REPL

Replimune Group, Inc. faces a pivotal FDA AdCom for RP1 after two prior rejections, with a final FDA approval decision expected August 2, 2026. RP1 demonstrated a 34% ORR and median overall survival of 32.9 months in anti-PD-1-failed melanoma, but trial design concerns persist. REPL stock has surged over 135% since April as FDA leadership changes and collaborative dialogue opened a path for BLA resubmission.

WOBURN, Mass., June 29, 2026 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (Nasdaq: REPL), a clinical stage biotechnology company pioneering the development of novel oncolytic immunotherapies, today announced financial results for the fiscal fourth quarter and year ended March 31, 2026 and provided a business update.

WOBURN, Mass., June 26, 2026 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (NASDAQ: REPL), a clinical-stage biotechnology company pioneering the development of novel oncolytic immunotherapies, announced today that the U.S. Food and Drug Administration (FDA) has accepted for review the resubmission of the Biologics License Application (BLA) for RP1 (vusolimogene oderparepvec) in combination with nivolumab for the treatment of advanced melanoma.

Replimune stock surges after the company aligned with the FDA on plans to resubmit its BLA for RP1 plus Opdivo in advanced melanoma.

Replimune said it plans to resubmit its melanoma drug for approval following two earlier rejections. The move follows the departure of Food and Drug Administration Commissioner Marty Makary.

WOBURN, Mass., May 29, 2026 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (NASDAQ: REPL), a clinical-stage biotechnology company pioneering the development of novel oncolytic immunotherapies, today announced that following collaborative communications with the U.S. Food and Drug Administration (FDA), the Company and the FDA have aligned on a path forward for resubmission and reconsideration of the Biologics License Application (BLA) for RP1 (vusolimogene oderparepvec) in combination with nivolumab for the treatment of advanced melanoma.

Experimental melanoma drug was rejected twice because the Food and Drug Administration questioned its study design.

NEW YORK, May 21, 2026 /PRNewswire/ -- Pomerantz LLP is investigating claims on behalf of investors of Replimune Group, Inc. ("Replimune" or the "Company") (NASDAQ: REPL).  Such investors are advised to contact Danielle Peyton at newaction@pomlaw.com or 646-581-9980, ext.

LOS ANGELES, May 17, 2026 (GLOBE NEWSWIRE) -- The Schall Law Firm, a national shareholder rights litigation firm, announces that it is investigating claims on behalf of investors of Replimune Group, Inc. (“Replimune” or “the Company”) (NASDAQ: REPL) for violations of the securities laws. The investigation focuses on whether the Company issued false and/or misleading statements and/or failed to disclose information pertinent to investors.

Replimune Group, Inc.'s RP1 has failed at the FDA twice, but Makary's resignation keeps a resubmission possible. REPL's cash runway stands at under a year; workforce cuts and RP1 discontinuation are being considered. I maintain a cautious Buy on the ability for REPL to court surprising, bold turnarounds. I don't think this story is over.