Replimune Shares Plunge 64% After FDA Rejects RP1 Melanoma Therapy, Plans Layoffs
Replimune Group received a Complete Response Letter from the FDA for its RP1 melanoma therapy combined with nivolumab, halting approval based on its IGNYTE clinical program. Shares plunged 64% following the decision and the company announced plans to reduce headcount.
1. FDA Rejects RP1 Therapy
Replimune received a Complete Response Letter from the FDA blocking approval of its lead melanoma therapy RP1 in combination with nivolumab, based on data from its IGNYTE clinical program. This represents the second FDA rejection for RP1, challenging the therapy’s path to market.
2. Shares Plummet
The announcement triggered a 64% collapse in Replimune’s share price on Nasdaq, marking one of the steepest single-day declines in recent biotech sector activity. Investors reacted sharply to the setback, reflecting doubts about future revenue from RP1.
3. Planned Layoffs
In response to the FDA decision, Replimune plans to reduce headcount to align operating expenses with revised development timelines. The company aims to preserve cash and extend its financial runway, though specific layoff figures and updated burn-rate projections have yet to be disclosed.