Barron's (blog) | Earnings Preview: Biotechnology Looks Healthy - Focus on Funds ... Barron's (blog) Healthcare stocks are getting a modest lift on Friday, gaining 0.24% while the S&P 500 has risen 0.15%. Within that group biotechnology stocks seem to be ... |
View original post here:
Earnings Preview: Biotechnology Looks Healthy - Focus on Funds ... - Barron's (blog)
SUNNYVALE, Calif., April 3, 2017 /PRNewswire-iReach/ -- Three business and scientific leaders with early-stage investors today announced the formation of Apostle Inc, a biotechnology company developing a novel bioinformatics-enabled nanotechnology aimed for early cancer detection. This new approach will enable the early assessment of the cancerous signals in human peripheral blood plasma, which is believed to have a significant impact on the global healthcare landscape in both developed countries and emerging markets.
Dr. David Dongliang Ge, an experienced business and scientific leader who was President of BioSciKin Co. and Director of Bioinformatics at Gilead Sciences, will lead the new company. He is joined by two colleagues as co-founders of Apostle and his investment partners. "Biotechnologies, especially those focusing on novel diagnostic or therapeutic advancements aiming for cancer, are among the key focuses in the global economy for the next 5-20 years. By 2020, the market size ofcancerdiagnosis is estimated to reach $168.6 billion. Apostle represents one of these focuses." Dr. Ge said. "With a groundbreaking bioinformatics-enabled nanotechnology approachwe want to inform the general population that we are able to help them identify cancer signals, earlier and more accurate than conventional techniques, and potentially advise their doctors to take highly effective surgical actions. "
"It's been a great pleasure to have the opportunity to work with David and his team on this amazing venture. We're thrilled to work with this scientifically imaginative and visionary company." One of the investors said. Apostleis funded by Amino Capital, ShangBay Capital, Westlake Ventures in the Silicon Valley and a group of individual investors from both the Silicon Valley and China. Apostle is advised by Dr. Charles Cantor, an American molecular geneticist, former director of the Department of Energy Human Genome Project, a member of the National Academy of Sciences, as well as Dr. Hongyu Zhao, the Ira V. Hiscock Professor of Biostatistics and Professor of Statistics and Genetics, Chair of the Biostatistics Department and the Co-Director of Graduate Studies of the Inter-Departmental Program in Computational Biology and Bioinformatics at Yale University.
About Apostle Inc.
Apostle Inc is a biotechnology company in Sunnyvale, CA. It's in the business of the research, development, licensing, and sales of novel bioinformatics-enabled nanotechnologies and the related intellectual properties, products, and services for diagnosis and treatment of human diseases
About the founder team of Apostle Inc.
Dr. David Dongliang Geis CEO and President of Apostle. Previously, he was President of BioSciKin Co. and Simcere Diagnostics Co., two global biotechnology companies headquartered in Nanjing, China. Between 2011 and 2016, he was Director of Bioinformatics at Gilead Sciences, where he founded and provided leadership to the bioinformatics group. Dr. Ge and his group led the phylogenomic analytical support for the critical regulatory approval of Sovaldi, a world-leading anti-HCV drug. In 2014 and 2015, Dr. Ge was invited to be a member of the U.S. NHGRI Special Emphasis Panel. He was appointed as Assistant Professor of Biostatistics and Bioinformatics at Duke University School of Medicine. He received his Ph.D.ofBiostatistics and Genetic Epidemiology from Peking Union Medical College and Chinese Academy of Medical Sciences in 2004. Dr. Ge's work in discovering the IL28B genetic variants associated with the clinical treatment responses, published in Nature in 2009, has received over 3000 times of citations with the U.S. FDA's citation in its several guidance for industry. The invention was licensed to LabCorp and QuestDiagnostics,and has become clinical diagnostic services since then (LabCorp 480630 and Quest AccuType IL28).Dr. Ge has authored over 70 original articles, including 5 in Nature and 1 in Science, in total receiving over 15,000 citations. Dr. Ge was named by the U.S. Genome Technology magazine as one of the "Rising Stars" in 2009, and by the U.K. Phacilitate as one of the "Top 50 Most Influential People in Big Data" in 2015.
Read More
Bo Zhang, Ph.D.is VP of Chemistry of Apostle. Dr. Zhang received his Ph.D.ofChemistry from Stanford University in 2015 and received his B.S.ofChemistry from Peking University in 2010. Dr. Zhang has won the Gold Medal of National Chemistry Olympiad of China in 2006. Dr. Zhang has 10 years of experience in nanotechnology research, with outstanding achievements in developing novel nanomaterials with unique fluorescence characteristics. Dr. Zhang published over 30 original paperson Nature Medicine, Nature Materials, Nature Photonics, Nature Communications, etc. Dr. Zhang's two articles in Nature Medicine about novel nano-platform for type 1 diabetes and Zika virus infection diagnosis have attracted worldwide attention. Dr. Zhang has been PI for research projects funded by the NIH. He holds many patents. Dr. Zhang was the recipient of Materials Research Society Awards, Mona M. Burgess Fellow, William S. Johnson Fellowship, etc.
Xin Guo, Ph.D.is VP of Bioinformatics of Apostle. Previously, Dr. Guo was group leader at Gilead Sciences, in charge of the clinical phylogenomic program for developing Sovaldi. Dr. Guo received his Ph.D. in Computer Sciences from Duke University and M.S. in Informatics from Max Planck Institute of Germany. He received his B.S. in Informatics from Chiba Institute of Technology of Japan. Dr. Guo has over 10 years of experience in the R&D ofhigh performancecomputing, machinelearningand artificial intelligence. Dr. Guo has extensive experience in product development of complex algorithms and databases, with applications in genomic big data.
Wenqi Zeng, MD,PhD, FACMGis Chief Medical Advisor of Apostle. He is Chief Medical Officer of Simcere Diagnostics Co. Previously, Dr. Zeng was Senior Director of Molecular Genetics at Quest Diagnostics and was Director of Clinical Genomics at Ambry Genetics. Dr. Zeng was fellow of Clinical Molecular Genetics and Medical Genetics at Harvard. He received his M.D. from Xiang-Ya Medical School in China and Ph.D. in MolecularPatholgy/Molecular Genetics fromUniversityof Otago. He holds Diploma of American Board of Medical Genetics and Genomics(ABMGG),and is a qualified CAP inspection team leader, and a qualified CAP CLIA lab director in CA,FLand MD. He also has NY state COQ in molecular genetics and molecular oncology.
Media Contact: Public Relations, Apostle, Inc, Apostle, Inc, 650-483-5437, pr@apostlebio.com
News distributed by PR Newswire iReach: https://ireach.prnewswire.com
See the original post here:
Apostle Inc, a Biotechnology Company for Early Cancer Detection, is Founded in the Silicon Valley - Yahoo Finance
NEW YORK, April 3, 2017 /PRNewswire/ -- Use this report to: - Explore present and future strategies within the bioseparation systems market. - Learn about the upcoming developments, the holdups and the needs of the market. - Gain an insight into acquisition strategies and collaborations by companies.
Read the full report: http://www.reportlinker.com/p0619255/Separation-Systems-for-Commercial-Biotechnology.html
- Receive an overview of the relevant patents related to the industry.
Highlights - The global market for bioseparation reached $18.4 billion in 2015. This market is expected to increase from $19.0 billion in 2016 to nearly $24.0 billion in 2021 at a compound annual growth rate (CAGR) of 4.7% for 2016-2021. - United States market for bioseparation is expected to grow from $7.0 billion in 2016 to nearly $9.3 billion at a CAGR of 5.9% from 2016 through 2021. - Emerging market for bioseparation is expected to grow from $7.0 billion in 2016 to $8.7 billion in 2021 at a CAGR of 4.4% from 2016 through 2021.
Introduction & Scope
Introduction
Study goals and objectives In recent years, the bioseparation systems (separation systems in biotechnology) segment has been one of growth in the biopharmaceuticals market. Primary use of these systems is for separation and purification of biological products. BCC Research's goal in conducting this study is to provide an overview of the current and future characteristics of the global market for various bioseparation systems. This report explores present and future strategies within the bioseparation systems market. The market is categorized into liquid chromatography, centrifugation, electrophoresis, membrane filtration, flow cytometry, microarray, labonachip, biochip, and magnetic separation. The upcoming developments of the market, the holdups and the needs of the market are discussed in this report. The classifications, comparisons and usage of these products are also portrayed in this report. A detailed analysis of the structure of the bioseparation systems industry has been conducted. The revenues have been broken down by region and sales figures are estimated for the fiveyear period from 2016 through 2021. The report also covers significant patents and their allotments in each category.
Acquisition strategies and collaborations by companies are also covered in this report. This study also discusses the strengths and weaknesses of each type in light of new technologies, growing competition, and changing customer needs.
Reasons for doing this study Bioseparation systems have a major place in the biopharmaceutical and biotechnology industry. Bioseparation is conducted on biological products like proteins, nucleic acids, and cell cultures, among others. The increasing demand for biopharmaceutical products is driving the global market for bioseparation systems. Increased research in life sciences, newer technological developments are taking bioseparation techniques to prodigious heights. Modern industries have now begun to explore the advantages of bioseparation systems in their production processes, which have led to a steady market. Research and development (R&D) spending, along with increasing competition and patent expiries are giving a new direction to the market. This study looks at almost all the systems affected by these factors.
