StemCell Therapy

Here's a roundup of top developments in the biotech space over the last 24 hours:

(Biotech stocks that hit 52-week highsMarch 9.)

(Biotech stocks that hit 52-week lows March 9.)

See also:Attention Biotech Investors: Mark Your Calendar For These March PDUFA Dates

Mesoblast limited (NASDAQ: MESO) said it plans to evaluate its allogenic mesenchymal stem cell product candidate remestemcel-L in patients with acute respiratory distress syndrome caused by COVID-19 in the U.S., Australia, China and Europe.

The company said it is in active discussions with various government and regulatory authorities, medical institutions and pharma companies.

In premarket trading Tuesday, the shares were surging 28.35% to $7.90.

Emergent Biosolutions Inc (NYSE: EBS) said it has entered into an agreement with Novavax, Inc. (NASDAQ: NVAX), under which the former will use its molecule-to-market contract development and manufacturing service to support bringing intothe latter's vaccine candidate to protect against COVID-19 into the clinic.

Emergent will produce the COVID-19 experimental vaccine candidate developed using Novavax's proprietary recombinant protein nanoparticle technology platform. Emergent said it has initiated work and anticipatescommencement of a Phase 1 study within the next four months.

Separately, Novavax said the Coalition for Epidemic Preparedness awarded it an initial funding of $4 million to support its COVID-19 vaccine program.

In premarket trading Tuesday, Emergent shares were adding 0.95% to $53.02 and Novavax shares were surging up 24.35% to $12.46.

GENMAB A/S/S ADR (NASDAQ: GMAB) announced the appointment of Anthony Mancini as EVP and COOeffective March 23. Mancini's rolecalls for himto oversee the company's commercial, corporate development, business development and information technology functions.

Ophthalmic medtech and pharma company Glaukos is set to join the S&P SmallCap 600 Index, effective prior to the open of trading March 13, replacing AK Steel Holding Corporation (NYSE: AKS), which has agreed to be acquired by Cleveland-Cliffs Inc (NYSE: CLF).

Glaukos shares were trading 7.5% higher at $38.49 in the premarket session.

MediciNova, Inc. (NASDAQ: MNOV) said it plans to initiate the development of MN-166 for severe pneumonia and acute respiratory distress syndrome following positive results in a recent preclinical study in an animal model. The animal study showed treatment with the investigational candidate reversed histological changes, including inflammation, hemorrhage, alveolar congestion and alveolar edema.

Medical Resources Acquisition said on Feb. 25 it offered Rockwell Medical Inc (NASDAQ: RMTI) $15 million in equity investment for three board seatscurrently held by John Cooper, Mark Ravich and Lisa Colleran.

The investment firm said Rockwell's board hasfailed to provide appropriate governance, resulting in reckless spending, acash deficiency and a lack of operational controls that have impacted stock performance.

Rockwell acknowledged receiving an email from Medical Resources Acquisition in a press release.

"The Board of Directors is in the process of reviewing the materials submitted by MRAG. Stockholders do not need to take any action at this time," the company said.

The stock was trading 9.37% higher at $3.50 in Tuesday's premarket session.

Acceleron Pharma Inc (NASDAQ: XLRN) saidtreatment with ACE-083 in patients with Charcot-Marie-Tooth disease did not demonstrate functional improvement in aPhase 2 trial.

The companysaid it is discontinuing the development of ACE-083.

Organogenesis Holdings Inc's (NASDAQ: ORGO) fourth-quarter revenues climbed 17% to $74.6 million. The net loss per share narrowed from 12 cents to 4 cents. For 2020, the company guided to revenues of $273 million to $277 million. The results as well as the guidance were above consensus.

The stock jumped 14.56% to $3.54 in after-hours trading.

Aduro BioTech Inc (NASDAQ: ADRO) said its fourth-quarter revenues increased from $2.8 million in 2018 to $3.6 million in 2019. The loss per share narrowed from 33 cents to 24 cents, while analysts expected a narrower loss of 21 cents per share.

The stock slipped 4.89% to $2.92 in after-hours trading.

Assertio Therapeutics Inc (NASDAQ: ASRT) reported fourth-quarter revenues of $59.23 million and a loss of $2.65 per share. In the year-ago quarter, the company reported revenues of $42.6million and a loss of 38 cents per share. On a non-GAAP basis, the company reported a loss of 14 cents per share for the recent quarter compared to expectations for a profit of 14 cents per share.

The stock fell 11.21% to 95 cents in after-hours trading.

The FDA is set to rule on Bristol-Myers Squibb Co's (NYSE: BMY) sBLA for Opdivo + Yervoy as treatment option for patients with advanced hepatocellular carcinoma who werepreviously treated with Bayer AG (OTC: BAYRY) and Onyx Pharma's Nexavar.

Related Link: The Week Ahead In Biotech (March 8-14): Bristol-Myers Awaits FDA Nod For Liver Cancer Combo Therapy, Earnings Flow Continues

2020 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.

See the original post:
The Daily Biotech Pulse: Mesoblast To Test Candidate On Coronavirus Symptoms, Proxy Battle Ahead For Rockwell Medical, Glaukos to Join S&P SmallCap...

This entry was posted on March 12, 2020 at 8:50 am and is filed under Biotechnology. You can follow any responses to this entry through the RSS 2.0 feed. Both comments and pings are currently closed. |