April 10, 2026 Target Action Date for RP1 in Advanced MelanomaWOBURN, Mass., Feb. 03, 2026 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (Nasdaq: REPL), a clinical stage biotechnology company pioneering the development of novel oncolytic immunotherapies, today announced financial results for the fiscal third quarter ended December 31, 2025 and provided a business update. The Company's Biologics License Application (BLA) resubmission for RP1 (vusolimogene oderparepvec) in anti-PD-1 failed melanoma was accepted b ...

Replimune Group FY Conference Summary Company Overview - **Company**: Replimune Group (NasdaqGS:REPL) - **Event**: 44th Annual J.P. Morgan Healthcare Conference - **Date**: January 14, 2026 Key Industry Insights - **Oncolytic Immunotherapy**: Replimune is focused on delivering oncolytic immunotherapy, particularly through its assets RP1 and RP2, which are designed to enhance systemic immune activation against various cancers [11][13][41]. Core Points and Arguments 1. **Commercial Launch Plans**: Replimune is prepared for a commercial launch, with plans to work closely with oncology and interventional radiology stakeholders. The logistics have been simplified for next-day delivery and room temperature stability of their product [11][22]. 2. **Expanded Treatment Scope**: The company has successfully conducted over 1,000 deep injections, expanding the treatment potential beyond superficial lesions to include deeper tumors in organs like the lung and liver [12][35]. 3. **Clinical Trial Data**: The IGNITE trial demonstrated a 34% response rate in primary resistant melanoma patients, indicating the efficacy of RP1 in difficult-to-treat populations [17][18]. The trial's design ensures that patients have definitively failed prior PD-1 treatments, providing a robust assessment of RP1's contribution [15][19]. 4. **Durability of Responses**: Analysis shows that responses to RP1 are durable, with significant improvements in time to progression compared to prior treatments [20][21]. 5. **Patient Population**: Approximately 10,000 melanoma patients are addressable, with 80% eligible for RP1 treatment. The regimen is designed to be practical and broadly applicable across various patient subtypes [22][23]. 6. **Safety Profile**: The safety profile of RP1 is reported to be tolerable, making it a viable option for a wide range of patients [23][41]. Additional Important Insights - **Regulatory Engagement**: The FDA has been responsive, and the company is optimistic about the upcoming PDUFA date on April 10, 2026, for their class two resubmission [42][43]. - **Enrollment in Trials**: Enrollment in the IGNITE-3 trial is progressing well, with over 60 patients already enrolled, and expansion into Europe is planned [49][51]. - **Compassionate Use Requests**: There has been a notable increase in compassionate use requests, indicating a strong demand for RP1 among physicians and patients [50][53]. - **Future Directions**: Replimune is exploring the use of RP1 in other cancer types beyond melanoma, including liver and biliary tract cancers, and is preparing for additional trials [40][41]. Conclusion Replimune Group is positioned to make significant advancements in the field of oncolytic immunotherapy, with a strong focus on expanding treatment options for patients with difficult-to-treat cancers. The company is ready for commercial launch and is actively engaging with regulatory bodies to ensure timely approval and access to their therapies.

Click to edit Master title style January 14, 2026 JPM Healthcare Conference Igniting a systemic immune response to cancer with oncolytic immunotherapy © 2026 Replimune Group Inc. JPM 2026 Presentation 1 Click to edit Master text styles Safe harbor © 20256 Replimune Group Inc. Replimune Group Inc. 3 Click to edit Master title style RPx Oncolytic Immunotherapy Overcoming Historical Hurdles ~150 Accounts Ready on Day 1 Go-to market model optimized to enable oncologist/interventional radiologist (IR) coordinati ...