Contributions of the study and for whom This study contributes to the areas of market growth for the manufacturers and users of bioseparation systems. Genomic research centers, academic institutions, government and private laboratories, as well as pharmaceutical, diagnostic and biotechnology companies will find this study to be of interest.
Scope of report The market for bioseparation systems is growing rapidly across all regions. Bioseparation purifies biological products on a largescale. The report focuses on the global market of bioseparation systems and provides an updated review, including basic design and its applications, in various arenas of biomedical and life science research. The scope of the study is global. BCC Research analyzes each market, new products and advancements, technologies involved, market projections and market shares. The geographical regions covered in the report are North America, Europe and emerging markets. The emerging market covers all countries like India, China, Japan, Korea, Taiwan, Africa, Australia, New Zealand, and Canada, among others. The bioseparation techniques that are covered in this report are chromatography, centrifugation, electrophoresis, membrane filtration, flow cytometry, microarray, labonachip, biochip, and magnetic separation. Among chromatography techniques, liquid chromatography is the most active market.
Also included in the report are relevant patent analysis and comprehensive profiles of companies that lead the bioseparation systems market. Key players include Thermo Fisher Scientific, Agilent Technologies Inc., BioRad Laboratories, Danaher Corp., Qiagen N.V., Merck KGaA GmbH, and Waters Corp. among others.
Information sources Many companies were surveyed to obtain data for this study. Included were manufacturers and end users of bioseparation systems. Data was gathered from various industry sources. BCC Research spoke with officials within the industry, consulted newsletters, company literature, product literature, and a host of technical articles, journals, indexes, and abstracts. Exhaustive investigations of databases by key terminology were completed. In addition, data were compiled from current financial, trade, and government sources.
Methodology Read the full report: http://www.reportlinker.com/p0619255/Separation-Systems-for-Commercial-Biotechnology.html
About Reportlinker ReportLinker is an award-winning market research solution. Reportlinker finds and organizes the latest industry data so you get all the market research you need - instantly, in one place.
__________________________ Contact Clare: clare@reportlinker.com US: (339)-368-6001 Intl: +1 339-368-6001
To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/separation-systems-for-commercial-biotechnology-300433779.html
Read the rest here:
Separation Systems for Commercial Biotechnology - Yahoo Finance - Yahoo Finance
In terms of pure biotechnology, Europe has embraced innovation. However, it cannot compete with the US yet because it cannot drive private investment in the field, as well as open up the market to new products, a pharmaceutical executive told EURACTIV.com in Lyon.
Despite the EUs consistent growth in the biotech business, the EBE claims that the industry is not receiving enough support from investors, universities or research institutions, thus limiting the EUs ability to keep pace with the US in biotechnology.
The EU is lagging behind due to challenges in translating scientific innovations into successful businesses, a European Biopharmaceutical Enterprises (EBE) report claims.
Biotechnology is the use of living systems or organisms in the creation of industrial products. The growth of the biotechnology industry is important for Europe and created 10,000 new jobs and 93 medicines recommended for market authorisation by the European Medical Agency in 2015, according to the EBE.
Biotechnology could help patients across Europe gain access to innovative therapies, for example, against rare diseases. Proponents of bio-medicines also claim that precision therapy, because it is more efficient, will ease the burden on member states ailing healthcare systems.
The EBE suggests that steps should be taken to create a stronger investor community for biotech products to prevent places other than Europe from benefitting economically from technology invented and developed in Europe.
License to fail
The paper suggests that European entrepreneurs may be more adverse to risk because they have no license to fail, citing the lack of a strong culture of institutions or individuals seeking useful application of their work, taking out patents and creating start-up companies.
On the other hand, universities in the US often empower scientists to be knowledgeable in business and management.
The paper recommends that European institutions improve their support of scientists in marketing their technologies through better investment in Technical Transfer Offices (TTOs). The current lack of funding for TTOs at European universities means it is difficult for them to attract and train experienced staff.
Although Europe has public research funding organisations, such as the Innovative Medicines Initiative (IMI) and the European Commissions Horizon 2020, the lack of mature biotech companies makes the investment ecosystem fragile and makes it difficult for Europe to compete with the US for funding, the paper says.
Europe needs to build a bigger and better capital market for biotech companies to overcome the funding gap that prevents the needed growth of the biotech sector, it reads. The EBE suggests the European Commission create a single capital market for biotech companies and the creation of tax incentives for investment in biotechnology.
Being successful in the US
Didier Hoch, chairman of the Biovision 2017- The World Life Sciences Forum in Lyon, told EURACTIV that there are several reasons why biotechnology can flourish more easily in the US than in Europe.
According to Hoch, in terms of pure biotechnology, Europe is not lagging behind the US, as its sufficiently innovative. Where we are lagging behind is to drive investment in the field and attract private investors and open up the market to new products, he noted.
In fact, in the US the norm is to have a connection between the science, universities and private investors [] which is not yet the case in Europe, where there is a kind of fear when you are in the public sector to go private said Hoch, adding that another hindrance is the lack of trust between the public and private sector
Another difference between Washington and Brussels is the source of money. Hoch explained that money invested in the US biotech sector was coming from private investors, while in Europe, it comes from venture capital funds mainly funded by the EU institutions.
Even venture capitals are funded from EU money. This regime could eventually be thestrength for Europe, as in a way it can be competitive against private US money, he emphasised.
However, Hoch insisted that Europe still needed to convince more private sector entities to invest in biotechnology. It might be a long-term and risky field, but in the US the private sector invests in its potential, he said.
Hoch stressed that currently a biotech product could be considered successful if it has accessed the US market.
If you have a biotech company you should have in mind first to succeed in the US, even if you are based in Europe, he explained, explaining that in terms of the market, 70% of a new products success is in the US.
If you dont get your product there you will face difficulties, he said, emphasising that its mainly a political decision to have the US as an attracting market.
Last but not least, Hoch pointed out that its easier to get to the US market because there is a clear way to access and not like 27 different in the Europe, which have a country-based approach.
Making Europe innovative
In February, the centre-right European Peoples Party (EPP) presented its vision for the future of the Economic and Monetary Union (EMU) and emphasised the need for anew framework on access to financing in order for innovative companies to be encouraged to invest in Europe.
EPP President Joseph Daul told EURACTIV that the EU should become an innovation hub as this is the key to future growth and help it compete with the US.
This is where we need to concentrate our efforts to make Europe the worlds best talent hub. We should embrace radical innovations and make our continent the birthplace of the next Facebook or Apple, he told EURACTIV.
The EPP recognises that Europe was lagging behind compared to the US regarding innovative companies and, therefore, suggested the creation of an environment that will help new talents flourish.
We must understand that this follows partly from structural factors in our continent compared to our partners on the other side of the Atlantic. Venture Capital Funds in the EU are on average small. We need to support creating Funds of Funds, and we must look into existing regulations to make sure that investing in private equity funds is not discouraged by regulations and capital rules, the paper reads.
*Hannah Black contributed to this article.
Go here to see the original:
Europe's biotechnology potential hindered by investment fears - EurActiv
The UF business incubator Sid Martin Biotechnology Institute was named the 2017 Top Global Incubator of the Year.
The International Business Innovation Association recognized the institute March 28, said Mark Long, the institutes director. The institute received $1,500 for winning the award out of 30 other incubators.
The biotechnology institute provides lab space, equipment, business and legal advice at a low cost for new biotech companies, Long said.
Scientists need help understanding business and addressing the market, he said. Were here to help them out with that.
The institutes 40,000 square foot facility is at Progress Park in Alachua. Its used as office and laboratory space thats rented out to new companies unable to afford commercial space.
Getting an award like this is a real marketing tool in attracting new companies and investors for these companies, Long said.
He said since the institute started in 1995, businesses theyve served have a 78 percent success rate, meaning 78 percent of businesses stay open after the first five years. Since 2003, the success rate has improved to 93 percent.
Meekah Chaderton, a manager at the startup food development company Captozyme, said the institute helped improve the companys business.
Chaderton said Captozyme plans to move out of the institute and into their own space in June.
Small companies cant afford to buy a lot of equipment and lab space, so renting affordable space from Sid Martin has made us more competitive, Chaderton said.
Read more from the original source:
UF biotechnology institute named Incubator of the Year - The Independent Florida Alligator
Iran has made a considerable breakthrough in biotechnology inasmuch as it is able to produce GM foods and Up until 2013 it has produced 18 different kinds of recombinant medicines.
The modern biotechnology has been established nearly nine decades ago in Iran, started with vaccine production in Pasteur and Razi Institutes in 1920 and 1925. National Institute of Genetic Engineering and Biotechnology institute of Iran was established in 1989. Iranian scientists are active in various spheres of agriculture in this institute and work on medicinal plants with the aim of using their metabolites or increasing their tolerance to non-biological changes such as salinity or drought. One of the uses of biotechnology is in production of genetically modified foods; however, there are many opposing voices claiming that they are harmful for health.
