Replimune stock upgraded to Outperform by Leerink on FDA acceptance of BLA

Investing.com - Leerink Partners has upgraded Replimune Group (NASDAQ:REPL) from Market Perform to Outperform and set a price target of $13.00 following the FDA’s acceptance of the company’s Biologics License Application (BLA) resubmission. According to InvestingPro data, the stock has shown strong momentum recently despite falling over 60% year-to-date, highlighting its characteristic high volatility.

Replimune announced Monday that the FDA accepted its BLA resubmission for RP1 (vusolimogene oderparepvec) in combination with nivolumab for anti-PD-1 failed melanoma. The agency has set a Prescription Drug User Fee Act (PDUFA) date of April 10, 2026, based on a Class II resubmission timeline. The company maintains a strong financial position with more cash than debt and a healthy current ratio of 6.94x, providing runway for development activities.

The FDA considered this resubmission a complete response to the Complete Response Letter (CRL) Replimune received in July. The original CRL cited concerns about patient population heterogeneity in the single-arm Phase II IGNYTE study and inadequate evidence for component contributions in both Phase II data and the ongoing Phase III IGNYTE-3 study design.

Leerink’s upgrade reflects "renewed confidence" in the RP1 program following the FDA acceptance and conversations with Replimune management, who expressed confidence in the path forward for the treatment in this indication. InvestingPro reveals that two analysts have recently revised their earnings expectations upward, though the company is not expected to be profitable this year. Get deeper insights into REPL’s financial health and 10+ additional ProTips with an InvestingPro subscription.

The research firm now models a 60% probability of success for RP1 in anti-PD-1 failed melanoma, with the new price target primarily reflecting this increased probability of success while acknowledging "some remaining uncertainties with the review process." With analyst targets ranging from $2 to $8, investors can access comprehensive valuation analysis and detailed financial metrics through InvestingPro’s Research Reports, available for over 1,400 US stocks.

In other recent news, Replimune Group has seen several significant developments regarding its RP1 therapy. The U.S. Food and Drug Administration (FDA) has accepted Replimune’s resubmitted Biologics License Application (BLA) for RP1 in combination with nivolumab, aimed at treating advanced melanoma patients who have progressed on anti-PD-1 regimens. The FDA has set a Prescription Drug User Fee Act (PDUFA) date of April 10, 2026, for this application. Following this acceptance, Wedbush upgraded Replimune’s stock rating from Neutral to Outperform, raising its price target to $18.00, citing the FDA’s acceptance as a positive development.

However, contrasting analyst opinions have emerged, as JPMorgan downgraded Replimune’s stock rating from Neutral to Underweight, removing its previous price target due to regulatory concerns, despite acknowledging the treatment’s compelling data. Meanwhile, H.C. Wainwright maintained a Neutral rating on Replimune following a Type A meeting with the FDA, which addressed the Complete Response Letter (CRL) concerns related to the RP1 therapy. The CRL had highlighted issues with the IGNYTE trial, particularly regarding patient population heterogeneity and evidence of effectiveness. These recent developments underscore the mixed sentiment among analysts about Replimune’s prospects.

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