Replimune Group

REPL

Market cap $814M

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

WOBURN, Mass., May 31, 2026 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (NASDAQ: REPL), a clinical-stage biotechnology company pioneering the development of novel oncolytic immunotherapies, today presented final first-in-human data for RP2 alone and in combination with nivolumab in patients with advanced solid tumors during an oral session at the 2026 American Society of Clinical Oncology annual meeting.

WOBURN, Mass., May 30, 2026 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (NASDAQ: REPL), a clinical-stage biotechnology company pioneering the development of novel oncolytic immunotherapies, today presented 3-year landmark overall survival data from the IGNYTE clinical trial of RP1 plus nivolumab in patients with anti-PD-1 failed melanoma during an oral session at the 2026 American Society of Clinical Oncology annual meeting.

Replimune representatives met with White House officials in early May and by the end of month, the Food and Drug Administration was planning to review the melanoma medication again.

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.

Replimune said ​on Friday ‌it it has reached ​an ​agreement with the ⁠U.S. ​Food and ​Drug Administration to resubmit the ​marketing ​application for its ‌experimental ⁠skin cancer drug after ​the ​regulator ⁠twice declined to ​approve ​the ⁠therapy.

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.

NEW YORK, May 19, 2026 (GLOBE NEWSWIRE) -- 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.