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The Daily Biotech Pulse: FDA Nod For Amgen's Biosimilar, Moderna's Vaccine Vote, Mesoblast Sinks On Data

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The Daily Biotech Pulse: FDA Nod For Amgen's Biosimilar, Moderna's Vaccine Vote, Mesoblast Sinks On Data

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

Scaling The Peaks

(Biotech Stocks Hitting 52-week Highs Dec. 17)

  • Acceleron Pharma Inc (NASDAQ: XLRN)
  • Alexion Pharmaceuticals, Inc. (NASDAQ: ALXN)
  • AtriCure Inc. (NASDAQ: ATRC)
  • Avanos Medical Inc (NYSE: AVNS)
  • Bioanalytical Systems, Inc. (NASDAQ: BASI)
  • BioLife Solutions Inc (NASDAQ: BLFS)
  • BridgeBio Pharma Inc (NASDAQ: BBIO)
  • Castle Biosciences Inc (NASDAQ: CSTL)
  • Certara Ord Shs (NASDAQ: CERT)
  • Chimerix Inc (NASDAQ: CMRX)
  • Corcept Therapeutics Incorporated (NASDAQ: CORT)
  • Chinook Therapeutics Inc (NASDAQ: KDNY)
  • Clearpoint Neuro Inc (NASDAQ: CLPT)
  • Corcept Therapeutics Incorporated (NASDAQ: CORT)
  • Denali Therapeutics Inc (NASDAQ: DNLI)
  • Eli Lilly And Co (NYSE: LLY)
  • Eidos Therapeutics Inc (NASDAQ: EIDX)
  • Foghorn Therapeutics Inc. (NASDAQ: FHTX)
  • Frequency Therapeutics Inc (NASDAQ: FREQ)
  • Genmab 10 Sponsored ADR Ord Shs (NASDAQ: GMAB)
  • Glaukos Corp (NYSE: GKOS)
  • Inhibrx Inc (NASDAQ: INBX)
  • Integra Lifesciences Holdings Corp (NASDAQ: IART)
  • Kiromic Biopharma Inc (NASDAQ: KRBP) (announced submission of two IND applications to the FDA)
  • MannKind Corporation (NASDAQ: MNKD)
  • Medpace Holdings Inc (NASDAQ: MEDP)
  • MiMedx Group Inc (NASDAQ: MDXG)
  • NeoGenomics, Inc. (NASDAQ: NEO)
  • Nevro Corp (NYSE: NVRO)
  • Nkarta Inc (NASDAQ: NKTX)
  • Oncorus Inc (NASDAQ: ONCR)
  • OncoSec Medical Inc (NASDAQ: ONCS)
  • Organogenesis Holdings Inc (NASDAQ: ORGO)
  • Otonomy Inc (NASDAQ: OTIC) (announced positive results for Phase 1/2 study of therapy to treat hearing loss)
  • PRA Health Sciences Inc (NASDAQ: PRAH)
  • Prelude Therapeutics Inc (NASDAQ: PRLD)
  • Prevail Therapeutics Inc (NASDAQ: PRVL)
  • Sanara Medtech Inc (NASDAQ: SMTI)
  • Scopus Biopharma Inc (NASDAQ: SCPS)
  • SI-Bone Inc (NASDAQ: SIBN)
  • Silverback Therapeutics Inc (NASDAQ: SBTX
  • Solid Biosciences Inc (NASDAQ: SLDB)
  • Spero Therapeutics Inc (NASDAQ: SPRO) (announced appointment of a new CFO)
  • SpringWorks Therapeutics Inc (NASDAQ: SWTX)
  • Stoke Therapeutics Inc (NASDAQ: STOK)
  • Summit Therapeutics Inc (NASDAQ: SMMT)
  • Tarsus Pharmaceuticals Inc (NASDAQ: TARS)
  • Ultragenyx Pharmaceutical Inc (NASDAQ: RARE)
  • X T L Biopharmaceuticals Ltd (NASDAQ: XTLB)
  • Zai Lab Ltd – ADR (NASDAQ: ZLAB) ( reacted to FDA approval for partner MacroGenics Inc's (NASDAQ: MGNX) breast cancer therapy)

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows Dec. 16)

  • Galapagos ADR Representing Ord Shs (NASDAQ: GLPG)
  • Histogen Inc (NASDAQ: HSTO) (announced filing of an IND for HST-003 for knee cartilage regeneration)
  • InMed Pharmaceuticals Inc (NASDAQ: INM)
  • Olema Pharmaceuticals Inc (NASDAQ: OLMA)
  • Sonnet BioTherapeutics Holdings, Inc. (NASDAQ: SONN) (reacted to its fiscal-year 2020 results)

Stocks In Focus

Mereo Out-licenses Brittle Bone Disease Drug to Ultragenyx For Up to $304M

Mereo BioPharma Group (NASDAQ: MREO) and Ultragenyx announced a license and collaboration agreement for setrusumab, a monoclonal antibody in clinical development for osteogenesis imperfecta.

