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WOBURN, Mass. - Replimune Group, Inc. (NASDAQ:REPL) presented new biomarker and updated clinical data from its IGNYTE trial testing RP1 combined with nivolumab in melanoma patients who previously failed anti-PD-1 therapy, according to a company press release. The clinical-stage biotechnology company, currently valued at approximately $660 million, has seen its stock decline 12.6% over the past week, though it’s shown strong returns over the past three months according to InvestingPro data.
The late-breaking abstract presented at the Society for Immunotherapy of Cancer (SITC) Annual Meeting showed the treatment combination reversed multiple resistance mechanisms to PD-1 blockade and led to upregulation of gene signatures associated with responsiveness to PD-1 therapy.
With seven months of additional follow-up, the combination demonstrated a 33.6% objective response rate with a median duration of response of 24.8 months. The company reported consistent response duration across PD-L1-positive and negative tumors, as well as in both primary and secondary resistance settings.
Two additional poster presentations at the conference showed the treatment combination demonstrated comparable efficacy in BRAF-mutant and BRAF-wild-type advanced melanoma, with greater activity observed in BRAF-naïve patients. Another poster indicated extended RP1 treatment beyond eight doses was well tolerated and provided clinical benefit in a majority of patients.
The IGNYTE phase 2 cohort enrolled 140 patients with stage IIIB-IV cutaneous melanoma who had confirmed progression on anti-PD1-based therapy for more than eight weeks as their last prior treatment.
RP1, also known as vusolimogene oderparepvec, is based on a proprietary strain of herpes simplex virus engineered with a fusogenic protein and GM-CSF, designed to maximize tumor killing potency and activate a systemic anti-tumor immune response.
In other recent news, Replimune Group has seen a series of analyst upgrades following the FDA’s acceptance of its resubmitted Biologics License Application (BLA) for RP1 in combination with nivolumab. The FDA has set a Prescription Drug User Fee Act (PDUFA) date of April 10, 2026. H.C. Wainwright upgraded the company’s stock rating to Buy, citing increased approval chances, and set a price target of $12.00 per share. Leerink Partners also upgraded Replimune to Outperform, establishing a price target of $13.00, following the BLA acceptance. Similarly, Wedbush upgraded Replimune from Neutral to Outperform and raised its price target to $18.00, highlighting the FDA’s acceptance as a significant step forward. BMO Capital upgraded Replimune from Underperform to Market Perform, raising its price target to $11.00, based on cautious optimism surrounding FDA approval for the RP1 treatment. These developments reflect a positive shift in analyst sentiment toward Replimune’s prospects in treating advanced melanoma.
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