institutes of Health Research, and Fast Grants.

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How Coronavirus Damages Lung Cells Within Mere Hours And What Drugs Could Halt COVID-19 Infection - SciTechDaily

BIO-TECHNE Corp (TECH) is around the top of the Biotechnology industry according to InvestorsObserver. TECH received an overall rating of 59, which means that it scores higher than 59 percent of all stocks. BIO-TECHNE Corp also achieved a score of 69 in the Biotechnology industry, putting it above 69 percent of Biotechnology stocks. Biotechnology is ranked 24 out of the 148 industries.

Finding the best stocks can be tricky. It isnt easy to compare companies across industries. Even companies that have relatively similar businesses can be tricky to compare sometimes. InvestorsObservers tools allow a top-down approach that lets you pick a metric, find the top sector and industry and then find the top stocks in that sector.

These rankings allows you to easily compare stocks and view what the strengths and weaknesses are of a given company. This lets you find the stocks with the best short and long term growth prospects in a matter of seconds. The combined score incorporates technical and fundamental analysis in order to give a comprehensive overview of a stocks performance. Investors who then want to focus on analysts rankings or valuations are able to see the separate scores for each section.

BIO-TECHNE Corp (TECH) stock is lower by -2.31% while the S&P 500 is higher by 0.47% as of 2:18 PM on Wednesday, Feb 3. TECH is lower by -$8.71 from the previous closing price of $376.76 on volume of 132,763 shares. Over the past year the S&P 500 is higher by 16.58% while TECH is higher by 76.63%. TECH earned $6.28 a per share in the over the last 12 months, giving it a price-to-earnings ratio of 58.64.

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Is BIO-TECHNE Corp (TECH) the Top Pick in the Biotechnology Industry? - InvestorsObserver

Johnson County Community College is a great place for students to begin their educational journey and discover unique career paths. For example, introductory science courses at JCCC open the door to opportunities in specialized fields likebiotechnology.

Introducing a High-Demand Career Path

The field of biotechnology brings us so many amazing innovations in medicine, agriculture and animal health, says Heather Seitz, Professor of Biotechnology at JCCC. Its amazing learning about all the products that have been developed like recombinant insulin for diabetics, human growth hormone used to treat lots of growth disorders, crops that are drought-resistant and new vaccine technologies.

JCCCsIntroduction to Biotechnologydives into career exploration, history and applications of technology, molecular biology and bioethics. This course allows students to develop biotechnology skills while researching and developing an actual biotech product.

Students will learn how to create a product and then they will be able to develop, test and package the product for use by other courses on campus, says Seitz. Its an exciting opportunity for an aspiring biotechnologist.

A Culture of Success

As the field of biotechnology continues to grow, Seitz wants to spread the word to students considering a career in medicine.

I see tons of students who want to cure diseases and we need people working in the labs and helping to test and develop new strategies, she says. This work is really what cures diseases but its not something people often say when asked what they want to be when they grow up. I would argue that they just dont know the name of this important career.

Students can enter the biotechnology industry after earning an associate degree. Common careers include manufacturing technician, cell culture technician, instrument calibration technician, clinical research associate, clinical research administrator and medical laboratory assistant.

Location is Key

Kansas City is home to the Animal Health Corridor, the largest collection of animal health biotechnology companies in the world. In total, there are over 300 biotech companies in the Kansas City metro area, making JCCC an ideal location for this field of study.

Students seeking a bachelors degree in biotechnology wont have to look far. JCCCs courses transfer seamlessly to theUniversity of Kansas Edwards Campus biotechnology program. A bachelors degree allows students to work for companies that manufacture vaccines, develop new diagnostic tests and create personalized medicines and other products.

Randy Logan, Director of KUs biotechnology program, tells students that each class they take before their transfer is an important one.

The classes you take in your freshman and sophomore year lay the foundation for your downstream coursework, he said. You will build on that foundation and expand in complex and exciting ways. Focus on mastering the content you are given and never treat the classes as a check-the-box exercise.

Treating Mans Best Friend

JCCC alum Fareeha Lodhi started her work in the field of cancer treatment after completing the biotechnology program at KU Edwards. Lodhi is a laboratory manufacturing associate at ELIAS Animal Health in Kansas City. She studies immunotherapy treatment that creates cancer vaccines for canine patients.

