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’s annual report centers on its oncolytic immunotherapy pipeline and a pivotal U.S. approval bid for lead candidate RP1 in advanced melanoma. RP1, used with nivolumab, showed durable responses and a median overall survival of 32.9 months in anti–PD‑1‑failed melanoma.
The RP1 Biologics License Application has twice received FDA Complete Response Letters, but a resubmission has now been accepted as a Class 1 review with an August 2, 2026 action date and an advisory committee meeting planned. The company warns that failure to gain accelerated approval could force it to halt RP1 development for melanoma and consider restructuring.
Replimune Group, Inc. reported fiscal fourth quarter and full-year 2026 results and a corporate update. For the year ended March 31, 2026, operating expenses were $319.9 million, leading to a net loss of $313.9 million, or $3.38 per share.
Cash, cash equivalents and short-term investments were $268.9 million as of March 31, 2026, and the company expects this to fund operations into the first quarter of calendar 2027. The FDA accepted the resubmitted BLA for lead candidate RP1 in advanced melanoma with a goal date of August 2, 2026 and an advisory committee meeting expected in late July.
Replimune Group, Inc. reported that the FDA has accepted for review its resubmitted Biologics License Application for RP1 (vusolimogene oderparepvec) in combination with nivolumab to treat advanced melanoma. The FDA classified the filing as a complete, class 1 response with a goal decision date of August 2, 2026 and plans an advisory committee meeting in late July.
The company is seeking accelerated approval based on data from the IGNYTE trial in patients whose disease progressed on prior anti–PD-1 therapy, a population with limited options. The release highlights the significant unmet need in advanced melanoma and Replimune’s broader oncolytic immunotherapy platform.
Replimune Group Chief Commercial Officer Christopher Sarchi sold 12,000 shares of common stock in an open-market transaction. The sale occurred on June 1, 2026 at a weighted average price of $9.24 per share, with individual trade prices ranging from $9.15 to $9.62 per share.
After this transaction, Sarchi directly holds 180,962 Replimune shares. The filing notes that the sale was executed under a pre-arranged trading plan adopted on December 15, 2025 intended to comply with Rule 10b5-1(c), indicating it was scheduled in advance rather than timed discretionarily.
Replimune Group, Inc. announced that, after collaborative discussions with the U.S. Food and Drug Administration, it plans to resubmit its Biologics License Application for RP1 (vusolimogene oderparepvec) in combination with nivolumab for advanced melanoma.
The FDA has indicated it will treat the resubmission as an urgent matter and prioritize its review, reflecting the unmet medical need for patients whose disease has progressed after prior anti‑PD‑1 therapy. The BLA is supported by data from the IGNYTE clinical trial of RP1 plus nivolumab in this difficult-to-treat population.
Replimune highlights that melanoma is the fifth most common cancer in the U.S. and the most lethal form of skin cancer, with many patients not responding to current immune checkpoint therapies, underscoring the rationale for developing RP1.
Replimune Group, Inc. Schedule 13G reports that Ridgeback entities beneficially own 6,252,651 shares of common stock, representing 7.6% of the class based on January 30, 2026 outstanding share count. The reporting group is Ridgeback Capital Investments L.P., Ridgeback Capital Investments LLC, and Ridgeback Capital Management LLC.
The filing states that the shared voting and dispositive power over these shares is 6,252,651 and that RCI and RCM may be deemed to beneficially own all shares by Rule 13d-3; each disclaims ownership except to the extent of any pecuniary interest. Signatures by counsel are dated 05/21/2026.
Replimune Group, Inc. Chief Medical Officer Konstantinos Xynos reported an open-market sale of 14,023 shares of common stock on May 18, 2026 at a weighted average price of $5.08 per share. According to the disclosure, the shares were sold solely to cover tax withholding obligations from the partial vesting of his Restricted Stock Units under an irrevocable “sell to cover” provision, meaning the transaction was not a discretionary sale. After this tax-related sale, he continues to hold 235,662 shares directly.
Replimune Group, Inc. Chief Accounting Officer Andrew Schwendenman reported an open-market sale of 7,894 shares of common stock at a weighted average price of $5.08 per share. According to the disclosure, the shares were sold solely to cover tax withholding obligations arising from a partial vesting of his Restricted Stock Units under a pre-set “sell to cover” provision, rather than a discretionary sale. Following this transaction, he directly holds 107,057 shares of Replimune common stock.
Replimune Group, Inc.’s Chief Commercial Officer Christopher Sarchi reported an open-market sale of 8,626 shares of common stock at a weighted average price of $5.08 per share. According to the disclosure, these shares were sold solely to cover tax withholding obligations tied to a partial vesting of his restricted stock units under an irrevocable “sell to cover” provision, meaning the transaction was not a discretionary sale. After this tax-related sale, Sarchi directly holds 192,962 shares of Replimune common stock.
Replimune Group, Inc. director Philip Astley-Sparke reported an open-market sale of 17,657 shares of common stock at a weighted average price of $5.08 per share. The shares were sold under an irrevocable “sell to cover” provision to satisfy tax withholding on partially vesting RSUs and are described as non-discretionary.
The filing notes the trades occurred at prices ranging from $5.02 to $5.08 per share. Following this tax-related sale, Astley-Sparke directly holds 1,412,414 shares of Replimune common stock.