Core Viewpoint - Rosen Law Firm is investigating potential securities claims on behalf of shareholders of Replimune Group, Inc. due to allegations of materially misleading business information issued by the company [1]. Group 1: Company Information - Replimune Group, Inc. received a Complete Response Letter (CRL) from the FDA regarding its Biologics License Application (BLA) for RP1, indicating that the application cannot be approved in its current form [3]. - The FDA stated that the IGNYTE trial does not provide substantial evidence of effectiveness, which contributed to a significant drop in Replimune's stock price [3]. - Following the announcement of the CRL, Replimune's common stock fell by $9.52 per share, representing a decline of over 77%, closing at $2.80 on July 22, 2025 [3]. Group 2: Legal Action and Investor Rights - Investors who purchased Replimune securities may be entitled to compensation through a class action lawsuit, with no out-of-pocket fees due to a contingency fee arrangement [2]. - The Rosen Law Firm is preparing a class action to seek recovery of investor losses related to the misleading information [2]. - The firm emphasizes the importance of selecting qualified legal counsel with a successful track record in securities class actions [4].

Core Viewpoint - Bragar Eagel & Squire, P.C. is investigating potential claims against Replimune Group, Inc. following a significant stock price drop after the FDA issued a Complete Response Letter regarding its Biologics License Application for RP1 [1][3]. Company Summary - Replimune Group, Inc. (NASDAQ: REPL) faced a major setback when the FDA issued a Complete Response Letter on July 22, 2025, indicating that the application for RP1 in combination with nivolumab for advanced melanoma could not be approved in its current form [3]. - The FDA's letter highlighted that the IGNYTE trial was not considered adequate and well-controlled, lacking substantial evidence of effectiveness due to the heterogeneity of the patient population [3]. - Following the announcement, Replimune's stock price plummeted by $9.52, or 77.24%, closing at $2.81 per share [3]. Legal Investigation - Bragar Eagel & Squire, P.C. is encouraging investors who suffered losses from Replimune's stock decline to contact them to discuss potential legal rights and claims [1][4]. - The law firm is specifically looking into whether Replimune violated federal securities laws or engaged in unlawful business practices [1].

Core Viewpoint - Replimune Group, Inc. is under investigation for potential violations of federal securities laws following a significant decline in its stock price after receiving a Complete Response Letter from the FDA regarding its lead product RP1 [1][3]. Company Summary - Replimune received a Complete Response Letter from the FDA on July 22, 2025, indicating that its IGNYTE trial was not considered adequate for demonstrating the effectiveness of RP1 in combination with nivolumab for advanced melanoma [3]. - Following the FDA's announcement, Replimune's stock price fell by $9.52, or approximately 77.24%, closing at $2.81 per share [3]. Legal Investigation Summary - Kirby McInerney LLP is investigating potential claims against Replimune and its officers for possible violations of federal securities laws and other unlawful business practices [1][4].

Core Points - Holzer & Holzer, LLC is investigating Replimune Group, Inc. for potential compliance issues with federal securities laws following the receipt of a Complete Response Letter from the FDA regarding its Biologics License Application for RP1 [1] - The FDA's Complete Response Letter indicated that the IGNYTE trial was not considered adequate to provide substantial evidence of effectiveness for the treatment of advanced melanoma [1] - Following the announcement of the CRL, Replimune's stock price experienced a decline [1] Company Information - Replimune Group, Inc. is focused on developing treatments for advanced melanoma, specifically through the use of RP1 in combination with nivolumab [1] - The company is publicly traded on NASDAQ under the ticker REPL [1] Legal Context - Holzer & Holzer, LLC is a law firm specializing in securities litigation, representing shareholders and investors in class action and derivative litigation [3] - The firm has a history of recovering significant amounts for shareholders affected by corporate misconduct [3]

Core Viewpoint - Replimune Group, Inc. announced that the FDA issued a Complete Response Letter (CRL) for the Biologics License Application (BLA) of RP1 in combination with nivolumab for advanced melanoma treatment, indicating that the application cannot be approved in its current form [1][2] Group 1: FDA Response - The CRL states that the IGNYTE trial is not considered an adequate and well-controlled clinical investigation providing substantial evidence of effectiveness [2] - The FDA highlighted issues related to the heterogeneity of the patient population and the confirmatory trial study design that need to be addressed [2] - Importantly, the CRL did not raise any safety issues regarding the application [2] Group 2: Company Response - The company plans to request a Type A meeting with the FDA, expecting it to be granted within 30 days, to discuss a path forward for accelerated approval of RP1 [3] - The CEO expressed surprise and disappointment regarding the FDA's decision, noting that the issues raised in the CRL were not previously mentioned during mid- and late-cycle reviews [4] - The company remains confident that RP1 in combination with nivolumab can provide substantial benefits to advanced melanoma patients [4] Group 3: Product Information - RP1 (vusolimogene oderparepvec) 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 [5] - The RPx platform aims to induce immunogenic cell death and alter the tumor microenvironment to promote a strong systemic immune response [6]