Biotechnology is a vast field and is playing a vital role in the healthcare industry, especially the pharmaceutical and agricultural industry, she said. I was always fascinated by the lab environment, cell cultures and medicinal industry. To work in this field every day is a dream.

Start Your Journey

Ready to explore the field of biotechnology?Learn moreand check out oursteps to enroll!

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Updates from Johnson County Community College: Developing the future with biotechnology - Shawnee Mission Post

Scientists continuing to advance critical research on mechanisms of immune evasion exemplified by emerging SARS-CoV-2 variants

Study identifies the N-terminal domain of the SARS-CoV-2 spike protein as a target of potent neutralizing antibodies, but a target that can vary

Separate research results published in Cell characterize the virulence and antibody response to N439K, a prevalent variant of the SARS-CoV-2 receptor binding motif

SAN FRANCISCO, Feb. 01, 2021 (GLOBE NEWSWIRE) -- Vir Biotechnology, Inc. (Nasdaq: VIR) today announced the publication of new research characterizing a novel site of vulnerability on the SARS-CoV-2 (Severe Acute Respiratory Syndrome Coronavirus-2) spike protein specifically the N-terminal domain (NTD). The study findings were made available online on bioRxiv on January 14, 2021 and have been submitted to a peer-reviewed journal for future print publication. This manuscript, together with data on immune evasion by mutations elsewhere in the spike protein published by scientists in Cell, begin to paint a comprehensive picture of the mechanisms that SARS-CoV-2 may utilize to evade immunity. Collectively, these data indicate the importance of carefully targeting conserved regions of the spike for vaccines and clinical monoclonal antibodies.

The receptor binding motif (RBM) of SARS-CoV-2, the region of the receptor binding domain (RBD) that interacts with the SARS-CoV-2 receptor, is a common target of COVID-19 natural and vaccine-induced immune responses, as well as monoclonal antibodies. However, recently published research has characterized the frequent occurrence of mutations within the RBM, highlighting the need for targeting alternate sites within the spike protein.

This new research indicates the NTD is another site on the SARS-CoV-2 spike protein that, like the RBM, contains mutations as well as deletions in emerging variants, said Davide Corti, Ph.D., senior vice president of antibody research for Vir. Mutations in these immunodominant domains can evade natural immune responses and are of concern for vaccines and for therapeutic monoclonal antibodies targeting these regions. This underscores the need to advance therapies that have a high barrier to resistance.

Story continues

Little is known about neutralizing antibodies that bind to the NTD and their contribution to protection from infection and disease. In this new study, researchers at Vir, the University of Washington and other universities in the United States and Europe isolated and extensively characterized 41 human monoclonal antibodies that recognize the SARS-CoV-2 NTD. A subset of these NTD-specific monoclonal antibodies neutralize SARS-CoV-2 with potency similar to potential best-in-class monoclonal antibodies that target the RBD. Notably, several new SARS-CoV-2 genetic variants, including the widely prevalent variants identified in South Africa and the UK, were found to possess frequent mutations in the NTD.

These new findings build upon recent research published in Cell by Vir scientists in collaboration with colleagues at MRC-University of Glasgow Centre for Virus Research, which demonstrate the RBM of the SARS-CoV-2 spike protein a major target of neutralizing monoclonal antibodies is particularly variable.

Our ongoing effort to characterize the SARS-CoV-2 spike protein is proving ever more critical as new variants continue to emerge. These new findings reinforce the approach we have taken with our monoclonal antibody, VIR-7831, which is currently in Phase 3 trials, said George Scangos, Ph.D., chief executive officer of Vir. By targeting a very conserved region of the RBD, VIR-7831 was designed to be effective against SARS-CoV-2 and variants that might emerge in this outbreak or future outbreaks of related viruses.

The findings published in Cell characterize the virulence, fitness, clinical and epidemiologic impact, molecular features and immune response to N439K, a prevalent RBM variant of the SARS-CoV-2 spike protein first identified in Scotland in March 2020. Since then, a second lineage has independently emerged in other European countries, which, by January 2021, was detected in more than 30 countries across the globe. Although N439K variants are not believed to be more virulent or transmissible than the original SARS-CoV-2 strain, this research is the first to demonstrate mutations that maintain viral fitness can evade immunity.