Simply said, biotechnology harnesses cellular and bi molecular processes and puts them to work for us. It is used for production of GM foods and treating diseases with genetic technologies and many other fields. Biotechnology is an efficient, up-to-date and effective tool in agricultural field. Biotechnology helps you to improve plants' resistance to a considerable amount. Iran is among pioneering countries in this field. Up until 2013, 18 different kinds of recombinant drugs have been produced in Iran. This number is against 50 recombinant drugs produced globally. With the help of biotechnology and recombinant drugs, Iran has seen a 30% drop in its drug export and 50% inflation growth has been controlled.
Read the original post:
Biotechnology in Iran - Press TV
The president of DSM Food Specialties, Ilona Haaijer, has told FoodBev that shes really excited to be able to offer laboratory and scale-up facilities as part of its new biotechnology centre in the Netherlands.
The company unveiled the Rosalind Franklin Biotechnology Center on its Delft campus earlier, where more than 400 scientists will advance the companys research into food enzymes, cultures, bio-preservatives and taste ingredients for the global food industry.
Alongside significant investments in robotics and automation, the centre and the surrounding campus includes space for start-ups to explore and scale up their concepts in partnership with DSM Food Specialties.
At the opening: Alex Clere
There was a general buzz, a sense of excitement at the unveiling of DSMs imposing glass biotechnology centre this morning. DSMs scientists had already moved in, keen to give visitors an impression of the new equipment some the result of millions of euros worth of investment and collaborative spaces in action.
Ahead of the unveiling ceremony, DSM Food Specialties president Ilona Haaijer told me which of the companys products she thought were particularly pertinent, given the state of the food industry at the moment.
Its MaxiLact product, which removes lactose from a product while delivering additional sugar reductions, was flying, she said. And the Preventase proprietary enzyme allows brands to limit the amount of acrylamide in bakery items amid widespread concern across Europe.
This new centre, a major achievement for DSM, will help the Food Specialties business continue to meet the industrys biggest trends and satisfy changes to consumer preference.
The Rosalind Franklin Biotechnology Center is part of DSMs network of more than 30 laboratories in ten countries. According to Gerhard Wagner, the director of DSMs Biotechnology Center, the company has sought to align itself with local technology hubs like Boston, Massachusetts and put down roots close to its markets.
Haaijer also noted that the world was becoming an increasingly volatile, uncertain, complex and ambiguous (VUCA) place, which made the prediction of future trends difficult.
The process was no longer as linear as it had once been, becoming an art, not a science.
But in that challenge was the opportunity for DSM to increase its participation with external stakeholders, like Delft University of Technology and Corbion.
The biotechnology centre in Delft has also been designed with the help of DSMs scientists, and includes features and open spaces deliberately intended to encourage cooperation and collaboration between employees.
Haaijer claimed that it was more and more important to open up with chief operating officer Cindy Gerhardt adding that this was the only way companies can be early to market with a product.
The Rosalind Franklin Biotechnology Center will play a crucial role in that strategy.
Originally posted here:
DSM 'excited' by biotechnology opportunites, president says ... - FoodBev.com
Breakthrough Therapy Designation is described on the FDA website as "a process designed to expedite the development and review of drugs that are intended to treat a serious condition and preliminary evidence indicates that the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint(s)." It was signed into law in 2012, with the first full approval of a breakthrough designation candidate being only one year later. As of March 30, 2017, FDA has granted breakthrough therapy designation to 170 of the 505 total requests, and eventually approved 55 breakthrough therapy designated products.
The concept makes sense. If a new drug that aims to treat serious and life-threatening conditions shows unprecedented effect in early clinical trials, patients should not have to wait to receive treatment. A group called Friends of Cancer Research worked with partners in advocacy, regulation, drug development, and bipartisan congressional champions to take breakthrough therapy designation from concept to an expedited FDA development program. This ensures patient access to revolutionary drugs is as quick and effective as possible. A drug that receives breakthrough therapy designation is eligible for all FDA fast track features, intensive FDA guidance on an efficient development program (as early as phase 1), and organizational commitment involving FDA senior project managers.
FDA bases its decision to grant breakthrough therapy designation on scientific support for clinical endpoint(s). Studies that demonstrate a drug's effect on a surrogate or intermediate clinical endpoint must be "adequate and well controlled" as required by the FD&C Act. Using surrogate or intermediate endpoints can save valuable time in the drug approval process. Consider an example of cancer patients. Rather than wait for a study to complete a potentially lengthy overall survival measurement, FDA may approve a drug based on evidence of tumor shrinkage, associated with a shorter measure such as progression-free survival, because it is considered reasonably likely to predict clinical benefit (and hence prolonged survival of patients).
This well written article about the drug development process addresses the process and is worth a quick read. A cancer drug development company will still need to conduct studies to confirm that tumor shrinkage actually predicts that patients will live longer, which is sometimes a phase 3 or even a phase 4 clinical trial. One common question often asked by StrongBio stock club members (send email to join, its free) is, "will a company have to wait to market a drug until trials assessing secondary endpoint data or confirmational long-term effects of drugs on a patient population are completed"? So the answer can be yes or it can be no. The industry currently anticipates that primary consideration for marketing approval by FDA is primary endpoint result(s). So it depends what the primary endpoint of the trial is predetermined to be with FDA, in an advanced declaration called a special protocol assessment. Though caution is warranted when predicting clinical trial result interpretation by FDA, it is clear that shorter endpoint measures such as progression free survival were specifically developed by scientists and clinicians (over many years with massive resource allocation) as reliable metrics for early approval.
As a biotechnology stock investor, one valuable tool for learning about what therapeutic candidates FDA might favor, is the Friends of Cancer Research list of FDA Breakthrough Therapy Designations. If you have not included this or Knect365 lists as part of your due diligence, please consider doing it now. These lists consist of many indications in medicine, not just cancer. Many, but not all, of the stocks on this list have performed well, and having FDA in a supportive role behind a drug candidate has proven to have boosted confidence in these stocks when reviewed in articles analyzing how they are priced by the Street. Since excitement surrounds the designation, an increased stock price can be used to generate funds for the company to begin early manufacturing initiatives. In this way investors help serve those in need of life-saving therapies by funding faster production in hopes for a future payoff. Everyone can win in this positive scenario.
Genentech [Roche Holdings, (OTCQX:RHHBY)], with 15 breakthrough therapy designations, is a leader in the breakthrough designation category, with several rare and specialty indications. But with its multiple players and large market cap, it's more difficult to measure an effect of a breakthrough therapy on stock price. Factors that an investor should consider when looking at the designation is the potential market compared to company market cap. So Immunomedic's (NASDAQ:IMMU) Sacituzumab Govitecan breakthrough therapy designation for triple negative breast cancer with a 6 billion dollar market and only 600 million dollar market cap might be seen as more attractive in contrast to RHHBY (market cap 216 billion) rituximab designation for pemphigus vulgaris, a rare autoimmune disease causing skin and mucosal membrane blisters, with estimated market in the low hundreds of millions. At the time (February 2016) IMMU reported its breakthrough therapy designation it was trading at about 2 dollars per share, and is now about 6.50 about a year later (after several futile attempts by short-sellers to discredit the company ultimately at breast cancer victim's expense), compared to RHHBY, which has moved from about 31 dollars per share since its Mar 21, 2017 announcement to 32 dollars this week. It is extremely unlikely rituximab will drive RHHBY to 105 dollars one year from now to match IMMU's market performance of Sacituzumab Govitecan. However, one should never underestimate the ability of big pharma to gain an expedited product approval and then have that product used for other indications "off label" when other treatments fail. For instance, rituximab has implications in treating Lupus, with an increasing 3.5 billion dollar industry by 2025. For the purpose of breakthrough therapy designation affecting stock price, StrongBio will focus on a few publicly traded (Novimmune, Rebiotix, and Rhythm are interesting but privately held companies) small market cap representatives in this article in order to make some conclusions, referring to larger market cap companies as a point of reference.
Like IMMU, Adaptimmune (NASDAQ:ADAP) received breakthrough therapy status, but for affinity enhanced T-cell therapy targeting NY-ESO in synovial sarcoma in February 2016. With a market cap of under 400 million and a potential market in the low hundreds of millions per year in synovial (and other off label or future indication) sarcomas, this is certainly an attractive investment to StrongBio if weakness in market price should occur. Some investors regard ADAP as some of the best cancer work being done right now, and recommends it as a good investment in the 200 billion dollar immunotherapy cancer space. Having raised some funds recently and having strong partners, the stock has decreased in value from about 7 dollars per share to about 5.50, but has some recent positive momentum after raising funds in an offering at just over 4 per share. It was first covered by StrongBio at 4 dollars earlier this year. IMMU and ADAP have both shown to be somewhat volatile following breakthrough therapy designation, warranting scrutiny of timing before entering a long position based upon breakthrough designation.
