Replimune Stock Plunges Over 20% Ahead of Key FDA Panel Meeting

Shares of Replimune (NASDAQ: REPL) fell sharply in pre-market trading, plunging 21.7% as investors aggressively reduced their exposure ahead of a pivotal U.S. regulatory review for the company's lead cancer therapy.

High-Stakes FDA Review

The sell-off comes just days before the FDA’s Cellular, Tissue, and Gene Therapies Advisory Committee (AdCom) is scheduled to convene on July 30, 2026. The panel will evaluate Replimune's Biologics License Application (BLA) for RP1 (vusolimogene oderparepvec), an investigational oncolytic immunotherapy for advanced melanoma when used in combination with nivolumab.

The Food and Drug Administration has set a Prescription Drug User Fee Act (PDUFA) goal date of August 2, 2026, for its final decision. While the advisory committee's recommendation is non-binding, it is typically a strong indicator of the agency's final ruling, making the upcoming meeting a high-stakes event for the company and its investors.

Context and Market Indicators

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Investor anxiety is amplified by Replimune's regulatory history. This marks the company's third attempt to secure approval for RP1 after receiving two prior complete response letters from the FDA, signaling previous deficiencies in its applications.

Recent market activity has signaled growing caution among traders. Today's pre-market decline follows a 12.4% drop in Replimune's stock on July 27. Other indicators of bearish sentiment, according to the source, include:

• Options Market: Put volume in early July was reportedly running at approximately three times the expected level.
• Insider Activity: Company insiders sold roughly $0.6 million worth of shares over the past three months, with no corresponding insider buying reported.

The selling pressure on Replimune was exacerbated by broader market weakness, particularly in the technology sector, with the Nasdaq Composite trading down 1.2% in the session.