Shares of Replimune Group Inc. (NASDAQ:REPL) plunged 36% in premarket trading after a report revealed new details about the internal dynamics behind the FDA’s rejection of its skin cancer treatment, RP1. The report, published by STAT, suggested that a high-ranking FDA cancer drug official stepped in late during the review process and influenced the decision—despite earlier support from others inside the agency.
According to three FDA officials who spoke to STAT, there was momentum within the agency to approve Replimune’s RP1 therapy before the intervention by the senior regulator. This last-minute change in position was cited as a key reason the drug did not receive approval.
The setback for Replimune came amid a broader period of disruption at the FDA, which has been undergoing leadership transitions, staff turnover, and internal tensions. These organizational challenges reportedly played into the way RP1’s review unfolded, potentially contributing to the therapy’s rejection.
The STAT report also clarified that Vinay Prasad, a figure who had previously drawn criticism for adopting a strict stance during regulatory reviews, “did not play a substantive role in the debate over Replimune’s therapy.”
While investors had already digested news of RP1’s rejection, the revelation of internal disagreement at the FDA has added a new layer of concern. The fresh insight helps explain the seemingly abrupt decision and underscores the uncertainty biopharma companies can face even late in regulatory proceedings.
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