Replimune Group Inc.(REPL) on Monday announced that it has cleared a major regulatory hurdle after the U.S. Food and Drug Administration (FDA) accepted its resubmitted Biologics License Application (BLA) for RP1, a treatment for advanced melanoma.
The FDA has set April 10, 2026, as the Prescription Drug User Fee Act (PDUFA) target action date for this Class II resubmission.
Following the update, Replimune stock traded over 98% higher on Monday morning and was the third most trending equity ticker on Stocktwits. Retail sentiment around the stock jumped to ‘extremely bullish’ from ‘bearish’ territory the previous day while message volume improved to ‘extremely high’ from ‘low’ levels in 24 hours.
RP1 is Replimune’s lead therapy candidate. It is derived from a modified herpes simplex virus, engineered to enhance tumor cell destruction and stimulate the body’s immune system against cancer. The therapy is designed with a fusogenic protein (GALV-GP R-) and GM-CSF to amplify both tumor-killing activity and the immune response.
“RP1 plus nivolumab offers a strong risk benefit profile where there are few options for patients with advanced melanoma, who have progressed on PD-1 based therapy."
- Sushil Patel, CEO, Replimune.
The BLA resubmission follows several months of engagement between the company and the agency. Replimune worked to incorporate additional clinical data, detailed analyses and supporting documentation to address regulatory concerns.
Wedbush raised its rating on Replimune to ‘Outperform’ from ‘Neutral’ and increased its price target to $18 from $4, according to TheFly. The firm sees the FDA’s quick response after a Type A meeting as an encouraging sign, suggesting the agency is open to the updated application with the new data included.
Leerink analyst Jonathan Chang raised the firm’s rating to ‘Outperform’ from ‘Market Perform’ and lifted the price target to $13 from $3, expressing renewed confidence in RP1.
Replimune stock has lost over 14% in the last 12 months.
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