Replimune Shares Soar 13% on 19% RP2 Response and FDA Priority Review
REPL•Replimune saw its shares rise 13% in pre-market trading after RP2 trials showed a 19% objective response rate with tumor shrinkage in both injected and non-injected lesions. The FDA agreed to prioritize review of a resubmitted RP1 application following two prior rejections.
1. Premarket Surge on RP2 Data
Replimune’s shares jumped 13% in pre-market trading to their highest level this year as investors reacted to promising early RP2 data and regulatory progress. This surge marked the stock’s largest one-day gain in over seven months.
2. RP2 Trial Efficacy Results
In an 85-patient Phase 1 trial for advanced solid tumors, RP2 achieved a 19% objective response rate both as monotherapy and in combination with nivolumab, with tumor shrinkage observed in injected and non-injected lesions and nearly 49% disease control. The therapy also converted immunologically cold tumors into immune-active ones, boosting key anti-cancer responses.
3. FDA Priority Review and Leadership Change
The FDA has agreed to prioritize review of Replimune’s resubmitted RP1 application after two prior rejections, citing the urgent need for novel melanoma treatments. This decision followed recent leadership changes at the agency, igniting hope for a faster approval process.
4. Q4 Loss Forecast
Analysts forecast a fourth-quarter loss of $0.72 per share, narrower than the $0.82 loss in the same period last year, reflecting cost efficiencies and the potential for upcoming revenue from RP1 if approved.
