Wedbush upgrades Replimune Group stock rating on FDA acceptance of BLA

Investing.com - Wedbush upgraded Replimune Group (NASDAQ:REPL), currently trading at $9.05 with a market capitalization of $707 million, from Neutral to Outperform and raised its price target to $18.00 from $4.00 following FDA acceptance of the company’s Biologics License Application (BLA) for its RP1 (Tudriqev) therapy. InvestingPro data shows the stock has demonstrated strong returns over the past month despite significant volatility.

The FDA has set a PDUFA date of April 10, 2026, for the BLA submission, which is considered a complete response to the Complete Response Letter (CRL) Replimune received in July. The original CRL indicated the FDA did not consider the IGNYTE trial to provide substantial evidence of effectiveness due to patient population heterogeneity. According to InvestingPro, the company maintains a strong liquidity position with a current ratio of 6.94, suggesting ample resources to support its regulatory journey.

The BLA seeks approval for RP1 in combination with nivolumab for treating advanced melanoma. This combination previously demonstrated a 33% objective response rate and a median duration of response of 33.7 months across difficult-to-treat patient subgroups.

Wedbush views the FDA’s acceptance of the resubmission as "highly promising" following Replimune’s Type A meeting with the agency. The firm assumes the FDA has given "somewhat of a green light" for the resubmission, which includes additional information addressing previous concerns.

The analyst noted that RP1 combined with nivolumab shows a "highly manageable toxicity profile" that appears differentiated in the post-immune checkpoint inhibitor setting, though Wedbush maintains a "marginally higher discount rate" due to what it describes as "cautious optimism" toward approval.

In other recent news, Replimune Group Inc . experienced significant developments regarding its melanoma treatment. The U.S. Food and Drug Administration accepted Replimune’s resubmission of its Biologics License Application for RP1 in combination with nivolumab, aimed at treating advanced melanoma patients. The FDA has set a Prescription Drug User Fee Act date of April 10, 2026, for this application. Despite this progress, Replimune faced challenges, as a Type A meeting with the FDA did not establish a clear regulatory path forward for the treatment, following concerns highlighted in a Complete Response Letter. These concerns included issues with the trial’s evidence of effectiveness and patient population heterogeneity. H.C. Wainwright maintained a Neutral rating on Replimune, reflecting ongoing regulatory uncertainties. Conversely, JPMorgan downgraded Replimune’s stock from Neutral to Underweight, citing regulatory concerns despite acknowledging the treatment’s compelling data. These developments highlight the complex regulatory landscape Replimune navigates as it seeks approval for its melanoma treatment.

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