The agreement provides for Ulltragenyx leading future global development of setrusumab in both pediatric and adult patients, and commercializing it in the U.S. and rest of the world, excluding Europe, Mereo retains commercial rights for Europe.

Ultragenyx will make an upfront payment of $50 million to Mereo and a total of up to $254 million upon achievement of certain clinical, regulatory, and commercial milestones. Ultragenyx will pay tiered double-digit percentage royalties to Mereo on net sales outside of Europe, and Mereo will pay a fixed double digit percentage royalty to Ultragenyx on net sales in Europe.

In after-hours trading, Mereo shares jumped 39.37% to $3.08.

Mesoblast's Stem Cell Therapy Unlikely to Achieve Primary Endpoint In COVID-19 Study

Mesoblast (NASDAQ: MESO) said Data Safety Monitoring Board that performed a third interim analysis of data from a study of remestemcel-L in ventilator-dependent patients with moderate to severe acute respiratory distress syndrome due to COVID-19 infection said the trial is not likely to meet the 30-day mortality reduction endpoint at the planned 300 patient enrolment. The committee recommended that the trial complete with the currently enrolled 223 patients, and that all be followed-up as planned.

The committee, however, said there are no safety concerns.

Mesoblast, which is partnering with Novartis AG (NYSE: NVS) in the program, said both companies plan to analyze these results to identify meaningful clinical outcomes that may guide decisions on the development program for remestemcel-L in non-COVID ARDS.

The stock slumped 31.83% to $9.25 in after-hours trading.

Moderna's Vaccine Candidate Endorsed By FDA Panel

Moderna (NASDAQ: MRNA) said the FDA's Vaccines and Related Biological Products Advisory Committee recommended that the regulator grant an emergency use authorization for its investigational vaccine, mRNA-1273, with a 20-0 vote. One member abstained from voting.

Vir, GlaxoSmithKline Commence Phase 3 Trial of Antibody Treatment For COVID-19

Vir Biotechnology Inc (NASDAQ: VIR) and GlaxoSmithKline plc (NYSE: GSK) announced that the first patient has been dosed in a new sub-trial of NIH-sponsored Phase 3 trial that is evaluating the safety and efficacy of VIR-7831 for the treatment of hospitalized adults with COVID-19. VIR-7831 is a fully human anti-SARS-CoV-2 investigational monoclonal antibody that was selected based on its potential to neutralize the virus, kill infected cells, provide a high barrier to resistance and achieve high concentrations in the lungs.

FDA Approves Amgen's Rituxan Biosimilar

Amgen, Inc. (NASDAQ: AMGN) said the FDA approved Riabni, a biosimilar to Roche Holdings AG's (OTC: RHHBY) Rituxan, for the treatment of adult patients with non-Hodgkin's lymphoma, chronic lymphocytic leukemia, granulomatosis with polyangiitis, and microscopic polyangiitis. Riabni will be made available in the U.S. in January 2021.

Mannkind Announces Co-promotion Agreement For Hypothyroidism Enzyme Replacement Therapy

Mannkind and Vertice Pharma announced that they have entered into a co-promotion agreement for Thyquidity oral solution through MannKind's specialty sales force. Thyquidity is indicated as a replacement therapy in primary, secondary, and tertiary congenital or acquired hypothyroidism.

Under the terms of the agreement, MannKind's sales force will promote Thyquidity, and Vertice will pay Mannkind a specified quarterly to defray the costs of the additional promotional activity as well as royalties on gross profit resulting from all sales of Thyquidity.

Mannkind shares were up 2.48% to $4.14 in premarket trading.

Oyster Point Submits Regulatory Filing For Dry Eye Disease Drug

Oyster Point Pharma Inc (NASDAQ: OYST) said it has submitted a 505(b)(2) NDA to the FDA for OC-01 (varenicline) nasal spray for the treatment of signs and symptoms of dry eye disease.

BioTelemetry to Be Bought By Philips For $72/Share

BioTelemetry Inc (NASDAQ: BEAT) announced a deal to be acquired by Royal Philips for $72.00 per share, implying an enterprise value of $2.8 billion.

In premarket trading Friday, BioTelemetry shares were rallying 18.16% to $73.

Offerings

Vistagen Therapeutics Inc (NASDAQ: VTGN) said it has priced its underwritten public offering consisting of 63 million shares of its common stock at a price of 92 cents per share, and 2 million shares of its Series D convertible preferred stock at $21.16 per share. The company expects to raise $100 million in gross proceeds from the offerings.

The stock was rising 6.95% to 99 cents in premarket trading Friday.

On The Radar

Clinical Readouts

CNS Pharmaceuticals Inc (NASDAQ: CNSP) is scheduled to discuss on a conference call, investigational new drug approval for its lead product candidate, Berubicin, for the treatment of glioblastoma multiforme, and the planned Phase 2 Berubicin clinical trial.

Related Link: Attention Biotech Investors: Mark Your Calendar For December PDUFA Dates

 

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