Replimune Group, Inc.

Replimune Group, Inc. (REPL) filed an 8-K on September 15, 2026, disclosing both amendments to its charter or bylaws (Item 5.03) and the results of a shareholder vote (Item 5.07). The excerpt shows only the cover page. Charter amendments at a clinical-stage biotech often precede an authorized share increase or governance restructuring — materially significant given the capital-intensive nature of oncology drug development.

Replimune Group, Inc. filed an automatic shelf registration statement (S-3ASR) on August 14, 2026, registering an unspecified amount of common stock, preferred stock, debt securities, warrants, and units for future sale on a delayed or continuous basis. As an S-3ASR filer, Replimune qualifies as a well-known seasoned issuer; the registration becomes effective immediately. No specific offering amount or timing was disclosed. The shelf registration establishes future issuance flexibility but is not dilutive on its own; actual dilution depends on whether and when specific securities are offered off the shelf.

Baker Bros. Advisors LP filed an amended Schedule 13D/A on August 12, 2026 (event date August 9), disclosing sole voting and dispositive power over 11,075,336 shares of Replimune Group (REPL), representing 11.8% of outstanding shares. Baker Bros. is a prominent life sciences investment firm known for building large, active stakes in clinical-stage biotechs. An 11.8% stake signals deep conviction in Replimune's T-VEC successor pipeline for solid tumor oncolytic virotherapy. The amendment reflects a position size or intent update.

Replimune Group (REPL) filed its final 424B5 prospectus supplement for a $150 million public offering: 9,701,490 shares and 2,736,340 pre-funded warrants at $12.0600 per share (or $12.0599 per pre-funded warrant), raising gross proceeds of $149,999,956. Underwriting discounts total $9,000,014 (6%), leaving net proceeds of $140,999,942 before expenses. Delivery is expected on or about August 12, 2026. Bookrunners are Leerink Partners, J.P. Morgan, and Cantor Fitzgerald.

Replimune Group, Inc. disclosed it will present at the FDA's Cellular, Tissue, and Gene Therapies Advisory Committee (AdCom) meeting on July 30, 2026 regarding its BLA resubmission for RP1 (vusolimogene oderparepvec) in combination with Opdivo (nivolumab) for advanced melanoma. The company furnished its AdCom presentation slides as Exhibit 99.1. This is a high-stakes regulatory catalyst event — FDA advisory panel recommendation on a BLA resubmission directly influences the probability and timing of RP1's potential approval, making this filing highly material for Replimune.

Replimune Group, Inc. (Delaware; Woburn, MA), an oncolytic virus therapy biotech, filed Amendment No. 1 to its Form S-3 shelf registration (No. 333-287537) on July 24, 2026. The body excerpt contains only the cover page without the specific dollar amount or the nature of the amendment. Shelf amendments typically update financial statements, incorporate new periodic reports, or modify offering terms; specific changes are in the full filing.

Replimune Group, Inc. announced on June 26, 2026 that the FDA 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. The BLA acceptance restarts the formal FDA review clock following an earlier review cycle. This is a material regulatory milestone for Replimune's lead program — FDA acceptance of the BLA resubmission confirms it was found sufficiently complete and sets up a potential PDUFA date and commercial launch pathway.

Replimune Group, Inc. disclosed on May 29, 2026 that following collaborative discussions with the FDA, the company will resubmit its Biologics License Application (BLA) for RP1 (vusolimogene oderparepvec) in combination with nivolumab for treatment of advanced melanoma. The news release was furnished as Exhibit 99.1. This BLA resubmission is a material positive catalyst for Replimune — it reinstates the regulatory pathway toward potential approval of its lead oncology asset after the original filing's FDA review process.