Novartis AG didn’t say why the FDA has put off action until September – a delay of three months – on the sBLA for multiple sclerosis (MS) prospect Arzerra (ofatumumab, OMB-157), first cleared in October 2009 for chronic lymphocytic leukemia, but the holdup brought renewed attention to the bustling space, and Immunic Inc. – which held its R&D Day on May 27 – is coming on strong.
Shares of Cymabay Therapeutics Inc. (NASAQ:CBAY) shot 37% higher on Monday after top-line data showed 78.2% of people with primary biliary cholangitis (PBC) in the company's disrupted phase III test of seladelpar achieved the primary composite outcome after just three months on a 10-mg dose of the drug vs. 12.5% in the trial’s placebo arm.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Arcutis, Baudax, Endo, Highlight, Horizon, Ico, Pfizer.
HONG KONG – Suwon-based Olix Pharmaceuticals Inc. is completing the final preclinical work before starting clinical trials for its as-yet-unnamed COVID-19 drug candidate, developed inside three months using RNA interference (RNAi) technology.
By filing an IND with the FDA to initiate a phase II/III study of EB-05, a monoclonal antibody, Edesa Biotech Inc. joined the handful of companies developing COVID-19 treatments that inhibit Toll-like receptor 4 (TLR4) signaling. The Toronto-based company’s stock (NASDAQ:EDSA) responded by rocketing 81.38% upward Thursday to close at $9.45, after trading as high as $19.10.
Unraveling the eagerly awaited data from Genocea Biosciences Inc.’s phase I/IIa study with neoantigen cancer vaccine GEN-009 turned out less than simple, and the rollout of results – characterized by the company as positive, albeit early – were followed by a haircut for shares (NASDAQ:GNCA), which closed at $3.45, down $1.52, or 31%.
Like many companies, New York-based Abeona Therapeutics Inc. faltered clinically as a result of the COVID-19 virus, which delayed enrollment in the phase III study with EB-101 gene therapy in recessive dystrophic epidermolysis bullosa (RDEB), but the company earlier this month disclosed the restart of patient enrollment in the experiment called Viital.
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