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.
State Street Corporation has reported a sizeable institutional position in Replimune Group Inc. common stock on a Schedule 13G. State Street reports that it is the beneficial owner of 4,440,144 shares of Replimune common stock, representing 5.3% of the outstanding class.
All of this position is held with shared rather than sole authority: State Street reports shared power to vote or direct the vote over 4,344,038 shares and shared power to dispose or direct the disposition of 4,440,144 shares, with no sole voting or dispositive power. The stake is held through investment management subsidiaries including SSGA Funds Management, Inc., State Street Global Advisors Europe Limited, and State Street Global Advisors Trust Company.
Replimune Group, Inc. received FDA accelerated approval for TUDRIQEV (vusolimogene oderparepvec-wtpg), in combination with nivolumab, to treat adults with unresectable advanced cutaneous melanoma that has progressed on a PD-1 antibody-based regimen. Approval is based on the IGNYTE study, where 140 patients were enrolled and 91 efficacy-evaluable patients achieved a 24.2% objective response rate and a 14.1-month median duration of response. Continued approval may be contingent on verification of clinical benefit in the ongoing Phase 3 IGNYTE-3 trial.
TUDRIQEV is an intratumorally injected HSV-1 oncolytic immunotherapy that can be administered to superficial, deep, and visceral lesions, with dosing based on tumor size. Treatment was generally well tolerated; serious adverse reactions occurred in 35% of 140 patients, and 2.9% discontinued therapy, with no grade 4 or 5 common adverse events reported. Replimune estimates roughly 10,000 injectable U.S. melanoma patients progress on PD-1 therapy across lines, is preparing a 63,000 square foot U.S. manufacturing facility to support global supply, and expects TUDRIQEV to ship in approximately 60 days alongside access support via ReplimuneConnect Plus.
Replimune Group, Inc. is reported as having significant ownership by investment manager Montanova Capital, LLC and related parties. Montanova Capital and Aaron Cowen each report beneficial ownership of 6,609,000 shares of common stock, representing 7.9% of the class, with shared voting and dispositive power over those shares. Averill Master Fund, Ltd. reports beneficial ownership of 5,610,970 shares, or 6.7% of the common stock, also on a shared voting and dispositive basis. All of the shares reported are directly owned by advisory clients of Montanova Capital, with only Averill Master Fund, Ltd. identified as holding more than 5% of the class. The reporting persons state they disclaim beneficial ownership except to the extent of their pecuniary interest.
Replimune Group, Inc. reported that the U.S. Food and Drug Administration’s Cellular, Tissue, and Gene Therapies Advisory Committee reviewed the Biologics License Application resubmission for RP1 (vusolimogene oderparepvec) plus nivolumab to treat advanced melanoma in patients who have progressed on prior anti-PD-1 therapy.
The committee examined whether the single-arm IGNYTE study reliably characterizes response rate and durability in the proposed population and whether the responses indicate systemic antitumor activity attributable to RP1. It then voted 10 to 3 that the IGNYTE efficacy results are evaluable and clinically meaningful.
Replimune’s CEO described the vote as an important step for patients with advanced melanoma and emphasized the unmet need for new options. The FDA’s target action date for the Class 1 resubmission is August 2, 2026. RP1 is an HSV-1–based oncolytic immunotherapy genetically armed with a fusogenic protein and GM-CSF to enhance tumor killing and systemic immune activation.
Replimune Group, Inc. reports that on July 30, 2026 it will attend a meeting of the U.S. Food and Drug Administration’s Cellular, Tissue, and Gene Therapies Advisory Committee to discuss its Biologics License Application resubmission for RP1 (vusolimogene oderparepvec) in combination with nivolumab for the treatment of advanced melanoma.
The company has made the related presentation slides available and furnished them as Exhibit 99.1, a company presentation dated July 30, 2026, which will be presented at the advisory committee meeting. This information is furnished rather than filed and is not automatically incorporated into the company’s other reports.
Replimune Group, Inc. is holding its 2026 virtual Annual Meeting of Stockholders on September 15, 2026 at 8:30 a.m. Eastern. Holders of common stock at the close of business on July 21, 2026, when 84,026,071 shares were outstanding, may participate and vote online.
Stockholders will consider three proposals: ratifying PricewaterhouseCoopers LLP as independent auditor for the fiscal year ending March 31, 2027; a non-binding advisory vote on compensation of named executive officers for the year ended March 31, 2026; and amending the charter to increase authorized common stock from 150,000,000 to 300,000,000 shares. The board recommends voting "FOR" each proposal.
The company uses a classified board structure. Two Class II directors, Paolo Pucci and Veleka R. Peeples‑Dyer, are not standing for reelection, so two Class II vacancies will be created after the meeting and may later be filled by board appointment. Replimune is a smaller reporting company, which permits scaled SEC disclosure requirements.
Replimune Group, Inc., a clinical-stage biotechnology company developing HSV-1–based oncolytic immunotherapies (including lead candidate RP1 with nivolumab in advanced melanoma), has filed an amended shelf registration to update a resale prospectus.
The filing covers the potential resale, from time to time, of 25,103,489 shares of common stock by entities affiliated with Baker Bros. Advisors. This consists of 11,045,336 currently held shares and 14,058,153 shares issuable upon exercise of Pre-Funded Warrants. Replimune will not receive proceeds from stockholder resales, only nominal proceeds if warrants are exercised.
The prospectus details RP1’s regulatory path, including Breakthrough Therapy designation, a BLA filed under the accelerated approval pathway, two FDA Complete Response Letters and a Class 1 BLA resubmission accepted with an August 2, 2026 action date and an advisory committee meeting set for July 30, 2026. Risk factors highlight substantial doubt about the company’s ability to continue as a going concern, with cash expected to fund operations only into the first calendar quarter of 2027 and significant dependence on the RP1 BLA outcome and future financing or strategic transactions.
Replimune Group, Inc. is asking stockholders at its fully virtual 2026 annual meeting to approve three proposals, including an amendment to its charter to increase authorized common stock from 150,000,000 to 300,000,000 shares, requiring at least 75% approval of outstanding shares present and entitled to vote.
Stockholders will also vote on ratifying PricewaterhouseCoopers LLP as independent auditor for the fiscal year ending March 31, 2027 and a non-binding advisory “Say on Pay” vote on compensation for named executives for the year ended March 31, 2026.
The meeting is set for September 15, 2026 at 8:30 a.m. Eastern Time, with a record date of July 21, 2026. Two Class II directors (Paolo Pucci and Veleka R. Peeples-Dyer) are not standing for reelection, creating vacancies under the company’s classified board structure. The proxy also details board and committee composition, independence determinations, director cash and equity compensation, and governance policies including an insider trading policy, anti-hedging and pledging restrictions, and a Dodd-Frank–compliant clawback policy. Replimune reports that it qualifies as a smaller reporting company, allowing reduced disclosure obligations.