Replimune Group, Inc. (REPL)
Replimune Group, Inc. is a biotechnology company focused on developing proprietary immunotherapies for cancer treatment. Its cathepsin-based oncolytic immunotherapies aim to activate the immune system to recognize and destroy tumors, with a focus on combining these therapies with other cancer treatments to enhance efficacy.
Company News
Replimune Group's stock surged after the FDA accepted its resubmitted Biologics License Application for RP1, an investigational drug targeting advanced melanoma when combined with Bristol Myers Squibb's Opdivo.
Replimune Group resubmitted a Biologics License Application to the FDA for RP1, an oncolytic immunotherapy for advanced melanoma patients who progressed on anti-PD-1 therapy. The PDUFA date is set for April 10, 2026.
The Schall Law Firm is pursuing a class action lawsuit against Replimune Group for allegedly making false and misleading statements about its IGNYTE trial for RP1, potentially misleading investors between November 2024 and July 2025.
Replimune's (REPL) lead pipeline candidate RP1, in combination with Opdivo, leads to an overall response rate of 33.6% in patients with anti-PD1 failed melanoma. Shares gain.