To understand whether and how the N439K mutation might evade immunity, researchers in the findings published in Cell noted the binding of polyclonal sera to the SARS-CoV-2 spike was reduced by the mutation in a sizeable fraction of the 445 samples obtained from recovered individuals. Additionally, out of 144 human neutralizing mAbs isolated from individuals who recovered from SARS-CoV-2 infection early in the pandemic, a significant number failed to efficiently recognize N439K. When tested across four clinical-stage antibodies S309 (the precursor of VIR-7831), LY-CoV555, REGN10933 and REGN10987 S309, which targets a non-RBM epitope, LY-CoV555 and REGN10933 were capable of neutralizing the N439K variant.

About VIR-7831VIR-7831 is an investigational dual-action monoclonal antibody. Preclinical data suggest it has the potential to both block viral entry into healthy cells and an enhanced ability to clear infected cells. The antibody binds to an epitope on SARS-CoV-2 that is shared with SARS-CoV (the virus which causes SARS), indicating that the epitope is highly conserved, which may make it more difficult for resistance to develop. VIR-7831 also has been designed to achieve high concentration in the lungs to ensure optimal penetration into airway tissues affected by SARS-CoV-2 and to have an extended half-life.

About Vir BiotechnologyVir Biotechnology is a clinical-stage immunology company focused on combining immunologic insights with cutting-edge technologies to treat and prevent serious infectious diseases. Vir has assembled four technology platforms that are designed to stimulate and enhance the immune system by exploiting critical observations of natural immune processes. Its current development pipeline consists of product candidates targeting SARS-CoV-2, hepatitis B virus, influenza A, human immunodeficiency virus and tuberculosis. For more information, please visit http://www.vir.bio.

Vir Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as may, will, plan, potential, aim, promising and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These forward-looking statements are based on Virs expectations and assumptions as of the date of this press release. Forward-looking statements contained in this press release include, but are not limited to, statements regarding statements regarding print publication of Virs research in a peer-reviewed journal, the emergence of new SARS-CoV-2 variants, the identification of N-terminal domain as a target of potent neutralizing antibodies, the importance of advancing therapies that have a high barrier to resistance and the potential ability of VIR-7831 to evade such variants in the protection and treatment of COVID-19 and in the prevention of future pandemics of related coronaviruses. Many factors may cause differences between current expectations and actual results, including unexpected safety or efficacy data observed during preclinical or clinical studies, challenges in the treatment of hospitalized patients, difficulties in collaborating with other companies or government agencies, challenges in accessing manufacturing capacity, successful development and/or commercialization of alternative product candidates by our competitors, changes in expected or existing competition, delays in or disruptions to our business or clinical trials due to the COVID-19 pandemic, geopolitical changes or other external factors, and unexpected litigation or other disputes.

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Vir Biotechnology Announces New Data Highlighting the Importance of Targeting Conserved Regions of the SARS-CoV-2 Spike Protein in the Development of...

The 42 rating InvestorsObserver gives to Allovir Inc (ALVR) stock puts it near the middle of the Biotechnology industry. In addition to scoring higher than 41 percent of stocks in the Biotechnology industry, ALVRs 42 overall rating means the stock scores better than 42 percent of all stocks.

Searching for the best stocks to invest in can be difficult. There are thousands of options and it can be confusing on what actually constitutes a great value. Investors Observer allows you to choose from eight unique metrics to view the top industries and the best performing stocks in that industry. A score of 42 would rank higher than 42 percent of all stocks.

Our proprietary scoring system captures technical factors, fundamental analysis and the opinions of analysts on Wall Street. This makes InvestorsObservers overall rating a great way to get started, regardless of your investing style. Percentile-ranked scores are also easy to understand. A score of 100 is the top and a 0 is the bottom. Theres no need to try to remember what is good for a bunch of complicated ratios, just pay attention to which numbers are the highest.

Allovir Inc (ALVR) stock is down -5% while the S&P 500 is up 0.36% as of 1:25 PM on Wednesday, Feb 3. ALVR has fallen -$2.23 from the previous closing price of $44.63 on volume of 119,688 shares. Over the past year the S&P 500 is up 17.84% while ALVR is up 1377.35%. ALVR lost -$0.44 per share the over the last 12 months.

