Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Arcutis, CSL, Genentech, GSK, Roche, Soleno, Springworks, Xbrane.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Bicara, Gilead, Gyre, Immix, Imunon, Innate, Merus, Roche.
A former board member of Chinook Therapeutics Inc. and four others were charged May 22 in a 19-count indictment stemming from an alleged insider trading scheme that produced more than $600,000 in profits after the June 2023 announcement that Novartis AG was acquiring the Seattle-based Chinook in a $3.5 billion deal.
BioWorld recorded 151 clinical trial updates from phases I through III in April 2025, a drop from 197 in March. The month saw 13 successful phase III readouts, alongside four failed trials and two with mixed results.
History has repeated itself for Prothena Corp. plc, which has reported a second phase III miss for birtamimab in the treatment of light chain amyloidosis. Announcing the trial failure, the Dublin-based company said it is planning “a substantial reduction” of its organization.
Rocket Pharmaceuticals Inc. CEO Gaurav Shah said his firm is investigating how its gene therapy for Danon disease may have created an “unexpected and paradoxical” effect that led to problems for a phase II patient who ultimately died.
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