Replimune Group, Inc. filings document regulatory, financing, governance and operating disclosures for a Nasdaq-listed clinical-stage biotechnology company focused on oncolytic immunotherapies. Recent Form 8-K reports cover FDA communications involving the RP1 Biologics License Application, including complete response letters and related Regulation FD disclosures.
The filing record also documents quarterly financial results, corporate presentation materials for RP1 and RP2 programs, amendments to the company’s loan and security agreement, and annual meeting voting results. These disclosures describe Replimune’s development-stage operating profile, capital structure arrangements, stockholder governance matters and material events tied to its cancer immunotherapy pipeline.
Replimune Group, Inc. reported that it completed a Type A meeting with the U.S. Food and Drug Administration on September 16, 2025. The meeting focused on the company’s Biologics License Application for RP1 in combination with nivolumab to treat advanced melanoma.
The company is evaluating the FDA’s feedback from this meeting to determine its next steps for the RP1 program. A news release with additional details was issued on September 18, 2025 and is included as an exhibit to this report.
Replimune Group, Inc. reported that it completed a Type A meeting with the U.S. Food and Drug Administration on September 16, 2025. The meeting focused on the company’s Biologics License Application for RP1 in combination with nivolumab to treat advanced melanoma.
The company is evaluating the FDA’s feedback from this meeting to determine its next steps for the RP1 program. A news release with additional details was issued on September 18, 2025 and is included as an exhibit to this report.
Replimune Group, Inc. filed an 8-K reporting stockholder voting results and a regulatory update. Stockholders cast tens of millions of votes for multiple director nominees, with each nominee receiving substantially more votes "for" than "withheld," such as Michael Goller with 62,116,691 votes for and 371,431 withheld.
The filing also lists vote counts on additional matters, including one item with 70,375,492 votes for and 142,326 against, and another with 61,212,356 votes for and 1,250,054 against. Separately, the company disclosed that a Type A meeting with the U.S. Food and Drug Administration has been scheduled, as announced in a news release furnished as Exhibit 99.1.
Emily Luisa Hill, Chief Financial Officer of Replimune Group, Inc. (REPL), reported the disposition of common stock on 08/15/2025. The filing shows 9,154 shares were sold at $5.37 per share to satisfy tax withholding associated with partial vesting of restricted stock units. After the sale, the reporting person beneficially owned 134,368 shares. The Form 4 notes the sale was executed under the award agreement's irrevocable "sell to cover" provision and was not a discretionary sale by the reporting person. The form was signed by an attorney-in-fact on 08/19/2025.
On 21-Jul-2025 Replimune Group, Inc. (REPL) received a Complete Response Letter (CRL) from the U.S. FDA for its Biologics License Application seeking approval of oncolytic immunotherapy RP1 (vusolimogene oderparepvec) in combination with nivolumab for the treatment of advanced melanoma. The CRL means the agency will not approve the application in its current form and requires additional information before reconsideration. Specific deficiencies and next steps were not disclosed in the 8-K.
The company furnished, but did not “file,” a news release (Exhibit 99.1) under Item 7.01/8.01. No financial statements, earnings impact, or updated guidance were provided. The setback could delay potential commercialization and future revenue for RP1, increasing regulatory uncertainty and development costs.