FDA Advisory Panel to Review Replimune's RP1 After Two Prior Rejections

Key Facts

In a move signaling a shift in regulatory momentum, Replimune is preparing for an FDA Advisory Committee (AdCom) meeting for its experimental therapy RP1, following two prior rejections. The resubmission is supported by clinical data showing a 34% objective response rate and a median overall survival of 32.9 months in advanced melanoma patients who failed anti-PD-1 therapy. The committee's decision, expected ahead of the August 2 PDUFA date, could determine the therapy's path to market.

The resubmission was enabled by leadership changes at the FDA that reopened a regulatory dialogue, according to industry reports. REPL stock surged 135% on the resubmission optimism, reflecting investor hope for approval. Peer biotech AdCom outcomes historically drive sharp volatility, making the upcoming meeting a high-stakes catalyst for the stock.

REPL closed at $11.20 on June 29, 2026, with an intraday high of $11.74. Investors now eye the August 2 decision date; a positive AdCom recommendation could fuel further gains, while an unfavorable outcome risks a sharp pullback. Any interim regulatory updates in the coming weeks will serve as additional near-term catalysts for the stock.