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Is Allovir Inc (ALVR) The Right Choice in Biotechnology? - InvestorsObserver

CAMBRIDGE, Mass., Feb. 2, 2021 /PRNewswire/ -- A collaboration between MIT Voigt Lab and Synlogic, Inc. (Nasdaq: SYBX), a clinical stage company bringing the transformative potential of synthetic biology to medicine, has been recognized by the Air Force Research Laboratory (AFRL) as a Biotechnology Grand Challenge Winner. One of four winning teams, the joint team comprised of MIT and Synlogic was awarded $1 million in an effort to spearhead innovation among small businesses in the field of biotechnology for the Department of Defense.

"We are honored to be recognized by the AFRL and are thrilled to collaborate with Synlogic to achieve this success," said Christopher Voigt, MIT Professor of Biological Engineering and Principal Investigator for the MIT Voigt Lab. "Our challenge was determining which organization would possess the proven expertise in both the development and manufacturing of novel biotherapeutic products, and we couldn't be happier that we have found that partner in Synlogic."

Christopher Voigt is an expert in synthetic biology and biotechnology with extensive research programs in defense, chemistry/materials, and agriculture. The focus of the Voigt Lab is to develop new experimental and theoretical methods to push the scale of genetic engineering, with the ultimate objective of genome design. This will impact the engineering of biology for a broad range of applications, including agriculture, materials, chemicals, and medicine. Professor Voigt's research spans applications for the Army, Navy, and Air Force, and he works closely with scientists across the service labs as well as hosting DoD researchers at MIT.

"Our internal and fully integrated Process Development & Manufacturing Sciences organization has demonstrated leading technical expertise in the field of Synthetic Biotic medicines and we look forward to applying innovative solutions for today's real-life challenges," said Antoine Awad, Synlogic's Chief Operating Officer."As we develop our internal pipeline we are excited to leverage our core capabilities to advance innovative partner projects, such as applying our bioprocess and manufacturing to advance the goals of the AFRL."

Together, Synlogic and the Voigt Lab will collaborate to generate and manufacture engineered strains by performing an assessment of process manufacturability, with optimization performed to maximize high cell density growth and high end of fermentation (EOF) viability. The goal of this work is to produce a live bacterial therapeutic that would improve pilot performance and decision-making when battling fatigue during long missions.

Learn more about Synlogic at http://www.synlogictx.com.

About Synlogic

Synlogic is bringing the transformative potential of synthetic biology to medicine. With a premiere synthetic biology platform that leverages a reproducible, modular approach to microbial engineering, Synlogic designs Synthetic Biotic medicines that target validated underlying biology to treat disease in new ways. Synlogic's proprietary pipeline includes Synthetic Biotic medicines for the treatment of metabolic disorders including Phenylketonuria (PKU) and Enteric Hyperoxaluria (HOX). The company is also building a portfolio of partner-able assets in immunology and oncology.

Forward-Looking Statements

This press release contains "forward-looking statements" that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, included in this press release regarding strategy, future operations, clinical development plans, future financial position, future revenue, projected expenses, prospects, plans and objectives of management are forward-looking statements. In addition, when or if used in this press release, the words "may," "could," "should," "anticipate," "believe," "estimate," "expect," "intend," "plan," "predict" and similar expressions and their variants, as they relate to Synlogic may identify forward-looking statements. Examples of forward-looking statements, include, but are not limited to, statements regarding the potential of Synlogic's platform to develop therapeutics to address a wide range of diseases including: cancer, inborn errors of metabolism, and inflammatory and immune disorders; the future clinical development of Synthetic Biotic medicines; the approach Synlogic is taking to discover and develop novel therapeutics using synthetic biology; and the expected timing of Synlogic's clinical trials including the Phase 1 study for SYNB1891 and SYNB8802 and the Phase 2 study of SYNB1618, and availability of clinical trial data from that study and other studies.

Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including: the uncertainties inherent in the clinical and preclinical development process; the ability ofSynlogicto protect its intellectual property rights; and legislative, regulatory, political and economic developments, as well as those risks identified under the heading "Risk Factors" inSynlogic'sfilings with theSEC. The forward-looking statements contained in this press release reflectSynlogic'scurrent views with respect to future events.Synlogicanticipates that subsequent events and developments will cause its views to change. However, whileSynlogicmay elect to update these forward-looking statements in the future,Synlogicspecifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing Synlogic's view as of any date subsequent to the date hereof.

SOURCE Synlogic, Inc.

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Arcutis Biotherapeutics Inc (ARQT) is near the top in its industry group according to InvestorsObserver. ARQT gets an overall rating of 64. That means it scores higher than 64 percent of stocks. Arcutis Biotherapeutics Inc gets a 76 rank in the Biotechnology industry. Biotechnology is number 24 out of 148 industries.

Finding the best stocks can be tricky. It isnt easy to compare companies across industries. Even companies that have relatively similar businesses can be tricky to compare sometimes. InvestorsObservers tools allow a top-down approach that lets you pick a metric, find the top sector and industry and then find the top stocks in that sector.

These rankings allows you to easily compare stocks and view what the strengths and weaknesses are of a given company. This lets you find the stocks with the best short and long term growth prospects in a matter of seconds. The combined score incorporates technical and fundamental analysis in order to give a comprehensive overview of a stocks performance. Investors who then want to focus on analysts rankings or valuations are able to see the separate scores for each section.

Arcutis Biotherapeutics Inc (ARQT) stock is lower by -3.74% while the S&P 500 is up 0.18% as of 11:53 AM on Wednesday, Feb 3. ARQT is down -$1.35 from the previous closing price of $36.10 on volume of 940,229 shares. Over the past year the S&P 500 has risen 16.24% while ARQT is up 35.53%. ARQT lost -$3.45 per share the over the last 12 months.

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Theres a lot to be optimistic about in the Healthcare sector as 2 analysts just weighed in on PDS Biotechnology (PDSB) and HCA Healthcare (HCA) with bullish sentiments.

PDS Biotechnology (PDSB)

In a report released today, Joseph Pantginis from H.C. Wainwright reiterated a Buy rating on PDS Biotechnology, with a price target of $6.00. The companys shares closed last Wednesday at $3.48.

According to TipRanks.com, Pantginis is a top 100 analyst with an average return of 47.3% and a 69.5% success rate. Pantginis covers the Healthcare sector, focusing on stocks such as Applied Genetic Technologies, Lineage Cell Therapeutics, and Catabasis Pharmaceuticals.

The word on The Street in general, suggests a Strong Buy analyst consensus rating for PDS Biotechnology with a $6.53 average price target.

See todays analyst top recommended stocks >>

HCA Healthcare (HCA)

Credit Suisse analyst A.J. Rice maintained a Buy rating on HCA Healthcare today and set a price target of $201.00. The companys shares closed last Wednesday at $170.81, close to its 52-week high of $174.55.

According to TipRanks.com, Rice is a 4-star analyst with an average return of 9.9% and a 63.9% success rate. Rice covers the Healthcare sector, focusing on stocks such as Genesis Healthcare, Acadia Healthcare, and Encompass Health.

HCA Healthcare has an analyst consensus of Strong Buy, with a price target consensus of $191.31, which is a 15.1% upside from current levels. In a report released yesterday, Oppenheimer also maintained a Buy rating on the stock with a $200.00 price target.

TipRanks has tracked 36,000 company insiders and found that a few of them are better than others when it comes to timing their transactions. See which 3 stocks are most likely to make moves following their insider activities.

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Analysts Offer Insights on Healthcare Companies: PDS Biotechnology (PDSB) and HCA Healthcare (HCA) - Smarter Analyst

Overall market sentiment has been high on PDS Biotechnology Corp (PDSB) stock lately. PDSB receives a Bullish rating from InvestorsObserver's Stock Sentiment Indicator.

Sentiment is a very short-term indicator that is entirely technical. There is no information about the health of profitability of the underlying company in our sentiment score.

As a technical indicator, news about the stock, or company, such as an earnings release or other event, could move the stock counter to the recent trend.

Price action is generally the best indicator of sentiment. For a stock to go up, investors must feel good about it. Similarly, a stock that is in a downtrend must be out of favor.