Core Insights - Replimune Group's shares have increased by 131.1% over the last three months due to positive regulatory developments [1] - The FDA has accepted the resubmission of the biologics license application (BLA) for Replimune's lead candidate RP1 in combination with Bristol Myers' Opdivo for advanced melanoma, with a target action date set for April 10, 2026 [1][5] Regulatory Developments - The BLA resubmission follows a complete response letter (CRL) issued in July 2025, which raised concerns about data heterogeneity in the IGNYTE study population [2] - The FDA indicated that the IGNYTE study was not considered adequate for providing substantial evidence of effectiveness [2] - Replimune has engaged with the FDA to address the feedback from the CRL, and the FDA confirmed that the resubmission adequately addresses the previous concerns [3] Clinical Data - The RP1/Opdivo combination achieved a 44% response rate and an 11.9-month median response duration in patients with acral melanoma from the IGNYTE study [5][9] - Replimune is continuing a larger phase III study evaluating the RP1/Opdivo combination against the physician's choice of treatment for melanoma patients who have progressed on anti-PD1 and anti-CTLA-4 therapies [9] Market Performance - Replimune's shares have declined by 19.6% over the past year, contrasting with the industry's growth of 20.2% [4] - The acceptance of the resubmitted BLA has alleviated investor concerns regarding the RP1/Opdivo combination, leading to increased visibility and confidence in the candidate's approval path [6] Additional Pipeline Information - RP1 is also being evaluated as a monotherapy for solid organ transplant recipients with skin cancers [12] - Replimune has a second oncolytic immunotherapy candidate, RP2, currently in mid-stage to large-stage studies for metastatic uveal melanoma and hepatocellular carcinoma [12]

Core Insights - Replimune Group, Inc. reported financial results for the fiscal second quarter ended September 30, 2025, and provided a business update, highlighting progress in clinical trials and financial status [1][2]. Business Updates - The FDA accepted the Biologics License Application (BLA) resubmission for RP1, targeting advanced melanoma, with a PDUFA action date set for April 10, 2026 [2]. - The ongoing global Phase 3 trial, IGNYTE-3, is evaluating RP1 in combination with nivolumab, with an expected enrollment of approximately 400 patients [5]. - Recent data presented at the ESMO Congress 2025 showed an objective response rate (ORR) of 44% for RP1 plus nivolumab in acral melanoma, with a median duration of response of 11.9 months [5]. - RP1 plus nivolumab demonstrated a 100% ORR in anti–PD-1 naïve Merkel cell carcinoma (MCC) patients, with varying ORRs in other non-melanoma skin cancers [5]. Financial Highlights - As of September 30, 2025, the company had cash, cash equivalents, and short-term investments of $323.6 million, down from $483.8 million as of March 31, 2025, due to cash burn from clinical development activities [8]. - Research and development expenses for the fiscal second quarter were $57.9 million, an increase from $43.4 million in the same quarter of the previous year, primarily due to costs associated with the IGNYTE-3 study [12]. - Selling, general and administrative expenses rose to $26.4 million from $15.5 million year-over-year [12]. - The net loss for the fiscal second quarter was $83.1 million, compared to $53.1 million in the same quarter of the previous year [12]. Upcoming Events - Replimune will present late-breaking oral presentations and posters at the Society for Immunotherapy of Cancer (SITC) 2025 Annual Meeting, showcasing updated clinical data for RP1 plus nivolumab [11].

Core Insights - Replimune Group, Inc. presented data on RP1 plus nivolumab at the 2025 ASCO Annual Meeting, highlighting robust responses in both injected and non-injected lesions, with deep injections showing higher response rates compared to superficial injections [1][2][4] Group 1: Clinical Trial Findings - The IGNYTE clinical trial involved 140 anti-PD-1 failed melanoma patients, showing an objective response rate (ORR) of 32.9% and a complete response rate of 15.0% [4] - Landmark overall survival (OS) rates at 1, 2, and 3 years were reported as 75.3%, 63.3%, and 54.8% respectively, with median OS not yet reached [4] - Deep injections resulted in higher ORR: 29.8% for superficial injections, 42.9% for deep/visceral plus superficial injections, and 40.9% for deep/visceral injections only [4] Group 2: Safety and Tolerability - RP1 injections into the liver and lung were generally well tolerated, with few organ-specific adverse events [4] - No bleeding events were reported after liver injections, and lung injections had low rates of pneumothorax, typically of low grade and manageable [4] - Standard disinfection procedures were confirmed sufficient for RP1 clean-up, with no transmission of RP1 reported to date [10] Group 3: Product Information - RP1 is Replimune's lead product candidate, engineered from a proprietary strain of herpes simplex virus, designed to maximize tumor killing potency and activate a systemic anti-tumor immune response [6][8] - The RPx platform aims to induce a strong and durable systemic response while being synergistic with various cancer treatment modalities [8]