Biotech stocks rise as FDA chief Makary exits, but leadership uncertainty threatens sector

U.S. biotech shares gained after President Donald Trump said on May 12, 2026, that FDA Commissioner Dr. Marty Makary would leave the agency, easing investor concerns after a series of contentious drug-review decisions. The Nasdaq Biotechnology Index closed up 1% on May 12. Trump said Deputy Commissioner for Food Kyle Diamantas will serve as acting FDA chief. Reuters reported on May 08 that former FDA Commissioner Steve Hahn and former acting commissioner Brett Giroir are among candidates being considered for the permanent role. Analysts warned that a prolonged leadership gap could increase delays and regulatory uncertainty, especially with the FDA’s two top drug-oversight posts also held by acting officials. Truist said the resignation may prompt a short-term positive reaction but could weaken the agency’s ability to provide guidance. RBC’s Brian Abrahams said unstable leadership challenges biopharma investability. Shares of uniQure rose 5% and Replimune gained nearly 10% on May 12; Replimune rose about 28% in afternoon trading on May 13.