Another stock, like ADAP, that has trended down since its breakthrough designation by FDA is Trevena (NASDAQ:TRVN). TRVN has dropped over 50% since designation, February 22, 2016, shooting from 7 dollars per share to about 9 dollars per share, but is now trading at 3.65 per share one year later. TRVN's oliceridine, an acute pain control drug for treating moderate to severe post-bunionectomy or abdominoplasty, even met its phase 3 trial endpoints for pain control. But as this article summarizes well, may be seen as too expensive compared to morphine and other pain killers. This article by the Street makes a good case for TRVN in how oliceridine met pain control endpoints and potentially offers an advantage in a profile of side-effects including nausea, vomiting, and depressed breathing. However some of the side effects were not (yet) reported as statistically significant. With analyst price targets of 12 dollars and slew of legal class action threats that mimic the ones that IMMU had before its rapid price ascension, it is probably likely that once short sellers have covered TRVN will reach its targets. Certainly one to watch given this share weakness if one likes to use a contrarian approach. We know from StrongBio research done on the plastic surgery industry in previous articles that the industry is rapidly growing, and people don't seem to mind paying expensive prices. A more expensive but better pain killer may not be seen as a negative after all.
Kite Pharma (NASDAQ:KITE), market cap 1.8 billion, received FDA breakthrough therapy designation in December, 2015 for its refractory aggressive non Hodgkin lymphoma candidate KTE-C19. The cancer market is in the 100 billion range, so this stock should be on just about every biotechnology enthusiast's radar. At that time KITE was trading at about 75 dollars per share after a ramp up from about 50 per share earlier that fall. The price of KITE settled back to about 40 to 50 per share from January 2016 to January 2017, only recently increasing to its current 78 dollar level. KTE-C19 is therapy in which a patient's T cells are genetically modified to express a chimeric antigen receptor targeting the CD19 maker, a protein expressed on the cell surface of B cell lymphomas and leukemia. Its breakthrough designation includes treatment of diffuse large B cell lymphoma, primary mediastinal B cell lymphoma, and transformed follicular lymphoma. Investors are optimistic due to early studies which have demonstrated 31% "curative" complete responses and remission in chemorefractory diffuse large B cell lymphoma patients after a single treatment. Analyst targets for KITE are at an average of 86 dollars per share. Timing is critical for a long position in this company, and as volatile as the share price has been over the last 2 years, anything is possible. Ironically, this stock has remained flat in spite of the volatility since breakthrough designation.
Juno pharmaceuticals (NASDAQ:JUNO) [breakthrough designation December 2016 for JCAR017 for treatment of relapsed/refractory aggressive large B-cell maladies], Novartis, (NYSE:NVS) [forPKC412 midostaurin for adults with FLT3+ AML and LEE011 combination with letrozole for treatment of HR+/HER2- advanced or metastatic breast cancer], and Bellicum pharmaceuticals (BLCM) [no breakthrough candidate] are also operating in this B cell cancer area, with emphasis being put on safety by limiting graft versus host risks of these robust anti-cancer therapies. Juno, with a 2.5 billion dollar market cap might be undervalued. Having recently discontinued development of its nicely active anti-cancer JCAR015 for ALL, due to safety issues, combined with its early FDA favor for JCAR017 plus immunosuppression regimen, and strong cash position of nearly 1 billion, one can make a good investment case on a further pullback. Immunosuppression drugs, cytokines, T-Cell, and stem cell therapies are all approaches designed to make these therapies less likely to attack healthy tissues. BLCM just raised money in an offering at 12 dollars per share, has a market cap of 330 million, and analysts average target at 27.50. StrongBio regards this option as potentially the best potential market to market cap ratio, should BLCM succeed in pulling down a share. Uniquely, BLCM technology involves modifying donor immune cells with a "kill switch" that is activated with administration of rimiducid. In an ongoing trial with 122 pediatric patients receiving partially matched donor stem cell transplants, five cases of uncontrolled graft versus host disease were resolved by the rimiducid-activated kill switch. Juno, Novartis, and Kite are good investment candidates with plenty of up-side, but the dominant market share will go to the company that best suits safety needs in graft versus host reaction. NVS is a giant with a monster market cap of 174 billion, making it more difficult to obtain a high return due to any sole candidate. So in this case perhaps riding the wing of an FDA breakthrough therapy status candidate could provide the best investment opportunity, via BLCM acquisition or stand-alone data. This creates a new category of investment candidates and fits the StrongBio contrarian outlook.
Exelixis Inc. (NASDAQ:EXEL), with a 6 billion market cap, was granted breakthrough therapy designation by FDA for renal cell carcinoma with one prior therapy. As a more mature representative of the speculative designation class, its chart reflects a little more of a steady classic upward stair than a volatile up and down nausea inducer. Since the launch of its kidney drug, Cabometyx, has grown to about 27% of the 1 billion dollar market in renal cancer. At the time of designation, it traded at about 9 dollars per share, and now trades at about 21 dollars per share 18 months later. Having made efforts to decrease its debt, and expand its pipeline, and make international partners including Takeda Pharmaceuticals in Japan, the company is stabilizing and poised for stock growth, even with its fairly large market cap. The value of stability and income can never be underappreciated, nor can a nice stepwise ascension in stock price over 100% per year.
uniQure N.V. (NASDAQ:QURE), a Dutch gene therapy company, received breakthrough therapy designation for AMT-060, its investigatory gene therapy in patients with severe hemophilia B. With a market cap of only 145 million dollars, its stock price is relatively flat since the announcement Jan 30, 2017. QURE has received regulatory approval in the European Union and carries a relatively low valuation compared to its peers, including Bluebird bio (NASDAQ:BLUE), Avalanche (AAVL), and most recently Spark Therapeutics (NASDAQ:ONCE). Briefly, gene therapy offers curative potential by inserting a gene encoding the expression of a therapeutic protein with a single administration. When a gene encoding a blood clotting protein is missing or mutated in hemophilia B patients, QURE technology introduces a copy of the proper gene to restore the presence of the clotting factor, preventing uncontrolled bleeding. Given its small market cap and high reward to risk ratio in this 10 billion full market for hemophilia, QURE could have some potential upward volatility in its future.
Tonix Pharmaceuticals (NASDAQ:TNXP) is a unique company because it received breakthrough therapy designation in December 2016 for its post-traumatic stress disorder drug candidate, TNX-02 SL. TNX-102 SL is a protective eutectic oral formulation of cyclobenzaprine that allows for a rapid systemic exposure and increased bioavailability through transmucosal delivery to modulate sleeping cycles. Scientific mechanism of action is to block serotonin receptor 2A, associated with an increase in restorative slow wave sleep and a decrease in waking after sleep onset. With a market cap around only 18 million, there would seem to be a lot of upside to this reward to risk analysis. Tonix has advanced its candidate TNX-02 SL to phase 3. But TNXP is also plagued by typical early stage biotechnology company challenges, including having recently reverse split its stock to stay listed on the Nasdaq exchange, and recently raised 8 million in capital in an offering, providing the company with approximately 30 million in operating capital. Recently TNXP enrolled its first military related post-traumatic stress disorder patient in its study. Because this stock has not made much of a move yet, some potential for upward volatility remains for TNXP stock. Because there is a likelihood of another raise of cash, StrongBio would advise caution in investing heavily in spite of the wonderful cause.
The full scope of breakthrough designation grants is beyond the scope of a Seeking Alpha article, but demonstrated is the main point that FDA breakthrough therapy designation lists yield fascinating investment candidates. Remember there are no sure things in the stock market, and that investing in biotechnology includes a lot of variability in results, risks, and volatility. Investment strategies previously published by StrongBio best include timing entries of positions, making good critical selections of key growth, and optimizing foreseeable market favor. One way to maximize the chances of an optimal result for market favor is to diversify the portfolio with companies that have obtained FDA breakthrough therapy designation, especially when perceived as undervalued. Though there are no guarantees that the market is going to reward investors short term, in the long run it appears that most breakthrough designation candidates meet with success eventually. The charts also caution that volatility may be associated with these picks. StrongBio recommends putting candidates with FDA breakthrough therapy designation on the watch list and hedge in on pullbacks.
Disclosure: I am/we are long IMMU.
I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.
Additional disclosure: Secondary tickers include RHHBY, IMMU, ADAP, TRVN, KITE, BLCM, EXEL, JUNO, QURE, BLUE, AAVL, ONCE, TNXP but were not listed as options
The rest is here:
Impact Of FDA Breakthrough Therapy Designation Speculative Biotechnology Stock Performance - Seeking Alpha
(Photo: http://mma.prnewswire.com/media/485639/VSY.jpg )
VSY Biotechnology considers it important to note that this is a ruling by the German Court of First Instance. VSY Biotechnology has the right to and will appeal this judgement with the Higher District Court and if necessary with the Federal Supreme Court in Germany. It is expected that a final ruling on the infringement may take several years and German Court's ruling is only effective in Germany but not in all over the world.
VSY Biotechnology B.V. reserves its right to seek material and moral indemnity for all direct and indirect damages of VSY Biotechnology on basis of unfair competition and defamation due to incomplete press release of Carl Zeiss dated March 27, 2017. Further VSY Biotechnology will ask for all damages they may suffer from the decision of the First German Court in case of District Court or Federal Court rule in favor of VSY Biotechnology.
