Replimune (REPL) Company Overview

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.

Oral presentation highlighting IGNYTE primary analysis data shows anti-tumor activity across all subgroups with injected and non-injected lesions responding with similar frequency, depth, duration, and kinetics

WOBURN, Mass., Nov. 08, 2024 (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.

Data from the IGNYTE primary analysis shows clinically meaningful activity across all subgroups, including those who had received prior anti-PD1 and anti-CTLA-4 or had primary resistance to anti-PD1

Confirmatory Phase 3 Trial to assess efficacy and safety of the investigational oncolytic immunotherapy, RP1 (vusolimogene oderparepvec) in combination with nivolumab in patients with advanced melanoma Confirmatory Phase 3 Trial to assess efficacy and safety of the investigational oncolytic immunotherapy, RP1 (vusolimogene oderparepvec) in combination with nivolumab in patients with advanced melanoma