Janssen Pharmaceutical Cos, Inc.’s CAR T-cell therapy, Carvykti (ciltacabtagene autoleucel), looks set for approval in Europe after endorsement by regulators for advanced multiple myeloma. At its monthly meeting, the EMA’s Committee for Medicinal Products for Human Use recommended Carvykti for adults with relapsed and refractory disease who have received at least three prior therapies and whose cancer has worsened since their last treatment. Read More
The beleaguered PI3K-delta inhibitor space took another blow after MEI Pharma Inc. and partner Kyowa Kirin Co. Ltd. said the U.S. FDA won’t greenlight zandelisib without data from a randomized study. The firms had hoped to win accelerated approval in relapsed/refractory follicular lymphoma and marginal zone lymphoma based on a single-arm phase II study called Tidal. Read More
Top-line interim phase I/II data from Icosavax Inc.’s virus-like particle COVID-19 vaccine fell short of company and market expectations. IVX-411, which displays the SARS-CoV-2 receptor binding domain, was found to be immunogenic and well-tolerated, but the level of immune response was lower than anticipated and inconsistent with data on Icosavax’s platform and its preclinical results. Read More
AN2 Therapeutics Inc., a company developing a once-daily treatment for people with chronic non-tuberculous mycobacterial lung disease, raised $69 million in an upsized IPO. The offering of 4.6 million shares (NASDAQ:ANTX), initially priced at $15 each, met a modest market reception, with shares rising to $15.40 by market close on March 25. The Menlo Park, Calif.-based company is developing epetraborole, a boron-containing small-molecule inhibitor of bacterial leucyl-tRNA synthetase, in-licensed from Anacor Pharmaceuticals Inc., now part of Pfizer Inc. Read More
Moonlake Therapeutics AG is making headway on its mission to establish a broad dermatology and rheumatology franchise around its sole product, sonelokimab, announcing it is poised to start a phase II study in hidradenitis suppurativa. Read More
Jiangsu Atom Bioscience and Pharmaceutical Co. Ltd., a company developing an oral a urate anion exchanger 1 inhibitor for the potential treatment of chronic gout, said results of a phase IIa trial show that its lead candidate, ABP-671, reduced serum uric acid levels to less than 6 mg/dL, below the clinically defined threshold of 7 mg/dL for hyperuricemia, or excess of uric acid in the blood, which leads to gout. Read More
SK Biopharmaceuticals Co. Ltd.'s three-pronged plan for tackling epilepsy is going strong, with lead drug cenobamate for drug-resistant focal-onset seizures nearing the finish line, and earlier-stage programs for a mRNA-based approach and a digital therapeutic in the works. Read More
Researchers at the University of Minnesota have identified a nonhormonal form of contraception for males, which left male mice temporarily sterile after a few weeks of administration. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Astrazeneca, Clarity, Freeline, Jazz, Moonlake, Mydecine, Oncolytics, Protara, Revelation, Saniona. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Arrowhead, Azafaros, Eli Lilly, Fennec, Fluoguide, Innovent, Pfizer, Viiv. Read More
