Replimune Announces Type A Meeting Scheduled with FDA
Replimune (NASDAQ:REPL) has scheduled a Type A meeting with the FDA to discuss the Complete Response Letter (CRL) received for their RP1 melanoma treatment BLA. The company has submitted a briefing book addressing CRL points, including prior agreements on patient population, PD-1 resistance criteria, and component contribution analysis.
CEO Sushil Patel emphasized the urgent need for RP1 in advanced melanoma treatment, supported by physicians and patient advocacy groups. However, the company warned that without accelerated approval, continuing the RP1 program in advanced melanoma, including the phase 3 confirmatory trial, would not be viable.
Replimune (NASDAQ:REPL) ha fissato un incontro di tipo A con la FDA per discutere la Complete Response Letter (CRL) ricevuta riguardo la BLA per il trattamento del melanoma con RP1. L’azienda ha presentato un briefing book che affronta i punti sollevati nella CRL, inclusi gli accordi precedenti sulla popolazione di pazienti, i criteri di resistenza a PD‑1 e l’analisi del contributo dei componenti.
Il CEO Sushil Patel ha sottolineato la grave necessità di RP1 nel trattamento del melanoma avanzato, supportata da medici e associazioni di pazienti. Tuttavia, la società ha avvertito che, senza l’approvazione accelerata, proseguire il programma RP1 nel melanoma avanzato, compreso lo studio di conferma di fase 3, non sarebbe fattibile.
Replimune (NASDAQ:REPL) ha programado una reunión de Tipo A con la FDA para tratar la Complete Response Letter (CRL) recibida sobre la BLA de RP1 para melanoma. La compañía presentó un briefing book que responde a los puntos de la CRL, incluyendo los acuerdos previos sobre la población de pacientes, los criterios de resistencia a PD‑1 y el análisis de contribución de los componentes.
El CEO Sushil Patel destacó la necesidad urgente de RP1 en el tratamiento del melanoma avanzado, apoyada por médicos y grupos de defensa de pacientes. Sin embargo, la empresa advirtió que, sin una aprobación acelerada, continuar con el programa RP1 en melanoma avanzado, incluido el ensayo confirmatorio de fase 3, no sería viable.
Replimune (NASDAQ:REPL)는 RP1 흑색종 치료제 BLA에 대해 수령한 Complete Response Letter(CRL)을 논의하기 위해 FDA와 Type A 미팅을 예정했습니다. 회사는 환자군, PD‑1 내성 기준, 구성요소 기여도 분석 등 CRL 지적사항을 다룬 브리핑북을 제출했습니다.
CEO 수실 패텔은 의사들과 환자 옹호단체들이 지지하는 진행성 흑색종 치료에 대한 RP1의 시급한 필요성
Replimune (NASDAQ:REPL) a programmé une réunion de type A avec la FDA pour discuter de la Complete Response Letter (CRL) reçue concernant la BLA de RP1 pour le mélanome. La société a soumis un briefing book traitant les points de la CRL, notamment les accords antérieurs sur la population de patients, les critères de résistance au PD‑1 et l’analyse de la contribution des composants.
Le PDG Sushil Patel a souligné le besoin urgent de RP1 dans le traitement du mélanome avancé, soutenu par les médecins et les associations de patients. Cependant, la société a averti que sans approbation accélérée, poursuivre le programme RP1 dans le mélanome avancé, y compris l’essai confirmatoire de phase 3, ne serait pas viable.
Replimune (NASDAQ:REPL) hat ein Type‑A-Meeting mit der FDA angesetzt, um das erhaltene Complete Response Letter (CRL) zur RP1‑Melanom‑BLA zu besprechen. Das Unternehmen hat ein Briefing‑Book vorgelegt, in dem die CRL‑Punkte behandelt werden, darunter frühere Vereinbarungen zur Patientenpopulation, zu PD‑1‑Resistenzkriterien und zur Analyse des Beitrag der Komponenten.
CEO Sushil Patel betonte den dringenden Bedarf an RP1 in der Behandlung des fortgeschrittenen Melanoms, unterstützt von Ärzten und Patientenvertretungen. Das Unternehmen warnte jedoch, dass ohne eine beschleunigte Zulassung die Fortführung des RP1‑Programms beim fortgeschrittenen Melanom, einschließlich der Phase‑3‑Bestätigungsstudie, nicht tragfähig wäre.
