Why did FDA Commissioner Dr. Marty Makary resign, and what immediate market reaction followed?

Dr. Marty Makary resigned as FDA Commissioner amid weeks of pressure from powerful Republicans and anti-abortion groups over controversial agency decisions on drug approvals. His departure triggered an initial positive market reaction: the Nasdaq biotechnology index (.NBI) closed up 1% on Tuesday, and shares of companies previously in public spats with Makary—uniQure (up 5%) and Replimune (up nearly 10% on Tuesday, then ~28% more on Wednesday afternoon)—rose sharply.

Who is leading the FDA temporarily, and what concerns do analysts have about the leadership vacuum?

Deputy Commissioner for Food Kyle Diamantas will lead the FDA in an acting capacity, while former commissioners Steve Hahn and Brett Giroir are among those under consideration for the permanent role. Analysts warn that a prolonged leadership vacuum—especially with the two top drug oversight positions already held by acting officials—will likely cause 'more delays and unpredictability' at the FDA, undermining its ability to provide guidance or make credible policy commitments, and challenging 'investability across the biopharma ecosystem.'

Makary exit may temporarily lift biotech sentiment but FDA leadership vacuum looms

May 13, 2026

FDA Commissioner Dr. Marty Makary resigned amid political pressure, triggering an initial biotech rally. Analysts warn the leadership vacuum may delay drug approvals and increase market volatility.

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