Replimune (REPL) News & Sentiment

WOBURN, Mass., March 07, 2025 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (NASDAQ: REPL), a clinical stage biotechnology company pioneering the development of novel oncolytic immunotherapies, today announced the grant of inducement equity awards to newly hired non-executive employees.

Replimune Group's solid cash position and strategic focus on niche oncology markets position it for potential success, despite market volatility and past trial setbacks. The company's RP1 and RP2 platforms target unmet needs in melanoma and other cancers, with promising data and regulatory momentum supporting their potential. The FDA's Priority Review and Breakthrough Therapy designations for RP1 underscore its potential to reshape second-line melanoma treatment and expedite market entry.

U.S. Food and Drug Administration (FDA) recently accepted the Biologics License Application (BLA) for RP1 plus nivolumab in advanced melanoma for priority review with a PDUFA date of July 22, 2025 IGNYTE-3 confirmatory trial of RP1(vusolimogene oderparepvec) plus nivolumab in advanced melanoma is enrolling Enrolled first patients in trials evaluating RP2 for the treatment of metastatic uveal melanoma and hepatocellular carcinoma WOBURN, Mass., Feb. 12, 2025 (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 third quarter ended December 31, 2024 and provided a business update.

WOBURN, Mass., Feb. 07, 2025 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (NASDAQ: REPL), a clinical stage biotechnology company pioneering the development of novel oncolytic immunotherapies, today announced the grant of inducement equity awards to newly hired non-executive employees.

The FDA accepts and grants priority review to Replimune's BLA for RP1 in combination with Opdivo for advanced melanoma. A decision is due on July 22, 2025.

WOBURN, Mass., Dec. 23, 2024 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (Nasdaq: REPL), a clinical stage biotechnology company pioneering the development of novel oncolytic immunotherapies, today announced that members of the Replimune management team will present at the 43rd Annual J.P. Morgan Healthcare Conference on Monday, January 13, 2025 at 2:15 PM PT.

Replimune has submitted its BLA of RP1 + Opdivo for the treatment of advanced melanoma patients previously treated with an anti-PD1 containing regimen. The phase 3 confirmatory IGNYTE-3 study is underway to prove yet again that RP1 + Opdivo is able to help these patients with advanced melanoma and to keep the drug marketed. The global melanoma therapeutics market size is projected to reach $17.93 billion by 2034.

BOSTON, Nov. 25, 2024 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (Nasdaq: REPL), a clinical stage biotechnology company pioneering the development of novel oncolytic immunotherapies, today announced the pricing of its public offering of 6,923,000 shares of its common stock at a public offering price of $13.00 per share. In addition, in lieu of common stock to certain investors, Replimune today announced the pricing of its public offering of pre-funded warrants to purchase 3,846,184 shares of its common stock at a purchase price of $12.9999 per pre-funded warrant, which equals the public offering price per share of the common stock less the $0.0001 per share exercise price of each pre-funded warrant. The aggregate gross proceeds from the offering are expected to be approximately $140 million, before deducting the underwriting discounts and commissions and offering expenses payable by Replimune. All securities in the offering are being offered by Replimune. In addition, Replimune has granted the underwriter a 30-day option to purchase up to an additional 1,615,377 shares of its common stock from Replimune at the public offering price, less the underwriting discounts and commissions. The offering is expected to close on November 27, 2024, subject to the satisfaction of customary closing conditions.

WOBURN, Mass., Nov. 21, 2024 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (NASDAQ: REPL), a clinical stage biotechnology company pioneering the development of novel oncolytic immunotherapies, today announced that it has submitted a biologics license application (BLA) to the FDA for RP1 (vusolimogene oderparepvec) in combination with nivolumab for the treatment of adult patients with advanced melanoma who have previously received an anti-PD1 containing regimen. The submission was made under the Accelerated Approval pathway. The Company also announced that the FDA has granted Breakthrough Therapy designation to RP1 in combination with nivolumab in the same setting.