REPL Ignites On Doctor Fury Against FDA’s Melanoma Drug Snub — Health Sec Steps Back

• FDA refused to approve Replimune’s melanoma drug RP1 for the second time earlier this month, citing insufficient data to provide “substantial evidence of effectiveness.”
• Doctors also called for a change in leadership at the FDA over its decision not to approve Replimune’s RP1. 
• According to a report from Reuters, Health Secretary Robert F. Kennedy Jr. told a Senate hearing on Wednesday that he had little role in the FDA’s decision to reject RP1.

Shares of Replimune (REPL) jumped 22% on Wednesday after doctors who treat melanoma expressed disappointment over the U.S. Food and Drug Administration’s rejection of the company’s experimental drug RP1.

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

Doctors, in an opinion piece published in The Wall Street Journal, 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. Melanoma doctors organized and sent a letter to the FDA imploring it to approve RP1, they noted, while adding that they weren't asked by the pharma industry to do it.

“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.

Kennedy Distances Self

According to a report from Reuters, Health Secretary Robert F. Kennedy Jr. told a Senate hearing on Wednesday that he had little role in the FDA’s decision to reject R1.

He, instead, said that the decision was in the hands of FDA Commissioner Marty Makary.

"This decision comes out of FDA, and we trust ​the process there,” Kennedy reportedly said.

Replimune’s Efforts With RP1 Approval

In late July 2025, the FDA had 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 then 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.

Earlier this month, the FDA said that the revised application does not alter its initial conclusion of the ineffectiveness of the trials conducted by the company. The agency also noted that the members of the team who reviewed the resubmission were different from those who reviewed the initial application to maintain objectivity.

Replimune can either resubmit or withdraw its application within a year.

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 opined that “REPL is done for the next two years” and added that the company needs a lifeline from another company.

Another user reiterated confidence in the FDA’s decision to reject the drug.

Another user, however, said that they are looking for 30X gains on REPL stock.

REPL stock has fallen 74% over the past 12 months. 

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