Capricor and Replimune prep for FDA adcomms, Q2 earnings roll on, Sarepta’s new leader, more

FDA advisory committee meetings are dominating the biopharma landscape, with the agency challenging the trial data for Capricor’s Duchenne muscular dystrophy therapy and questioning the sufficiency of Replimune’s single-arm study for melanoma. Meanwhile, the second-quarter earnings season is underway, highlighted by GSK’s $2.5 billion savings plan aimed at accelerating R&D and AstraZeneca’s commitment to its 2030 revenue targets. Leadership transitions continue as Sarepta appoints Michael Severino as CEO following Doug Ingram’s departure. Additionally, Amgen is mounting a rigorous defense for its rare disease drug Tavneos, requesting a formal hearing after regulatory bodies recommended withdrawal due to safety concerns. These developments underscore a period of significant regulatory scrutiny and strategic shifts across the pharmaceutical industry, further complicated by emerging intellectual property risks associated with cross-border licensing deals in China.