Replimune Group

REPL

Market cap $859M

SAN DIEGO, July 15, 2026 (GLOBE NEWSWIRE) -- Johnson Fistel, PLLP is investigating potential claims on behalf of current, long-term shareholders of Replimune Group, Inc. (NASDAQ: REPL) against certain of its officers and directors for alleged breaches of fiduciary duty.

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.

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.