Replimune Group (NASDAQ:REPL) saw its stock gain 15% on Wednesday after Health Secretary Robert F. Kennedy Jr. told a Senate hearing that he had no role in the Food and Drug Administration’s decision to withhold approval for the company’s cancer therapy, RP1.
Speaking at a hearing convened to review President Donald Trump’s fiscal 2027 budget for the Department of Health and Human Services, Kennedy said the matter was handled by the FDA and that agency Commissioner Dr. Marty Makary was overseeing the review. According to Kennedy, Makary informed him that the panels evaluating the drug had unanimously voted against approval on the basis that RP1 did not appear to be effective.
Earlier this month the FDA declined to approve RP1, taking particular issue with Replimune’s reliance on a single-arm study without a control group. In its rejection letter, the agency said the company must provide evidence from a well-controlled trial that demonstrates adequate effectiveness.
Replimune’s shares have been under pressure since the latest rejection, falling nearly 70% since the FDA turned down the drug for the second time in two years. The stock’s move to the upside on Wednesday followed an opinion piece published late Tuesday in The Wall Street Journal that disputed Kennedy’s account. That opinion column said Kennedy’s statements were not accurate and directed criticism toward Vinay Prasad, the head of the FDA drug center, who had said last month he would be leaving the agency in April.
Context and immediate developments
Kennedy’s comments at the Senate hearing framed the FDA decision as an internal regulatory matter, attributing the outcome to FDA panels and leadership. The agency’s stated reason for withholding approval focused on the study design used to support RP1’s effectiveness, specifically calling for data from a well-controlled trial.
Market reaction
Investors bid Replimune shares higher following the public exchange of statements and the opinion piece that called into question the Health Secretary’s account. The stock’s intraday rise occurred against the backdrop of the company’s longer-term decline after the repeated FDA rejections.
Limitations of available information
The record presented at the hearing and in subsequent media coverage reflects statements by public officials and the FDA’s written rejection. The article does not include additional independent data about RP1 beyond the FDA’s stated concerns about trial design, and it does not provide further detail on planned next steps by Replimune or the agency.