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Here's a roundup of top developments in the biotech space over the last 24 hours.
(Biotech Stocks Hitting 52-week Highs Dec. 17)
(Biotech Stocks Hitting 52-week Lows Dec. 16)
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 (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 (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 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.
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 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 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 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.
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.
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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