Additionally, VSY Biotechnology applied for invalidation of Zeiss Patent EP 2 377 493 B1 before EPO with the claim of Zeiss Patent has lack of novelty, lack of inventive step, therefore unpatentable.
VSY filed opposition against Zeiss patent
VSY Biotechnology B. V. (VSY) has, amongst others, filed an opposition against Carl Zeiss Meditec A.G.'s (Zeiss) European patent EP 2 377 493 B1 "Method for manufacturing aphakic intraocular lens" (EP'493) with the European Patent Office (EPO) on May 6, 2016. Zeiss acquired EP'493 from the German IP advisers IP Strategists GmbH who acquired the patent from the Japanese company Menicon Co..VSY is of the opinion that EP'493 does not fulfil the requirements of patentability as it lacks novelty and inventive step, is insufficiently disclosed and includes extension of subject matter.
The patent regards Trifocal intraocular lenses. Trifocal lenses of Zeiss are AT LISA tri and the AT LISA tri toric.
The opposition is still pending.
All details of the opposition can be found on: https://register.epo.org/application?number=EP09837427&lng=de&tab=doclist
About VSY Biotechnology BV
VSY Biotechnology is one of the leading companies in Industry of ophthalmology focusing on cataract surgery, producing premium intra ocular lenses and viscoelastics. For more information, please visit company website. http://www.vsybiotechnology.com.
SOURCE VSY Biotechnology
The rest is here:
Patent Case of Carl Zeiss Meditec AG and VSY Biotechnology B.V. - PR Newswire (press release)
by Zacks Equity Research Published on April 04, 2017
ANTH APOP
Cellect Biotechnology Ltd. (APOP - Free Report) was a big mover last session, as the company saw its shares rise over 10% on the day. The move came after the company announced that it has received a formal notice of Intention to Grant for a patent covering a key method of treatment from the European Patent Office. This also led to far more shares changing hands than in a normal session. This breaks the recent trend of the company, as the stock is now trading above the volatile price range of $5.94 to $10.90 in the past one-month time frame.
None of the estimates for this stock were revised in the last 30 days and the Zacks Consensus Estimate also remained unchanged. Yesterdays price action is encouraging though, so make sure to keep a close watch on this firm in the near future.
Currently, Cellect Biotechnology carries a Zacks Rank #3 (Hold).
A better-ranked stock in the same industry is Anthera Pharmaceuticals, Inc. (ANTH - Free Report) , sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of todays Zacks #1 Rank stocks here.
Is APOP going up? Or down? Predict to see what others think: Up or Down
Zacks Best Private Investment Ideas
While we are happy to share many articles like this on the website, our best recommendations and most in-depth research are not available to the public. Starting today, for the next month, you can follow all Zacks' private buys and sells in real time. Our experts cover all kinds of trades from value to momentum . . . from stocks under $10 to ETF and option moves . . . from stocks that corporate insiders are buying up to companies that are about to report positive earnings surprises. You can even look inside exclusive portfolios that are normally closed to new investors. Click here for Zacks' private trades >>
Excerpt from:
Cellect Biotechnology (APOP) Jumps: Stock Moves 10.5% Higher - Zacks.com
Nasdaq | Cellect Biotechnology Gets European Patent (APOP) Investopedia secured a European patent covering a method of treatment from the European Patent Office. The patent covers cell-based therapeutics of Cellect's technology and method that have the potential to treat diseases like diabetes, graft-versus-host disease, ... BRIEF-Cellect Biotechnology receives formal notice of intention to grant for a patent from European patent office Cellect Biotechnology (APOP) Granted European Patents Protecting ... Cellect Receives Notice of Intention to Grant from European Patent ... |
Original post:
Cellect Biotechnology Gets European Patent (APOP) - Investopedia
04 Apr 2017 --- DSM has opened a new state-of-the-art biotechnology facility at its site in Delft, the Netherlands that will expand its research and development capabilities in fermentation and biotechnology for food applications. The site is really focused on biotech and fermentation, says Ilona Haaijer, President of DSM Food Specialties. The new Biotechnology Center is a further step in the development of the site, where DSM Food Specialties has its global headquarters. The completion of this new Biotechnology Center is part of a 100 million investment program by DSM to scale up R&D in the Netherlands since 2013.
The new center brings together over 400 highly-skilled scientists from around the world who conduct breakthrough research in advanced fermentation technology, processing, genetics, analytics and food technology. Haaijer tells FoodIngredientsFirst: Technology plays a key role in finding solutions. We need to find a way to feed all the people and need to find a way to do it in a healthy way. We believe passionately in our purpose of enabling better food for everyone. We can apply our science-based competences and creativity to really unlock value for customers to create new innovations.
Click to EnlargeOne example of a breakthrough innovation is DSMs development of fermented steviol glycosides the reduced-calorie, sweet-tasting molecules in the stevia plant as an answer to the growing global demand for sugar reduced food and beverages. DSMs fermentation know-how helps meet this global growing demand for steviol glycosides of a high purity and reliable quality that are sustainably produced. Another breakthrough innovation is PreventASe, an enzyme that reduces acrylamide levels in baked goods, says Haaijer.
DSM has also invested together with other industry players in a state-of-the-art biotech fermentation pilot plant on the Delft site. The new center makes use of the latest advances in laboratory robotics and automation to expand R&D and food application development. Its location at the heart of the Biotech Campus Delft allows DSM to rapidly scale up promising food applications for customer validation and commercial roll-out.
In addition, with the current infrastructure, DSM can facilitate start-up or small companies with their production, making sure that innovative ideas reach the market. DSM is part of a food hub, our collaboration is with TU Delft, the city of Delft, and many academic institutions. We have science, scale up facilities and more lab facilities here, so we can host start-up and small companies, offering access to science and lab facilities, says Haaijer.
Click to EnlargeFeike Sijbesma, CEO/Chairman of the DSM Managing Board, commented: DSMs new Biotechnology Center is where our scientists create solutions for societal challenges such as the need to provide all people globally with nutritious food, as well as enabling the transformation from a fossil-based to a bio-renewable-based society. DSM Biotechnology Center facilitates these needs, in an innovative environment and at an historic location in Delft where we build nearly 150 years of scientific, academic and commercial activities.
The building itself has sustainable features with 3000m2 of glass panes and a glass roof of 22x9 meters allow ample daylight into the building, making it very transparent and light. A Dutch climate faade removes hot air from behind the glass panels, and is used to heat cold air coming in from outside the building, thus reducing energy consumption. Haaijer adds; What is interesting about this building, is the way it has been set up. It is a sustainably designed building, and each floor has its own competence. The flow of work is easy, and people from all research areas can find each other easily.
Click to EnlargeThis was also very clear during the tour through the building. Each floor is especially designed for its purpose and also focused on automation, relieving the labor intense load on the employees. One floor is designed for FIND, where initial screening of their huge bacterial strain library takes place, whereas another floor is especially designed for MAKE, where the bioprocess development takes place. Our core technologies help us predict the effect of enzymes and microorganisms so we can select the perfect fermentation organisms and help us quantify bioprocess options and scale production sizes before transferring to factories, says Gerhard Wagner, Director of the DSM Biotechnology Center. On the ground floor, the APPLY of the ingredient or enzyme is investigated, characterizing the ingredients up to even the atom level using state-of-the-art Nuclear Magnetic Resonance technology.
DSMs Biotechnology Center will be named the Rosalind Franklin Biotechnology Center in honor of pioneering scientist Rosalind Franklin (1920-1958), whose extraordinary work during a tragically short life and career significantly contributed to our understanding of the structure of DNA, effectively creating the basis for modern biotechnology. By honoring Rosalind Franklin, DSM pays tribute to all female heroes of science.
By Maartje Geraedts in Delft
Food Ingredients News
04 Apr 2017 --- Sugar remains the key ingredient delivering the sweetness and great taste that consumers are looking for, specifically in the chocolate and confectionery sectors. The quest to combine taste and health is driving NPD, as the industry faces the challenge of balancing public demand to reduce added sugars and create indulgent experiences, while at the same time presenting clean label products.
Business News
04 Apr 2017 --- The Masan Group Corporation has revealed how global investment firm KKR has begun a definitive agreement to invest US$250 million in Masan Group and in its branded meat platform, Masan Nutri-Science.
Business News
04 Apr 2017 --- British multinational consumer goods company Reckitt Benckiser is considering selling off its food division at an estimated US$2 billion as it prepares to acquire infant formula maker Mead Johnson Nutrition.
Food Ingredients News
04 Apr 2017 --- As part of Brexit negotiations, the UK governments Great Repeal Bill will end the supremacy of EU law in Britain, an aspect at the very core of the UKs motivation for leaving the EU.
Business News
04 Apr 2017 --- CP Kelco have announced the completion of new production capabilities in its Okmulgee, Oklahoma plant for manufacturing KELCOGEL gellan gum. This expansion of gellan gum production capacity enables the company to respond to growing market demand for this high-performance product line, used in a wide range of food, beverage and other applications.
