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Investing.com - Cantor Fitzgerald has reiterated its Overweight rating on Replimune Group (NASDAQ:REPL) following the announcement of a new PDUFA date for the company’s RP1 therapy. The clinical-stage biotechnology company, currently valued at approximately $716 million, has seen its stock price demonstrate strong momentum with a 16% return over the past six months despite high price volatility.
The U.S. Food and Drug Administration has set April 10, 2026, as the PDUFA date for RP1 in combination with nivolumab for the treatment of anti-PD-1 refractory advanced melanoma.
Cantor Fitzgerald has updated its financial model for Replimune Group to reflect this regulatory timeline, while maintaining its positive outlook on the stock.
The research firm views the FDA’s acceptance of Replimune’s resubmission as a positive development toward potential accelerated approval for the RP1 therapy.
RP1 is Replimune’s lead product candidate, being developed as a potential treatment option for patients with advanced melanoma who have not responded to existing anti-PD-1 therapies.
In other recent news, Replimune Group has reported promising data from its IGNYTE trial for melanoma treatment, showcasing the effectiveness of RP1 combined with nivolumab in patients who previously failed anti-PD-1 therapy. This development was presented at the Society for Immunotherapy of Cancer Annual Meeting, highlighting the treatment’s ability to reverse resistance mechanisms to PD-1 blockade. Following these advancements, Replimune’s stock has seen a series of upgrades from several analyst firms. BMO Capital upgraded its rating from Underperform to Market Perform, citing "cautious optimism" about potential FDA approval and raised the price target to $11.00. H.C. Wainwright also upgraded Replimune to a Buy, setting a price target of $12.00, after the FDA accepted the company’s resubmitted Biologics License Application for RP1 in combination with Opdivo. Additionally, Leerink Partners and Wedbush both upgraded Replimune to Outperform, with price targets of $13.00 and $18.00, respectively, following the FDA’s acceptance of the BLA resubmission. The FDA has set a Prescription Drug User Fee Act date of April 10, 2026, marking a significant milestone for the company.
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