H.C. Wainwright upgrades Replimune stock rating to Buy on RP1 approval chances

Investing.com - H.C. Wainwright upgraded Replimune Group (NASDAQ:REPL) from Neutral to Buy on Monday, setting a price target of $12.00 per share. The stock, currently trading at $8.80, has shown strong momentum with a significant recovery in the past three months, despite falling 50% over the previous six months. According to InvestingPro data, analyst targets for REPL range from $2 to $18 per share.

The upgrade follows the FDA’s acceptance of Replimune’s resubmitted Biologics License Application (BLA) for RP1 in combination with Opdivo for treating adult patients with advanced melanoma who previously received an anti-PD1 containing regimen.

The FDA has established a Prescription Drug User Fee Act (PDUFA) date of April 10, 2026, for this Class II resubmission, which the agency indicated is considered a comprehensive response to the Complete Response Letter (CRL) issued in July 2025.

H.C. Wainwright has increased its probability assessment for approval of the RP1-Opdivo combination therapy from 50% to 85% based on this regulatory development.

The BLA submission is supported by results from Replimune’s IGNYTE clinical trial, which evaluated the therapy in melanoma patients who had previously failed anti-PD1 treatment.

In other recent news, Replimune Group has received significant attention following the FDA’s acceptance of its resubmitted Biologics License Application (BLA) for its RP1 treatment in combination with nivolumab for advanced melanoma patients. The FDA has set a Prescription Drug User Fee Act (PDUFA) date for April 10, 2026. This acceptance has prompted several analyst firms to adjust their ratings for Replimune. Leerink Partners upgraded the stock from Market Perform to Outperform, setting a price target of $13.00. Similarly, Wedbush upgraded Replimune from Neutral to Outperform, raising its price target to $18.00 from $4.00. Meanwhile, H.C. Wainwright maintained its Neutral rating after a Type A meeting with the FDA regarding the Complete Response Letter (CRL) previously issued for the RP1 therapy. The CRL had highlighted concerns about the IGNYTE trial’s evidence of effectiveness and patient population heterogeneity. These developments are crucial for investors monitoring Replimune’s progress in the pharmaceutical sector.

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