Visit link:
DSM Expands RD Capabilities for Food Applications With ... - FoodIngredientsFirst
ALACHUA, Fla., April 3, 2017 /PRNewswire/ --Sid Martin Biotechnology Institute (SMBI), the leading biotechnology incubator at the University of Florida, has been awarded the Randall M. Whaley Incubator of the Year award for 2017, the highest award given by the International Business Innovation Association (InBIA). InBIA is the world's leading organization for advancing business incubation, acceleration and entrepreneurship. SMBI was named Incubator of the Year among more than 7,500 incubators worldwide. The annual award, sponsored by the Friends of the University Science Center in Philadelphia, recognizes the top global business incubation program and includes a cash prize.
The award was presented on March 28th at the InBIA's 31st Annual International Conference on Business Incubation. Accepting the award for SMBI were Mark S. Long, Director, and Merrie Shaw, Assistant Director. SMBI also received another award, the 2017 Technology/Science Entrepreneurship Center Program.
David L. Day, Assistant Vice President for Technology Transfer at the University of Florida, said, "We are honored for the Institute to be recognized as the best in the world incubator. It is a tribute to our staff and their outstanding efforts helping startups grow great innovations and new solutions into successful businesses that will make the world a better place."
SMBI has a biotechnology focus, and over the past 21 years has served more than 100 startup companies in biotechnology, biomedicine and bioagriculture. The Institute has created more than 2,200 high-tech jobs since its inception, and SMBI resident companies have accumulated over $1.62B in capital and M&A activity. There is a 93% survival rate for companies that entered the SMBI program since March of 2003, and an overall 78% survival rate for all companies served over the past 21 years.
Since becoming Director of SMBI in January 2016, Long has overseen the admission of 13 new companies, and the graduation of three companies. "We continue to see the growth of North Central Florida as a biotech hub," said Long. "As part of the University of Florida's Research Foundation, we are able to offer new biotechnology startups a tremendous wealth of resources, advisement and equipment. We are proud to be recognized by our peers as the top incubation program in the world."
About Sid Martin Biotechnology Institute at the University of Florida
The Sid Martin Biotechnology Institute (SMBI) is the leading biotechnology incubator headquartered at the University of Florida in Alachua, Florida at Progress Park. SMBI has been honored with national and international awards for incubator excellence and achievements in technology commercialization, funding access, job creation and technology-based economic development. It is dedicated to mentoring and accelerating the growth of innovative early-stage bioscience and biotechnology companies, and supporting the economic growth of the North Central Florida region. For more information, visit sidmartinbio.org.
Contact:Merrie Shaw, Assistant Director, Sid Martin Biotechnology Institute, 386-462-0880, mashaw@ufl.edu, sidmartinbio.org
Related Files
Sid Martin Biotechnology Institute-Logo.png
Mark Long, Director, and Merrie Shaw, Assistant Director, Sid Martin Biotechnology Institute 2017 InBIA Awards.jpg
This content was issued through the press release distribution service at Newswire.com. For more info visit: http://www.newswire.com
To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/university-of-floridasid-martin-biotechnology-institute-receives-2017-top-global-incubator-award-from-the-international-business-innovation-association-300433133.html
SOURCE Sid Martin Biotechnology Institute at the University of Florida
Continue reading here:
University of Florida/Sid Martin Biotechnology Institute Receives ... - PR Newswire (press release)
LOS ANGELES--(BUSINESS WIRE)--Puma Biotechnology, Inc. (Nasdaq: PBYI), a biopharmaceutical company, announced that results from an ongoing Phase II clinical trial of Puma's investigational drug PB272 (neratinib) were presented at the 2017 American Association for Cancer Research Annual Meeting (AACR) that is currently taking place in Washington, D.C. The presentation entitled, Neratinib in HER2 or HER3 mutant solid tumors: SUMMIT, a global, multi-histology, open-label, phase 2 basket study, was presented as a plenary session by David Hyman, M.D., Director of Developmental Therapeutics at Memorial Sloan Kettering Cancer Center (MSK), and principal investigator of the trial.
The Phase II SUMMIT basket trial is an open-label, multicenter, multinational study to evaluate the safety and efficacy of PB272 administered daily to patients who have solid tumors with activating HER2 or HER3 mutations. All patients received loperamide (16 mg per day initially) prophylactically for the first cycle of treatment in order to reduce the neratinib-related diarrhea.
Included in the presentation were data on 141 patients enrolled in the neratinib monotherapy arm of the trial, including 124 patients with HER2 mutations and 17 patients with HER3 mutations. This included patients with 21 unique tumor types, with the most common being breast, lung, bladder and colorectal cancer. There were also 30 distinct HER2 and 12 distinct HER3 mutations observed among these patients, with the most frequent HER2 variants involving S310, L755, A755_G776insYVMA and V777.
In the HER2-mutant cohort, clinical responses were observed in tumors with S310, L755, V777, P780_Y781insGSP and A775_G776insYVMA mutations. When stratified by tumor type, responses were observed in patients with breast, cervical, biliary, salivary and non-small-cell lung cancers, which led to cohort expansions in these tumor types. No activity was observed in the HER3-mutant cohort. A more detailed presentation of the data is presented in Table 1 below and a copy of the full presentation is available on the Puma Biotechnology website.
HER2mut
HER2mut
HER2mut
HER2mut
HER2mut
HER2mut
HER3mut
Lung
(95% CI)
rate, n (%)
(95% CI)
20.1
(95% CI)
(0.5--NA)
The neratinib safety profile observed in the SUMMIT study is consistent with that observed previously in metastatic patients with HER2 amplified tumors. With anti-diarrheal prophylaxis and management, diarrhea was not a treatment-limiting side effect in SUMMIT. The interim safety results of the study showed that the most frequently observed adverse event was diarrhea. For the 141 patients enrolled in the neratinib monotherapy arm with safety data available, 31 patients (22%) reported grade 3 diarrhea. The median duration of grade 3 diarrhea for those patients was 2 days. 4 patients (2.8%) permanently discontinued neratinib due to diarrhea and 21 patients (14.9%) temporarily discontinued neratinib due to diarrhea and then restarted after the diarrhea subsided.
Dr. David Hyman stated, "Neratinib showed signs of clinical activity in several of the cohorts in the SUMMIT trial. The safety profile of the drug was manageable and the diarrhea was not treatment-limiting with appropriate prophylaxis and management. We look forward to completing enrollment in the ongoing cohorts in the study and continuing to utilize the basket trial design to explore possible treatment options for these select patient populations.
"The basket-trial design we are utilizing for SUMMIT is enabling us to evaluate the clinical potential of neratinib in patients with specific mutation-types rather than limiting exploration to one tumor type at a time. It is an efficient approach that is generating clinically meaningful information to guide targeted therapy across a broad spectrum of tumor types with HER mutations, including in patients with rare tumors who may not otherwise have access to investigational therapies, said Alan H. Auerbach, Chief Executive Officer and President of Puma Biotechnology. We are very pleased with the preliminary activity seen with neratinib in the SUMMIT trial. We look forward to advancing this targeted compound into further clinical development in multiple HER2 mutant tumor types, both as monotherapy and in novel combinations."
About Puma Biotechnology
Puma Biotechnology, Inc. is a biopharmaceutical company with a focus on the development and commercialization of innovative products to enhance cancer care. The Company in-licenses the global development and commercialization rights to three drug candidatesPB272 (neratinib (oral)), PB272 (neratinib (intravenous)) and PB357. Neratinib is a potent irreversible tyrosine kinase inhibitor that blocks signal transduction through the epidermal growth factor receptors, HER1, HER2 and HER4. Currently, the Company is primarily focused on the development of the oral version of neratinib, and its most advanced drug candidates are directed at the treatment of HER2-positive breast cancer. The Company believes that neratinib has clinical application in the treatment of several other cancers as well, including non-small cell lung cancer and other tumor types that over-express or have a mutation in HER2. Further information about Puma Biotechnology can be found at http://www.pumabiotechnology.com.
Forward-Looking Statements:
This press release contains forward-looking statements, including statements regarding the development of the Companys drug candidates. All forward-looking statements included in this press release involve risks and uncertainties that could cause the Company's actual results to differ materially from the anticipated results and expectations expressed in these forward-looking statements. These statements are based on current expectations, forecasts and assumptions, and actual outcomes and results could differ materially from these statements due to a number of factors, which include, but are not limited to, the fact that the Company has no product revenue and no products approved for marketing; the Company's dependence on PB272, which is still under development and may never receive regulatory approval; the challenges associated with conducting and enrolling clinical trials; the risk that the results of clinical trials may not support the Company's drug candidate claims; even if approved, the risk that physicians and patients may not accept or use the Company's products; the Company's reliance on third parties to conduct its clinical trials and to formulate and manufacture its drug candidates; the Company's dependence on licensed intellectual property; and the other risk factors disclosed in the periodic and current reports filed by the Company with the Securities and Exchange Commission from time to time, including the Company's Annual Report on Form 10-K for the year ended December 31, 2016. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. The Company assumes no obligation to update these forward-looking statements, except as required by law.
March 31, 2017 9:38am NASDAQ:BBC
From Zacks: After being stressed by the twin attacks of higher drug pricing and increased regulatory scrutiny, the biotech sector has made a strong comeback in the first quarter of 2017.