- Company has secured a Type A meeting with FDA to discuss CRL
- Briefing book addresses key points from CRL with additional data analysis
- Strong support from melanoma community and physicians for RP1 treatment
- Risk of RP1 melanoma program discontinuation without accelerated approval
- Current BLA faces regulatory challenges requiring resolution
- Phase 3 confirmatory trial viability depends on accelerated approval
WOBURN, Mass., Sept. 02, 2025 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (Nasdaq: REPL), a clinical stage biotechnology company pioneering the development of novel oncolytic immunotherapies, today announced that a Type A meeting with the U.S. Food and Drug Administration (FDA) has been scheduled to discuss the complete response letter (CRL) for the Company’s Biologics License Application (BLA) for RP1 in combination with nivolumab for the treatment of advanced melanoma.
The Company submitted a briefing book to the FDA addressing the points from the CRL, highlighting prior agreements related to the patient population, criteria for PD-1 resistance, and use of literature to support contribution of components. The briefing book also includes an additional analysis of data from the BLA and addresses comments about the phase 3 confirmatory trial design.
“We are eager to engage in a productive discussion with the FDA to reach a swift resolution for the accelerated approval of RP1 in advanced melanoma,” said Sushil Patel, Ph.D., CEO of Replimune. “The melanoma community, including leading physicians and patient advocacy groups have emphasized the urgent need for access to RP1 based on the strength of the data and limited effective treatment options for this population. We remain steadfastly committed to patient access while we work with the FDA to secure regulatory approval for RP1, however, without accelerated approval based on the current application, continuation of the RP1 program in advanced melanoma, including the phase 3 confirmatory trial, will not be viable.”
About RP1
RP1 (vusolimogene oderparepvec) is Replimune’s lead product candidate and is based on a proprietary strain of herpes simplex virus engineered and genetically armed with a fusogenic protein (GALV-GP R-) and GM-CSF intended to maximize tumor killing potency, the immunogenicity of tumor cell death, and the activation of a systemic anti-tumor immune response.
About Replimune
Replimune Group, Inc., headquartered in Woburn, MA, was founded in 2015 with the mission to transform cancer treatment by pioneering the development of novel oncolytic immunotherapies. Replimune’s proprietary RPx platform is based on a potent HSV-1 backbone intended to maximize immunogenic cell death and the induction of a systemic anti-tumor immune response. The RPx platform is intended to ignite local activity consisting of direct selective virus-mediated killing of the tumor resulting in the release of tumor derived antigens and altering of the tumor microenvironment to then activate a strong and durable systemic response. The RPx product candidates are expected to be synergistic with most established and experimental cancer treatment modalities, leading to the versatility to be developed alone or combined with a variety of other treatment options. For more information, please visit www.replimune.com.
Forward Looking Statements
This press release contains forward looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, including statements regarding our expectations about our cash runway, the status of the FDA review or interactions following the complete response letter, the design and advancement of our clinical trials, the timing and sufficiency of our clinical trial outcomes to support potential approval of any of our product candidates, the regulatory review process and timing of potential product approval, our goals to develop and commercialize our product candidates, patient enrollments in our existing and planned clinical trials and the timing thereof, and other statements identified by words such as “could,” “expects,” “intends,” “may,” “plans,” “potential,” “should,” “will,” “would,” or similar expressions and the negatives of those terms. Forward-looking statements are not promises or guarantees of future performance, and are subject to a variety of risks and uncertainties, many of which are beyond our control, and which could cause actual results to differ materially from those contemplated in such forward-looking statements. These factors include risks related to our limited operating history, our ability to generate positive clinical trial results for our product candidates, the costs and timing of operating our in-house manufacturing facility, the timing and scope of regulatory approvals, the availability of combination therapies needed to conduct our clinical trials, changes in laws and regulations to which we are subject, competitive pressures, our ability to identify additional product candidates, political and global macro factors including the impact of a global pandemic and related public health issues and the ongoing political and military conflicts, including trade conflicts, and other risks as may be detailed from time to time in our Annual Reports on Form 10-K and Quarterly Reports on Form 10-Q and other reports we file with the Securities and Exchange Commission. Our actual results could differ materially from the results described in or implied by such forward-looking statements. Forward-looking statements speak only as of the date hereof, and, except as required by law, we undertake no obligation to update or revise these forward-looking statements.
Investor Inquiries
Chris Brinzey
ICR Healthcare
339.970.2843
chris.brinzey@icrhealthcare.com
Media Inquiries
Arleen Goldenberg
Replimune
917.548.1582
media@replimune.com
FAQ
What is the status of Replimune's (REPL) RP1 melanoma treatment FDA approval?
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What has Replimune submitted to the FDA regarding the RP1 CRL?
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