REPL Nosedives As FDA Chief Stands Firm Against Melanoma Treatment: ‘I Don’t Work For Replimune…’

• The FDA Commissioner reportedly clarified that the FDA made no “corrupt sweetheart deals.”
• Makary’s clarification comes on the heels of Health Secretary Robert F. Kennedy Jr. pinning the responsibility for the drug rejection on the FDA alone.
• Replimune, for its part, said that it disagrees with the FDA about the sufficiency of the dataset it submitted while also accusing the agency of inconsistent communication and a slow-moving regulatory process.

Shares of Replimune Group Inc (REPL) fell a steep 13% on Tuesday after U.S. Food and Drug Administration Commissioner Marty Makary backed the agency’s decision to refuse approval for the company’s experimental drug RP1.

FDA refused to approve Replimune’s melanoma drug RP1 for the second time in April, citing insufficient data to provide “substantial evidence of effectiveness” in the treatment of unresectable advanced cutaneous melanoma.

Makary’s Defense

“I don’t work for Replimune, I work for the American people, and I stand by the scientists at the FDA,” Makary reportedly said in an interview with CNBC’s David Faber.

The FDA commissioner also added that three independent teams arrived at the same conclusion on the drug, while putting his weight behind his review teams. The agency did not make “corrupt sweetheart deals,” he said.

“If your drug works, it’s going to get approved,” Makary said, while adding that the agency is not out to “smear any company.”

Makary’s clarification comes on the heels of Health Secretary Robert F. Kennedy Jr. pinning the responsibility for the drug rejection on the FDA alone.

Last month, the Health Secretary reportedly told a Senate hearing that he had little role in the FDA’s decision to reject RP1. "This decision comes out of FDA, and we trust ​the process there,” Kennedy reportedly said.

Medical Community Reacts

Doctors, in an opinion piece published in The Wall Street Journal last month, criticized the FDA’s decision, noting that the initial panel that reviewed RP1 had recommended approval, which was later overruled by the then-FDA biologics chief, Vinay Prasad.

The second team that reviewed the drug also did not say that the drug was ineffective, instead saying that it is “unclear whether the drug was effective,” the doctors said.

“Denying patients a life-saving medicine for inexplicable reasons is the wrong kind of change. If Dr. Makary doesn’t understand that, the FDA needs a change in leadership,” the doctors said.

Replimune Alleges Inconsistency

Replimune, for its part, said that it disagrees with the FDA about the sufficiency of the dataset it submitted while also accusing the agency of inconsistent communication and a slow-moving regulatory process.

“A treatment desperately needed by patients will not be available. Not because the medicine failed. Because the system did,” Replimune CEO Sushil Patel said.

Replimune’s Efforts With RP1 Approval

In late July 2025, the FDA issued a complete response letter regarding the company’s application for RP1 in combination with Nivolumab for the treatment of advanced melanoma.

The agency said in the letter that it is unable to approve the application in its present form, and indicated that the trial conducted by the company for the drug is not considered to be an adequate and well-controlled clinical investigation that provides substantial evidence of effectiveness. It further urged that the company conduct and provide the results from a fresh trial for further consideration.

Replimune subsequently resubmitted its application in October with additional information and analyses, but no additional trial.

In April, the FDA said that the revised application does not alter its initial conclusion of the ineffectiveness of the trials conducted by the company.

Replimune can either resubmit or withdraw its application within a year, the agency said.

How Did Retail Traders React?

On Stocktwits, retail sentiment around REPL stock stayed within the ‘bullish’ territory over the past 24 hours, while message volume stayed within ‘extremely low’ levels.

A Stocktwits user said that the company is “done.”

Another highlighted that the agency will not move on its decision for RP1.

A third user highlighted that the FDA commissioner does not seem “happy” with how REPL handled the rejection.

REPL stock is down 74% over the past 12 months. 

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