In fact, BioShares Biotechnology Clinical Trials ETF (BBC Free Report) tops the list of the best performing ETFs of the quarter, with impressive returns of about 27.4%. BBC carries a Zacks ETF Rank of 3 or Hold rating with a High risk outlook.
The surge in the fund was largely driven by cheap valuation, robust earnings results and a slew of positive actions taken by the President. In particular, Trump promised to reduce federal regulations by 7580% and streamline the Food & Drug Administration (FDA) approval process. This would make it easier for biotech companies to bring new products to the market. Trumps proposed tax reforms and cash repatriation policy are also supporting the rally (read: Top ETF Stories of Q1 from Wall Street).
Apart from these, encouraging industry trends including the possibility of increased M&A activity, an accelerated pace of innovation, promising drug launches, growing importance of biosimilars, cost-cutting efforts, an aging population, expanding insurance coverage, the growing middle class, an insatiable demand for new drugs, and ever-increasing health care spending are fueling growth in the sector.
Lets take a closer look at the fundamentals of BBC and its performance.
BBC in Focus
This fund has a novel approach to biotechnology investing with exposure to companies that are in the clinical trials stage. This can easily be done by tracking the LifeSci Biotechnology Clinical Trials Index. BBC is a small cap centric fund, having amassed $24.4 million in its asset base. It charges 85 bps in fees per year from investors and trades in light average daily volume of around 14,000 shares.
Holding 70 stocks in its basket, it is widely spread out across various components with none holding more than 3.34% share. Though almost all the stocks in the funds portfolio delivered strong returns, a few were the real stars that more than doubled their size (read: Hit ETFs & Stocks from the Top Sector of February).
Below we have highlighted those five best-performing stocks in the ETF with their respective positions in the funds basket:
Best Performing Stocks of BBC
Esperion Therapeutics Inc. (ESPR Free Report) : The stock has surged about 185% so far this year and carries a Zacks Rank #3 with solid Industry rank in the top 39%. Most of the gains came on hopes of the Food and Drug Administrations (FDA) approval to the cholesterol-lowering medicine bempadoic acid. However, Esperion saw its earnings estimates deteriorating from a loss of $3.46 to a loss of $6.27 for this year over the past 90 days. It also has an unfavorable VGM Style Score of F. ESPR occupies the top spot in the funds basket with 3.3% of the total assets (see: all the Health care ETFs here).
Global Blood Therapeutics Inc. (GBT Free Report) : This stock takes the second position in the funds basket with 2.8% allocation. It has also delivered incredible returns of 169% in the first quarter on rumors of the takeover of a big pharma name like Novo Nordisk (NVO). The stock saw its earnings estimates moving from a loss of $2.89 to a loss of $2.83 for this year over last the 90 days. Further, it belong to a solid Industry with a Zacks Rank in the top 43%. The stock has a Zacks Rank #3 with a VGM Style Score of F.
TG Therapeutics Inc. (TGTX Free Report) : It currently has a Zacks Rank #3 with a VGM Style Score of F. The stock soared nearly 150% in the first quarter with most upside coming after positive study results from its phase 3 clinical trial of treatment for high-risk leukemia patients. However, TG Therapeutics saw negative earnings estimate revision of a nickel for the current year over the past 30 days and has an ugly Zacks Industry rank in the bottom 32%. The stock is the third firm and accounts for 2.7% share in BBC (read: Trump Tweet on Drug Pricing Hits Biotech and Pharma ETFs).
Cara Therapeutics Inc. (CARA Free Report) : The stock has been climbing since the start of the year and has gained about 105.5% this quarter on the pending trial results of its lead drug candidate. It hit a new one-year high of $20.90 in the last trading session after the company announced positive results from part A of a phase 2/3 trial for chronic kidney disease-associated pruritus. Cara Therapeutics has a solid Zacks Industry rank in the top 43%. However, it has a Zacks Rank #4 (Sell) with a VGM Style Score of F. The stock occupies the fourth position in the funds portfolio, making up for 2.5% share.
NewLink Genetics Corporation (NLNK Free Report) : This stock takes the seventh spot in the funds basket with 2.2% of assets. It has doubled this quarter but saw negative earnings estimate revision of $1.21 for this year over the past 90 days. NewLink Genetics currently has a Zacks Rank #3 with a VGM Style Score of F and solid Zacks Industry rank in the top 43%.
The BioShares Biotechnology Clinical Trials Fund (NASDAQ:BBC) was unchanged in premarket trading Friday. Year-to-date, BBC has gained 25.75%, versus a 5.59% rise in the benchmark S&P 500 index during the same period.
BBC currently has an ETF Daily News SMART Grade of A (Strong Buy), and is ranked #23 of 36 ETFs in the Health & Biotech ETFs category.
This article is brought to you courtesy of Zacks Research.
Tags: biotech Equity Health Care NASDAQ:BBC Zacks
Categories: NASDAQ:BBC
Read the original:
BioShares Biotechnology Clinical Trials Fund(NASDAQ:BBC ... - ETF Daily News (blog)
Biotechnology is a top-notch field of study that emerged into the scientific world as a result of revolutions in Biology, Chemistry, Informatics, and Engineering. It is considered to be an applied branch of Biology. Biotechnology helps out this old and respectable field of science keep up with the pace of time and remain competitive in the contemporary world.
With a Master in Biotechnology, students will study the use of living organisms and bioprocesses in technology, engineering, medicine, agriculture and results in all kinds of bioproducts, from genetically modified food to serious cutting-edge devices used to carry out gene therapy. Students in Master in Biotechnology programs may also explore bioinformatics, which is the application of statistics and computer science to the field of molecular biology. Bioinformatics is extremely important for contemporary biological and molecular researches because the data amount there grows by geometric progression and it is necessary to have adequate technology to process it. Bioinformatic methods are widely used for mapping and analyzing DNA and protein samples, as well as for the study of genetics and molecular modeling. Biotechnology and Bioinformatics do a great favour to traditional fields of study, refreshing them with new methods of research, which allows their drastic development, and you can make your contribution with a Master in Biotechnology degree.
Find out about various Master in Biotechnology programs by following the links below. Don't hesitate to send the "Request free information" form to come in contact with the relevant person at the school and get even more information about the specific Master in Biotechnology program you are interested in.
Originally posted here:
Best Master's Degrees in Biotechnology 2017
By Elizabeth Johnson
Leading pharmaceutical and biotechnology companies chose INTERPHEX 2017 to launch their newest products, with 20 companies debuting new technology at the pharmaceutical and biotechnology industry trade show held March 21-23 at the Jacob K. Javits Convention Center in New York City.
In its 38th year, INTERPHEX offered attendees a mix of content including more than 104 conference education sessions, INTERPHEX Live discussions, hundreds of exhibits and product launches.
The show experienced attendee growth, compared with 2016, and attributes much of that to its robust program.
INTERPHEX offers its customers the opportunity to bring their entire teams and engage in education for everyone, said Melissa Ashley, senior vice president of INTERPHEX.
She continued, Attendance is free to those who register ahead to support the industry and allow companies full teams to experience all that is happening in the industry.
Having grown and evolved from a regional to a national and international event, INTERPHEX selected New York as its home because the city is a gateway that allows people to come from abroad and because there are a lot of customers in the tri-state area.
INTERPHEX is reflective of the industry advancing to the future, with organizers working to ensure the needs of technology companies are on display.
Still, the biotechnology industry is slower to change than some industries because it is heavily regulated, according to Kate Scott McCorriston, director of marketing and technical content for INTERPHEX.
The regulations mean people need to attend to learn about new guidance and regulations, McCorriston explained.
She added, Young professionals need to attend to learn how to manufacture new products within regulations and cost-effectively.
Unique features such as INTERPHEX Live keep attendees engaged.
Unlike standard panels or lectures or even exhibitor-led education, INTERPHEX Live discussions allow participants to ask questions and engage in a direct dialogue with experts, with sessions taking place out in the open and not far from registration, making it easy for people to join the discussions.
In addition, INTERPHEX organizers solicit customer feedback to make sure they are hitting the mark with show programming.
We ask, who do they want more of and what research do they need? Ashley said.
She continued, Then, we put that information together with feedback from our technical advisory board in order to create the best program we can.
In addition to showcasing the latest technology, the show itself uses a lot of technology to provide the best experience for attendees and exhibitors, including online matchmaking tools pre-show so that attendees can customize their experience and understand who they want to target before they arrive.
The show invested in a lead retrieval tool that helps exhibitors really know who they are talking to as well.
We want people to engage, not just walk up and down the aisles and leave, Ashley explained.
The goal of INTERPHEXs show organizers was to reach more attendees using the technology they had available, and it appears they got their wish, with a positive response to those tools.
INTERPHEX is sponsored by the Parenteral Drug Association (PDA) and brings over 11,500 global industry professionals and more than 625 industry-leading suppliers together to Learn it, Experience it, Procure it annually.
INTERPHEX 2018 will take place April 19-21 at the Javits Center.