InvestorsObservers Sentiment Indicator considers price action and recent trends in volume. Increasing volumes often mean that a trend is strengthening, while decreasing volumes can signal that a reversal could come soon.

The options market is another place to get signals about sentiment. Since options allow investors to place bets on the price of a stock, we consider the ratio of calls and puts for stocks where options are available.

PDS Biotechnology Corp (PDSB) stock is trading at $3.81 as of 3:18 PM on Tuesday, Feb 2, a rise of $0.19, or 5.25% from the previous closing price of $3.62. The stock has traded between $3.48 and $3.92 so far today. Volume today is more active than usual. So far 665,239 shares have traded compared to average volume of 485,122 shares.

To see InvestorsObserver's Sentiment Score for PDS Biotechnology Corp click here.

PDS Biotechnology Corp operates as a clinical stage biotechnology company, principally involved in drug discovery in the United States. It is primarily engaged in the treatment of various early-stage and late-stage cancers, including head and neck cancer, prostate cancer, breast cancer, cervical cancer, anal cancer, and other cancers. Its products are based on the proprietary Versamune platform technology, which activates and directs the human immune system to unleash a powerful and targeted attack against cancer cells.

Click Here to get the full Stock Score Report on PDS Biotechnology Corp (PDSB) Stock.

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PDS Biotechnology Corp (PDSB) Stock: What Does the Chart Say? - InvestorsObserver

A rating of 81 puts Codexis, Inc. (CDXS) near the top of the Biotechnology industry according to InvestorsObserver. Codexis, Inc.'s score of 81 means it scores higher than 81% of stocks in the industry. Codexis, Inc. also received an overall rating of 64, putting it above 64% of all stocks. Biotechnology is ranked 33 out of the 148 industries.

Finding the best stocks can be tricky. It isnt easy to compare companies across industries. Even companies that have relatively similar businesses can be tricky to compare sometimes. InvestorsObservers tools allow a top-down approach that lets you pick a metric, find the top sector and industry and then find the top stocks in that sector.

These rankings allows you to easily compare stocks and view what the strengths and weaknesses are of a given company. This lets you find the stocks with the best short and long term growth prospects in a matter of seconds. The combined score incorporates technical and fundamental analysis in order to give a comprehensive overview of a stocks performance. Investors who then want to focus on analysts rankings or valuations are able to see the separate scores for each section.

Codexis, Inc. (CDXS) stock is trading at $26.13 as of 10:16 AM on Tuesday, Feb 2, a rise of $2.22, or 9.28% from the previous closing price of $23.91. The stock has traded between $24.93 and $26.71 so far today. Volume today is light. So far 253,983 shares have traded compared to average volume of 799,470 shares.

Click Here to get the full Stock Score Report on Codexis, Inc. (CDXS) Stock.

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Is Codexis, Inc. (CDXS) the Top Pick in the Biotechnology Industry? - InvestorsObserver

The 39 rating InvestorsObserver gives to Ovid Therapeutics Inc (OVID) stock puts it near the middle of the Biotechnology industry. In addition to scoring higher than 36 percent of stocks in the Biotechnology industry, OVIDs 39 overall rating means the stock scores better than 39 percent of all stocks.

Searching for the best stocks to invest in can be difficult. There are thousands of options and it can be confusing on what actually constitutes a great value. Investors Observer allows you to choose from eight unique metrics to view the top industries and the best performing stocks in that industry. A score of 39 would rank higher than 39 percent of all stocks.

These rankings allows you to easily compare stocks and view what the strengths and weaknesses are of a given company. This lets you find the stocks with the best short and long term growth prospects in a matter of seconds. The combined score incorporates technical and fundamental analysis in order to give a comprehensive overview of a stocks performance. Investors who then want to focus on analysts rankings or valuations are able to see the separate scores for each section.

Ovid Therapeutics Inc (OVID) stock is trading at $2.89 as of 2:58 PM on Tuesday, Feb 2, an increase of $0.09, or 3.21% from the previous closing price of $2.80. The stock has traded between $2.70 and $3.10 so far today. Volume today is more active than usual. So far 3,194,206 shares have traded compared to average volume of 1,863,832 shares.

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Should You Buy Ovid Therapeutics Inc (OVID) in Biotechnology Industry? - InvestorsObserver