REPL, QURE, MRNA Soar On Reports Trump Will Fire FDA’s Marty Makary

• The plans come on the heels of several complaints from the pharmaceutical industry and sparring with others in the health department over policy, the report added.
• Makary, a former Johns Hopkins surgeon, joined the FDA in November 2024.
• Shares of REPL and QURE jumped as much 17% following the report.

President Donald Trump is reportedly considering firing U.S. Food and Drug Administration Commissioner Marty Makary.

The Wall Street Journal reported on the plans on Friday, citing people familiar with the matter, while noting that other top administration officials believe Makary is struggling to manage his agency. The plans come on the heels of several complaints from the pharmaceutical industry and sparring with others in the health department over policy, the report added.

However, the president’s plans are not final and could change, the report said. WSJ noted that Makary, if fired, would become the latest top lieutenant to be fired 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.

Makary, a former Johns Hopkins surgeon, joined the FDA in November 2024.

Companies Likely To Benefit from Makary’s Exit

Several biotech and pharmaceutical firms that have publicly clashed with the Makary-led FDA over what they describe as inconsistent, unpredictable, or overly restrictive drug-review processes are viewed as potential beneficiaries of new leadership that could accelerate approvals and restore clearer regulatory guidance.

Replimune Group Inc. (REPL): The FDA rejected the company’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.

uniQure N.V. (QURE): The agency issued a sudden “key shift” in feedback 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.

Moderna Inc. (MRNA): CEO Stéphane Bancel publicly stated that the FDA under Makary had become “unpredictable” in a way that “threatens U.S. leadership in innovative medicines.” The company experienced surprise setbacks, including an initial refusal to accept a flu vaccine application that was later reversed.

Regenxbio Inc. (RGNX): The FDA declined to approve the company’s gene therapy for the ultra-rare Hunter syndrome (MPS II) in February 2026, despite prior engagement. Industry observers cited this as part of a pattern of moving goalposts that has frustrated rare-disease developers.

Sarepta Therapeutics Inc. (SRPT): Sarepta faced repeated conflicts over its Duchenne muscular dystrophy gene therapy Elevidys, including safety and efficacy disputes under Makary’s oversight and the influence of former FDA official Vinay Prasad.

Other biotech stocks likely to benefit from under new FDA leadership include Hims & Hers Health (HIMS), which faced direct public criticism from Makary over its compounded GLP-1 weight-loss products, and rare-disease gene- and RNA-therapy developers such as Dyne Therapeutics (DYN), Avidity Biosciences (RNA), and Lexeo Therapeutics (LXEO), all of which have cited inconsistent feedback and delays during Makary’s tenure.

Shares of REPL jumped 17% at the time of writing, while QURE rose 15%. MRNA traded 10% higher, while SRPT stock traded 3% lower, and RGNX shares stayed flat.

How Did Retail Traders React?

A Stocktwits user voiced optimism for eventual approval of Replimune’s RP-1 drug, calling the decision to deny it approval a “terrible one.”

Another voiced optimism for “someone better” replacing Makary.

While REPL shares fell by about 50% over the past 12 months, QURE rose 124%. 

Read More: LCID-UBER Partnership Accelerates After Nuro Lands Key California Permit for Gravity Robotaxis

For updates and corrections, email newsroom[at]stocktwits[dot]com.