Continued here:
20 New Biotechnology Products Debut at INTERPHEX 2017 - TSNN Trade Show News (blog)
NEW YORK, NY / ACCESSWIRE / March 31, 2017 / Prana Biotechnology and Xenetic Biosciences both saw their company's stock prices soar on news of a broader, more global product distribution. Prana is continuing to expand its presentation of PBT-434, while Xenetic is moving ahead with its strategic planning goals to make its product technology available to a larger geographical area.
RDI Initiates Coverage:
Prana Biotechnology Limited https://ub.rdinvesting.com/news/?ticker=PRAN
Xenetic Biosciences Inc. https://ub.rdinvesting.com/news/?ticker=XBIO
Prana Biotechnology advanced 37.65% to close at $3.40 on Thursday. The stock traded in a wide range between $4.58 and $2.75 during the day on a volume of 11.95 million shares traded. The company has presented new data from its Reach2HD trial at the American Neurological Association Annual Meeting held in Baltimore. Its primary candidate drug, PBT-434, demonstrated pre-clinical evidence that the drug will help with the treatment of movement disorders of patients with Parkinson's Disease.
Prana Biotechnology, an Australian company, for the half-year period ending December 31, 2016, reported total operating expenses of $6.05 million AUD, a pre-tax income of $3.65 million AUD, and a loss of $0.68 AUD per share.
Access RDI's Prana Biotechnology Research Report at: https://ub.rdinvesting.com/news/?ticker=PRAN
Xenetic Biosciences accelerated to advance 44.30% to close at $5.44 on Thursday. The stock traded between $5.61 and $3.87 on volume of 180,793 shares traded. Xenetic has been aggressively promoting its products internationally, and the rise in price is due in part to it becoming a member of the NASDAQ community on March 30th. The company has been expanding its patent portfolio to a number of countries, including Europe and the United States. Currently, their major marketable product is PolyXen technology platform. The product's IP on its PolyXen technology platform will afford protection on average for the next 10 to 12 years.
The latest financial report with period ending September 30, 2016, showed the company posting $2.25 million in operating expenses, a net loss of $2.47 million, and net loss per share of $0.28 and it had about $212,000 of cash assets on its books as on September 30th.
Access RDI's Xenetic Biosciences Research Report at: https://ub.rdinvesting.com/news/?ticker=XBIO
Our Actionable Research on Prana Biotechnology Limited (NASDAQ: PRAN) and Xenetic Biosciences Inc. (NASDAQ: XBIO) can be downloaded free of charge at Research Driven Investing.
Research Driven Investing
We are committed to providing relevant and actionable information for the self-directed investor. Our research is reputed for being a leader in trusted, in-depth analysis vital for informed strategic trading decisions. The nimble investor can leverage our analysis and collective expertise to execute a disciplined approach to stock selection.
RDInvesting has not been compensated; directly or indirectly; for producing or publishing this document.
Disclaimer: This article is written by an independent contributor of RDInvesting.com and reviewed by Nadia Noorani, CFA charter holder. RDInvesting.com is neither a registered broker dealer nor a registered investment advisor. For more information please read our full disclaimer at http://www.rdinvesting.com/disclaimer.
CONTACT
For any questions, inquiries, or comments reach out to us directly at:
Address:
Research Driven Investing, Unit #901 511 Avenue of the Americas, New York, NY, 10011
Email:
CFA and Chartered Financial Analyst are registered trademarks owned by CFA Institute.
SOURCE: RDInvesting.com
Original post:
Prana Biotechnology and Xenetic Biosciences Expand Their Product Promotion - Yahoo Finance
Prana Biotechnology Limited (ADR) (NASDAQ:PRAN)
Prana Biotechnology Limited (ADR) (NASDAQ:PRAN) shares have been up over 80% on large volumes. PRAN closed yesterday at $2.48, gapped up to open at $2.95, reached an inter-day high of $4.58, and are now trading around $3.60 for an inter-day gain of over 45%. The nano-cap Australian-based biotech firm has, prior to todays action, an average daily trading volume of just over 59,000 but, by 10:30 AM EST, PRAN shares had already traded over 7.1 million times. A review of news services reveals that no news has been reported by the company or an analyst that could account for todays price action.
Prana Biotechnology Limited (ADR) (NASDAQ:PRAN) is a clinical stage biotechnology firm that develops therapeutic medicines. Prana has developed PBT-2 for the treatment of Alzheimers disease. PBT-2 is currently in a Phase IIa clinical trial. Pranas PBT-2 is also being investigated for applications involving other therapeutic applications including age-related cataracts, Huntington disease, Creutzfeldt-Jakob disease, Motor Neuron disease, age-related macular degeneration, cancers, Parkinsons disease, and other neurodegenerative diseases.
When PRAN is adjusted for dilutive effects, the shares high came in early 2014 when PRAN was trading near $80/share. However, by the end of 2014, PRAN shares would end up down over 74%. Dilution, EPS losses, and weak sales figures have plagued the shares. Prana Biotechnology Limited (ADR) (NASDAQ:PRAN) have reported sales of $100,000 every year since 2012 except for 2014 when the company reported a figure of $300,000. EPS losses have been noteworthy. In 2012 the EPS loss for shares holders of PRAN was -$5.00, followed by annual EPS losses of-$6.31, -$8.55, -$3.21, and -$3.98 in 2016. There has also been consistent dilution for PRN shareholders. In 2012 the number of outstanding shares was 800,000 and that number grew annually and in 2016 the number was 1.48 million. Given Prana Biotechnology Limited (ADR) (NASDAQ:PRAN) market cap of only $23 million and its lack of sales, no analysts have reviewed the companys share ratings since 2014.
I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 96 hours. All information, or data, is provided with no guarantees of accuracy.
About the author: Marc has a degree in economics and a MSc. in Finance. Over his 20-year career, Marc has worked for global investment firms in Europe and the United States as an analyst, fund manager, and consultant.
Marc Anderson is a pseudonym. Marc has a degree in economics and a MSc. in Finance. Marc worked for global investment firms in Europe and the United States as an analyst, fund manager, and consultant. View all posts by Marcus Anderson
Excerpt from:
Prana Biotechnology Limited (ADR) (NASDAQ:PRAN) Gains are ... - StockNewsUnion
Technology and biotechnology stocks once again top our list of momentum charts to watch.
Achaogen Inc. AKAO, +7.49% had an important snapback session on Tuesday, gaining $2.12, or 9.7%, to $23.90 on over 2 million shares traded. The move came on news that venture capitalist Robert Duggan disclosed a 5.7% stake in the late-stage biopharmaceutical company. Volume was the strongest on an up-day all year, and the stock has now bounced off rising trendline support after a 10-day pullback from the top of the channel to the bottom. If the stock can get through resistance, which is now up around Tuesdays high at $24.46, it could challenge recent highs around $26.75-$27.75 on the way to the top of the channel at over $30.
Cara Therapeutics Inc. CARA, +6.08% had a nice follow-through on Tuesday, jumping 94 cents, or 5%, to $19.09, on 7.6 million shares traded. The biotech company reported positive results in a trial of a treatment for uremic pruritus, or UP. The stock reached $20.24 intraday, the highest its been since September 2015. It came down in the afternoon and didnt close great, but from the standpoint of the daily pattern as well technicals and volume, the stock looks strong. It has climbed nicely off rising trendline support toward mid-channel in the past two weeks. The stock needs to hold lateral support at around $17.50. A move through Tuesdays high could lead to $23 short-term and $27 intermediate-term.
Kopin Corp. KOPN, -0.37% maker of wearable technologies and display products, had nice action on Tuesday, especially in the afternoon when it ran from about $3.90 to $4.19, backing off a little at the close. Net on the day, it gained 8 cents, or 2%, to $4.11 on strong volume of 643,000 shares. Volume has been strong in general in the past few weeks, indicating possible accumulation, and Tuesday saw the stock edge above its breakout point at around $4.09. Watch for $4.75 and then $5-$5.25 as targets.
Nektar Therapeutics NKTR, +1.13% had a breakout session on Tuesday, up 55 cents, or 2%, to $23.93 on 1.7 million shares. The company announced on Monday it has begun dosing in a Phase 1 study of its new biologic therapy to treat auto-immune diseases and inflammatory disorders. The move broke the stock out of a week-long consolidation zone that followed its nearly 50% gap up on March 20. The move came on only average volume. Nonetheless, watch for a run at $26 short-term.
Western Digital Corp. WDC, +1.66% is on the move. Stock in the data-storage company has been up five days in a row since its March 21 close at $73.22. Investors appear to have been encouraged by Micron Technologys MU, -0.66% strong quarterly forecast late last week, and optimism about memory and storage chip demand. On Tuesday, WDC gained $1.99, or 2.5%, to $80.56, on nearly 4 million shares traded. The stock is right at a lateral resistance level, and a pop through there could get it to $86-$87 and then the channel top near $95.
See Harrys video chart analysis on these stocks.
Harry Boxer is founder of TheTechTrader.com, a live trading room featuring his stock picks, technical market analysis, and live chart presentations.
Original post:
Harry Boxer's five technology and biotechnology stocks to watch ... - MarketWatch
