Replimune’s stock collapsed ~75%—from around $12 to under $3—after the FDA issued a Complete Response Letter (CRL) for its RP1 melanoma therapy. The rejection stemmed from trial design flaws in the Phase III IGNYTE study, especially its heterogenous patient population and lack of adequate control, which undermined evidence of effectiveness
Analysts linked the surprise decision to the FDA’s tougher stance under new leadership
the FDA’s shift under Prasad
Under Vinay Prasad, the FDA sharply increased scrutiny over accelerated approvals and uncontrolled data. Known for demanding randomized, well‑controlled trials and expressing skepticism toward surrogate endpoints, Prasad’s tenure signaled a “no shortcuts” era—becoming the central catalyst for the RP1 rejection
Prasad’s exit and possible reopening of avenues
Now, with Prasad’s departure announced on July 30, 2025, the regulatory tone may soften. His exit relieves the leadership pressure that contributed to the strict enforcement on programmes like RP1. The removal of that obstacle could pave the way for Replimune to re-engage with the FDA under a more flexible, possibly constructive clinical dialogue
Three steps to potential recovery:
Request a Type A meeting: Replimune has already said it will formally seek one within 30 days. With Prasad gone, this discussion may focus on recalibrating trial design rather than reinforcing rejection
Redesign the IGNYTE follow‑up: Reworking heterogeneity and control issues—perhaps via a randomized confirmatory study—may satisfy FDA standards more aligned with prior norms.
Rebuild investor confidence: Emphasizing regulatory change, a clear revised pathway, and RP1’s clinical promise can help stabilize stock sentiment.
Prasad’s exit may be the turning point that shifts market sentiment and reopens the door for RP1. It is the time for Replimune to pivot—and for investors to watch whether a new FDA leadership landscape might bring renewed opportunity.
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