REPL Stock Soars: Is Replimune the Biotech Breakout Investors Have Been Waiting For?

Shares of Replimune Group Inc. (NASDAQ: REPL) surged in pre-market trading on Monday after the U.S. Food & Drug Administration accepted the company’s resubmitted Biologics License Application (BLA) for RP1, an oncolytic immunotherapy being paired with Bristol Myers Squibb’s nivolumab for advanced melanoma. The agency set a Prescription Drug User Fee Act (PDUFA) target date of April 10, 2026, giving investors a clear regulatory timeline and sparking a rush of volume that lifted REPL as much as 38 % to an intraday high of $6.27—its strongest level since mid-August. By 10 a.m. ET, more than six times the stock’s 30-day average volume had already changed hands. Why the acceptance matters • Regulatory reset: FDA acceptance means the agency found the company’s quality, manufacturing and clinical data ready for formal review, reversing the complete response letter issued in June that focused on CMC issues. • First-in-class potential: RP1 is designed to directly lyse tumor cells while simultaneously priming systemic anti-tumor immunity. If approved, it would become the first oncolytic virus therapy in melanoma since T-Vec in 2015, giving Replimune a potential foothold in a market estimated at $5 billion annually. • Strategic partnership: The combination with nivolumab (Opdivo) could unlock additional upside via co-commercialization discussions with Bristol Myers Squibb should the regimen reach market. Market reaction and technical setup The FDA update propelled REPL through key resistance at its 50-day moving average near $4.90, turning that level into potential short-term support. Next upside target sits at $7.40, the stock’s May swing high. Options volume also spiked, with call contracts outnumbering puts 5-to-1 as traders positioned for continued momentum. Financial snapshot Replimune ended its June quarter with $519 million in cash, enough runway to operate into 2H 2027 even if RP1 launches slowly, according to management’s last guidance. Analysts remain divided: two firms rate the name “buy,” five “hold” and two “sell,” with an average price target of $4.67—well below today’s highs, suggesting many on the Street will need to revisit their models if the regulatory path stays on track. What comes next Investors should watch for an FDA mid-cycle review update in February that could hint at review progress or signal the need for an advisory committee meeting. Replimune also plans to present updated overall-survival data from its Phase 2 CERPASS study at an oncology conference later this quarter, providing another catalyst to sustain interest. Bottom line With its BLA officially accepted and a PDUFA date set, Replimune has reclaimed credibility just months after a regulatory setback. The road to commercialization is far from guaranteed, but today’s decision sharply alters the risk-reward profile for REPL stock and puts the biotech back on radar screens of growth-oriented and event-driven investors alike.