Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Bayer, Bioxcel, Bristol Myers Squibb, Disc, Genentech, Geovax, Imcheck, Johnson & Johnson, Korro, Nkgen, Orion, Oruka, Promis, Redhill, Springworks.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Azurity, Concentra, Cycle, George, Handa, Iteos.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Alkermes, Alzecure, Astrazeneca, Cloudbreak, Cognition, Genentech, Ionis, Revalesio, Urogen.
In an about-face, Sarepta Therapeutics Inc. said it would “voluntarily and temporarily” pause all shipments of Duchenne muscular dystrophy gene therapy Elevidys (delandistrogene moxeparvovec) in the U.S. The move comes only a few days after the firm publicly declined a U.S. FDA request to halt shipping of the therapy in the wake of a third patient death, this one linked to a gene therapy using the same adeno-associated virus (AAV) vector as Elevidys.
Following up on the $175 million it raised in September 2023, Avalyn Pharma Inc. secured an additional $100 million in an oversubscribed series D financing round to support development of its inhaled treatments for pulmonary fibrosis.
Livzon Mabpharm Inc.’s anti-IL-17A/F monoclonal antibody, LZM-012, met the primary endpoint in a phase III trial in moderate to severe plaque psoriasis. Conducted at Fudan University’s Huashan Hospital, the phase III multicenter, randomized, double-blind, active-controlled (secukinumab) trial enrolled 926 patients with moderate to severe plaque psoriasis.
There are a raft of problems the U.S. FDA wants resolved before Replimune Group Inc.’s BLA for RP-1 (vusolimogene oderparepvec) with nivolumab to treat advanced melanoma goes any further, all of which the company said are a surprise.
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