RP1: IGNITING A SYSTEMIC IMMUNE RESPONSE TO CANCER - IGNYTE trial showed an objective response rate (ORR) of 32.1% by investigator assessment and 33.6% by independent central review in anti-PD1 failed melanoma patients [24, 37] - In the IGNYTE trial, 14.7% of patients achieved a complete response (CR) [24] - In the IGNYTE trial, 17.9% of patients achieved a partial response (PR) [24] - In the IGNYTE trial, 70.4% of responding patients experienced responses in non-injected lesions, demonstrating systemic benefit [28] - Responses in the IGNYTE trial are durable, with 84.2% lasting >6 months, 74.9% lasting >12 months, and 65.2% lasting >18 months [31] - The median duration of response (DOR) in the IGNYTE trial is 36.6 months [31] - In the ARTACUS clinical trial, RP1 monotherapy showed an ORR of 34.8% and a CRR of 21.7% in solid organ transplant (SOT) patients with non-melanoma skin cancers (NMSC) [51] - In locally advanced CSCC, the complete response rate more than doubled for RP1+cemiplimab vs cemiplimab alone (48.1% vs 22.6%) [71] RP2: FOCUSED ON RARE CANCERS - In uveal melanoma, RP2 monotherapy and in combination with nivolumab showed an ORR of 29.4% [90] Financial Status - The company has a strong financial position with cash of $420.7 million as of March 31, 2024, providing a cash runway into the second half of 2026 [114]

Replimune Group (REPL) 2025 Investor Day June 24, 2025 10:00 AM ET ...

RP1 Clinical Trial Results & Opportunities - In anti-PD1 failed melanoma patients, RP1 plus Nivolumab achieved an Objective Response Rate (ORR) of 32.9% and a median Duration of Response (mDoR) of 33.7 months[78] - In responders, responses in non-injected lesions occurred with similar frequency and depth as injected lesions, indicating systemic benefit[78] - Patients with deep/visceral (+/- superficial) injections had numerically higher response rates vs those who received superficial injections only[78] - In solid organ transplant patients with locally advanced CSCC, RP1 monotherapy achieved an ORR of 34.6% and a Disease Control Rate (DCR) of 65.4%[220] - In a study of resectable cutaneous Squamous Cell Carcinoma (cSCC), RP1 monotherapy resulted in a 100% overall response rate, with 83% achieving pathological complete response[214] RPx Platform Expansion & Pipeline - The company is planning RPx expansion into additional skin cancers, liver and thoracic primary/metastatic cancers[174] - A confirmatory Phase 3 trial (IGNYTE-3) is underway in melanoma, randomizing patients to RP1 + Nivolumab vs Treatment of Physician's Choice[179] - A registrational REVEAL study is ongoing for RP2 in metastatic Uveal Melanoma, comparing RP2 + Nivolumab to Ipilimumab + Nivolumab[243] - RP2 is being evaluated in liver primary/metastases, including a cohort with RP2 + Bevacizumab + Atezolizumab in 2L PD-(L)1 failed Hepatocellular Carcinoma (HCC)[246] Commercialization & Market Opportunity - The company estimates ~10,000 addressable patients across lines of therapy for RP1 in the US melanoma market[111] - The company estimates RPx has the potential to reach up to ~125,000 patients in the US across various cancer types[251] - The company has hired and trained a commercial organization of ~60 customer-facing team members[108]

Replimune Group (REPL) 2025 Conference Summary Company Overview - **Company**: Replimune Group (REPL) - **Event**: Jefferies 2025 Healthcare Global Conference - **Date**: June 5, 2025 Key Updates and Core Points 1. **Regulatory Progress**: The company is on track for a PDUFA date on July 22, having completed late cycle meetings and manufacturing inspections, with label negotiations forthcoming [11][61][63] 2. **ASCO Data Highlights**: At the ASCO meeting, Replimune presented data showing RP1's systemic activity in visceral lesions, with increased response rates in deep lesions compared to superficial ones, supporting the hypothesis of enhanced patient outcomes [12][14][19] 3. **Safety Profile**: The safety profile of RP1 was emphasized, with no increased bleeding rates from liver injections and manageable pneumothorax from lung injections, which is crucial for physician confidence [13][14] 4. **Commercialization Strategy**: The company is focusing on logistics and biosafety for RP1, indicating that standard cleaning procedures are sufficient for handling the product, which is not classified as an airborne virus [15][16] 5. **Physician Engagement**: Key opinion leaders (KOLs) are shifting their focus to incorporating RP1 into their practices, with a significant portion of patients having deeper lesions that require image guidance for treatment [19][20] 6. **Market Targeting**: Replimune plans to target approximately 350 accounts in the U.S. that treat over half of melanoma patients, with an initial focus on 150 high-volume accounts for rapid adoption [24][46] 7. **Payer Engagement**: The reimbursement model is favorable, with existing procedural codes supporting the use of RP1, and payers recognizing the unmet need in the disease setting [32][33] 8. **Commercial Infrastructure**: The company has established a commercial team of about 60 people, including sales representatives and interventional radiology coordinators, to support the launch and ensure effective communication with healthcare providers [71][72] 9. **Future Expansion Plans**: Replimune is exploring additional indications for RP1, including non-melanoma skin cancers and earlier disease settings, with ongoing trials in uveal melanoma [80][82] Additional Important Insights 1. **Clinical Trial Insights**: The IGNITE study showed a consistent efficacy response across various patient subgroups, reinforcing the potential for a broad label upon approval [66][68] 2. **Interventional Radiology Role**: Interventional radiologists are expected to play a critical role in the treatment process, with a growing interest in active treatment options like RP1 [53][55] 3. **Operational Efficiency**: The company has managed to keep operational expenses (OpEx) in check, with favorable cost of goods sold (COGS) due to in-house manufacturing capabilities [76][78] 4. **Patient-Centric Approach**: The treatment plan allows flexibility in lesion selection and injection sequence, emphasizing a practical approach to patient care [21][29] This summary encapsulates the key points discussed during the Replimune Group conference, highlighting the company's strategic direction, regulatory progress, and market engagement efforts.

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]