The Daily Biotech Pulse: Mesoblast To Test Candidate On Coronavirus Symptoms, Proxy Battle Ahead For Rockwell Medical, Glaukos to Join S&P SmallCap 600 Index

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

Stocks In Focus

Mesoblast Plans To Evaluate Stem Cell Therapy Candidate For Coronavirus Respiratory Distress 

Mesoblast limited 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 To Provide Manufacturing Support For Novavax's COVID-19 Program

Emergent Biosolutions Inc EBS said it has entered into an agreement with Novavax, Inc. NVAX, under which the former will use its molecule-to-market contract development and manufacturing service to support bringing into the 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 anticipates commencement 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 Appoints Anthony Mancini As Chief Operating Officer

GENMAB A/S/S ADR GMAB announced the appointment of Anthony Mancini as EVP and COO effective March 23. Mancini's role calls for him to oversee the company's commercial, corporate development, business development and information technology functions.

Glaukos Set To Join S&P SmallCap 600 Index

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 AKS, which has agreed to be acquired by Cleveland-Cliffs Inc CLF.

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

MediciNova Plans Clinical Study Of Ibudilast In Pneumonia, Acute Respiratory Distress Syndrome

MediciNova, Inc. 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.

Rockwell Medical Faces Pressure From Activist Investor

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

The investment firm said Rockwell's board has failed to provide appropriate governance, resulting in reckless spending, a cash 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 Discontinues Midstage Neurological Disorder Drug Study

Acceleron Pharma Inc XLRN said treatment with ACE-083 in patients with Charcot-Marie-Tooth disease did not demonstrate functional improvement in a Phase 2 trial.

The company said it is discontinuing the development of ACE-083.

Earnings

Organogenesis Holdings Inc's 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 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 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 $42.6 million 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.

On The Radar

PDUFA Dates

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

Earnings

• Precision BioSciences Inc DTIL (before the market open)
• Akebia Therapeutics Inc AKBA (before the market open)
• Catabasis Pharmaceuticals Inc CATB (before the market open)
• InspireMD Inc NSPR (before the market open)
• ChemoCentryx Inc CCXI (after the close)
• CV Sciences Inc CVSI (after the close)
• Fulgent Genetics Inc FLGT (after the close)
• Sunesis Pharmaceuticals, Inc. SNSS (after the close)
• RA Medical Systems Inc RMED (after the close)
• Protagonist Therapeutics Inc PTGX (after the close)
• Castle Biosciences Inc CSTL (after the close)
• Constellation Pharmaceuticals Inc CNST (after the close)

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