REPL, QURE Stocks Rise Amid Makary’s Reported Resignation As FDA Chief

• The agency’s top food official, Kyle Diamantas, will serve as acting commissioner following Makary’s exit.
• Makary’s short but highly contentious tenure at the FDA was marked by frequent clashes with the pharmaceutical industry and some members of the Trump administration.
• Makary is the latest top lieutenant to leave under Health and Human Services Secretary Robert F. Kennedy Jr.

Shares of Replimune (REPL) and uniQure (QURE) jumped 7% and 5%, respectively, on Tuesday following reports that Marty Makary has resigned as commissioner of the Food and Drug Administration after weeks of mounting pressure from the Trump administration.

The New York Times reported that Makary’s departure was driven in large part by his strong opposition to the administration’s decision to authorize fruit-flavored e-cigarettes. Four people familiar with the matter told The Times that this clash played a central role in his resignation.

President Donald Trump confirmed the report in a post on Truth Social. “I want to thank Dr. Marty Makary for having done a great job at the FDA. So much was accomplished under his leadership,” Trump said, while adding that the FDA’s top food official, Kyle Diamantas, will serve as acting commissioner.  

Makary’s Tenure

Makary’s short but highly contentious tenure at the FDA, the agency responsible for regulating drugs, vaccines, medical devices, tobacco products, and much of the nation’s food supply, was marked by frequent clashes with the pharmaceutical industry and some members of the Trump administration. Makary, a former Johns Hopkins surgeon, joined the FDA in November 2024.

Makary is the latest top lieutenant to leave under Health and Human Services Secretary Robert F. Kennedy Jr., following the departures of CDC Director Susan Monarez last summer and HHS Deputy Secretary Jim O’Neill in February.

The agency’s top food official, Kyle Diamantas, will serve as acting commissioner following Makary’s exit, The New York Times reported.

Why Are REPL And QURE Stocks Rallying?

The FDA rejected Replimune’s lead melanoma therapy RP1 in a high-profile decision that drew intense industry backlash. Replimune argued the agency treated it unfairly and failed to honor prior commitments made during review meetings; the case became a flashpoint in broader criticism of Makary’s tenure.

As for uniQure, the FDA issued a sudden “key shift” in feedback in March on the company’s Huntington’s disease gene therapy AMT-130, reversing earlier assurances about the sufficiency of its Phase 1/2 data. The FDA strongly recommended a new, randomized, double-blind, sham-surgery-controlled trial, to which the company expressed disagreement.

While iShares US Pharmaceuticals ETF (IHE) rose 1.3% at the time of writing, VanEck Pharmaceutical ETF (PPH) was up nearly 2%.

How Did Retail Traders React?

On Stocktwits, retail sentiment around REPL was within ‘bullish’ territory at the time of writing, while sentiment around QURE was ‘extremely bullish.’

While REPL fell 49% over the past 12 months, QURE gained 120%. 

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