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Investing.com -- Replimune Group Inc (NASDAQ:REPL) stock tumbled 36% premarket after STAT reported that the FDA’s top cancer drug regulator intervened late in the review process of the company’s skin cancer therapy, contributing to its rejection despite support from others within the agency.
According to information obtained by STAT from three FDA officials with direct knowledge of the matter, the regulator’s intervention in the review of Replimune’s drug, known as RP1, played a key role in the treatment’s last-minute denial. The report indicates that internal support existed for the therapy within the FDA before the senior official stepped in.
The rejection occurred amid broader turmoil at the FDA, which has been experiencing leadership changes, staff upheaval, and internal dysfunction. These organizational issues reportedly factored into the review process and ultimate rejection decision, with Replimune caught in the crossfire.
The STAT report clarified that Vinay Prasad, who has been criticized for taking a hard line in reviews before his departure from the agency, did not play a substantive role in the debate over Replimune’s therapy.
The revelation about mixed views within the FDA regarding RP1’s approval provides new context for investors who were already aware of the drug’s rejection but not the internal disagreement surrounding the decision.
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