Several drugmakers took hits this week as regulators, investors and boards all applied pressure at once.
Sarepta Therapeutics named Mike Severino its new chief executive. According to BioPharma Dive, Severino is a former AbbVie executive who most recently led the startup Tessera Therapeutics, and he inherits a company dealing with emerging competition and falling sales for Elevidys, its prized gene therapy. Gene therapies are among the industry's most expensive and closely watched products, so a slump there is a serious problem, not a rounding error.
Regulatory scrutiny hit Capricor. BioPharma Dive reported that FDA scientists questioned the company's data ahead of a high-stakes advisory committee meeting, and Capricor shares lost much of their value in the run-up. Advisory committees are outside expert panels that weigh in before the FDA decides on approval — a skeptical agency review going in is a bad sign.
The same BioPharma Dive roundup noted that Legend's stock slide deepened after CEO Ying Huang resigned, and that AstraZeneca disclosed more pipeline trouble.
MapLight Therapeutics offered the sharpest single-day pain. Endpoints News reported the stock fell more than 60% on Monday after a once-daily version of its schizophrenia drug missed the trial's main goal in a mid-stage study — even though the study succeeded overall. Investors had been counting on the once-daily option, which is easier for patients to stick with.
Not everything was grim. Endpoints also reported that the FDA approved Otsuka's ADHD pill, and that Yarrow Bioscience, led by CEO Rebecca Frey, closed a merger to go public while developing an anti-TSHR antibody for Graves' disease and thyroid eye disease.
Why it matters: when regulators push back and trial results disappoint, the money and management churn that follows shapes which medicines actually reach patients.