Every 8-K that Replimune Group, Inc. (REPL) has filed with the SEC in the last 24 months is listed below, newest first, and each one links through to the document itself with the summary and the scores our analysis gives it.
A 8-K covers material events a company has to report between its quarterly reports, so if you follow REPL and want that one kind of document rather than the whole filing history, this is the page to keep. The company's other filings, of every form, are on the full REPL filings page.
Replimune Group, Inc. reported fiscal first quarter 2027 results for the period ended June 30, 2026 and highlighted a transformational regulatory milestone. On August 6, 2026, the FDA granted accelerated approval for TUDRIQEV (vusolimogene oderparepvec-wtpg) in combination with nivolumab for adults with unresectable advanced cutaneous melanoma whose disease progressed on a PD‑1 antibody-based regimen. The company has started U.S. launch preparations and expects product to reach the market within 60 days.
Replimune also completed a $150 million financing to support the TUDRIQEV commercial launch and the IGNYTE‑3 confirmatory trial, and appointed Michelle DiNapoli as Chief Commercial Officer. For the quarter, total operating expenses were $68.2 million, down from $90.4 million a year earlier, leading to a net loss of $69.8 million versus $86.7 million. Cash, cash equivalents and short-term investments were $195.3 million as of June 30, 2026. The company states that existing cash, plus $141.0 million in net proceeds from an August 2026 common stock issuance, is expected to fund operations for more than twelve months, including commercialization of TUDRIQEV and general corporate purposes.
Replimune Group, Inc. describes an underwritten offering of 9,701,490 shares of common stock and pre-funded warrants to purchase 2,736,340 shares, and amends prior disclosure to correct the initial beneficial ownership limits on those warrants. The shares are priced at $12.06 each and the pre-funded warrants at $12.0599, reflecting a $0.0001 exercise price.
The pre-funded warrants are exercisable after issuance but include a 4.99% beneficial ownership cap, adjustable up to 19.99% with 61 days prior notice. Replimune estimates $140.5 million in net proceeds from the offering, conducted with Leerink Partners, J.P. Morgan Securities, and Cantor Fitzgerald under an effective Form S-3 shelf registration.
Replimune Group, Inc. entered into an underwriting agreement with Leerink Partners, J.P. Morgan and Cantor Fitzgerald for a primary underwritten offering of its equity. The company is issuing 9,701,490 shares of common stock and pre-funded warrants to purchase 2,736,340 shares of common stock.
The common shares are priced at $12.06 per share, and the pre-funded warrants at $12.0599 each, reflecting a $0.0001 per share exercise price on the warrants. Replimune expects gross proceeds of approximately $150 million and estimates net proceeds of approximately $140.5 million after underwriting discounts, commissions and expenses. The offering, made under an existing Form S-3 shelf registration statement, is expected to close on or about August 11, 2026, subject to customary conditions.
The pre-funded warrants are exercisable at any time after issuance, subject to a 9.99% beneficial ownership cap, which holders can adjust (up to 9.99%) with 61 days’ prior notice. All securities in the offering are being sold by Replimune.
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. 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. 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, 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. reported that the U.S. Food and Drug Administration issued a second Complete Response Letter for its Biologics License Application for RP1 in combination with nivolumab for treating advanced melanoma.
The company states that, without timely accelerated approval, continued development of RP1 will not be viable and it will eliminate jobs, including substantially scaling back its U.S.-based manufacturing operations. This follows data from the IGNYTE trial where patients with advanced melanoma progressing on prior anti-PD-1 therapy receiving RP1 plus nivolumab showed a 34% response rate with a median response duration of 24.8 months and a favorable safety profile.
Replimune Group, Inc. amended its Loan and Security Agreement with Hercules Capital and other lenders, extending a key revenue milestone date to September 30, 2027 and modifying several loan tranches. As part of this Third Amendment, the third loan tranche was increased to $35 million and fully funded on January 29, 2026.
The amendment adjusts future borrowing capacity and timing, including changes to the sizes and availability windows of the fourth, fifth, and sixth tranches, and sets the interest rate to the greater of 8.50% or the Prime Rate plus 1.75%. The loan amortization start date was pushed back from October 1, 2026 to October 1, 2027. The company also furnished a news release with financial results for the quarter ended December 31, 2025 as an exhibit.
Replimune Group, Inc. reported that it has released an updated corporate presentation covering recent business and strategic developments and clinical data for its RP1 and RP2 programs. The company plans to use this presentation in meetings with analysts, investors and others, including at the 44th Annual J.P. Morgan Healthcare Conference on January 14, 2026. The slide deck is furnished as Exhibit 99.1, and a replay of the J.P. Morgan presentation webcast will be available on the company’s website under “Investors and Media” for 30 days. This information is furnished under Item 7.01 and is not deemed filed or incorporated by reference into other filings unless specifically stated.
Replimune Group, Inc. furnished a current report describing that it issued a news release with its financial results for the second fiscal quarter ended September 30, 2025 and certain corporate updates. The news release is attached as Exhibit 99.1. The company clarifies that this earnings information, including Exhibit 99.1, is being furnished under the securities laws rather than filed, which limits how it is treated for certain liability and incorporation-by-reference purposes.
Replimune Group, Inc. (REPL) announced a key regulatory milestone. The FDA accepted the company’s resubmission of its Biologics License Application for RP1 in combination with nivolumab to treat patients with advanced melanoma. The FDA set a PDUFA date of April 10, 2026 based on a Class II resubmission timeline.
The acceptance confirms the application is filed for review and establishes a clear decision date. Replimune furnished a related news release as Exhibit 99.1. Outcomes will depend on the FDA’s review of the RP1 plus nivolumab data package.
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.
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.