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.
A bioelectronic platform that stimulates the vagus nerve to reduce inflammatory activity and restore balance in the immune system is the ultimate aim of Setpoint Medical Inc. The Valencia, Calif.-based startup is preparing to start a U.S. pivotal trial for its most advanced program in rheumatoid arthritis (RA) later this year or early next.
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.
More than 70% of individuals using Big Health’s newest digital therapeutic, Daylight, achieved remission of generalized anxiety disorder (GAD) within 10 weeks, and the benefit persisted for at least six months, according to results published in Depression and Anxiety.
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%.
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