Replimune Provides Update Following Type A Meeting with FDA
Replimune (NASDAQ: REPL) has completed a Type A meeting with the FDA on September 16th, 2025, to discuss the Complete Response Letter (CRL) received for their RP1 therapy. The meeting focused on their Biologics License Application (BLA) for RP1 in combination with nivolumab for advanced melanoma treatment.
The company is currently evaluating the FDA's feedback, noting that a path forward under the accelerated approval pathway remains undetermined. CEO Sushil Patel emphasized strong support from the melanoma community and highlighted the unmet need in advanced melanoma treatment, citing positive risk-benefit profile observed in the IGNYTE trial.
Replimune (NASDAQ: REPL) ha concluso un incontro di tipo A con la FDA il 16 settembre 2025 per discutere della Complete Response Letter (CRL) ricevuta per la terapia RP1. L'incontro si è concentrato sull'Application for Biologics License (BLA) per RP1 in combinazione con nivolumab per il trattamento del melanoma avanzato. L'azienda sta attualmente valutando il feedback della FDA, indicando che un percorso sotto la via di approvazione accelerata non è determinato. Il CEO Sushil Patel ha sottolineato il forte supporto della comunità di melanoma e ha evidenziato l'urgenza non soddisfatta nel trattamento del melanoma avanzato, citando il profilo rischio-beneficio positivo osservato nello studio IGNYTE.
Replimune (NASDAQ: REPL) ha celebrado una reunión de tipo A con la FDA el 16 de septiembre de 2025 para analizar la Complete Response Letter (CRL) recibida para su terapia RP1. La reunión se centró en la Biologics License Application (BLA) para RP1 en combinación con nivolumab para el tratamiento del melanoma avanzado. La empresa está evaluando los comentarios de la FDA, señalando que el camino a seguir bajo la vía de aprobación acelerada permanece por determinar. El CEO Sushil Patel destacó el sólido apoyo de la comunidad de melanoma y la necesidad no satisfecha en el tratamiento del melanoma avanzado, citando el perfil riesgo-beneficio positivo observado en el ensayo IGNYTE.
Replimune (NASDAQ: REPL)은 2025년 9월 16일 FDA와의 Type A 회의를 마치고 RP1 치료제에 대한 CRL에 대해 논의했습니다. 회의의 초점은 NIVOLUMAB과의 병용으로 진행된 흑색종 치료를 위한 RP1의 생물학적 제제 허가 신청(BLA)에 있었습니다. 현재 회사는 FDA의 피드백을 검토 중이며 가속 승인 경로 아래의 향후 방향이 아직 결정되지 않았다고 밝혔습니다. CEO Sushil Patel은 흑색종 커뮤니티의 강력한 지지를 강조하고 진행된 흑색종 치료에서의 충족되지 않은 필요성을 강조하였으며, IGNYTE 임상에서 관찰된 긍정적인 위험-편익 프로필을 인용했습니다.
Replimune (NASDAQ: REPL) a terminé une réunion de type A avec la FDA le 16 septembre 2025 pour discuter de la lettre de réponse complète (CRL) reçue pour leur thérapie RP1. La réunion portait sur la Demande de licence biologique (BLA) pour RP1 en combinaison avec le nivolumab dans le traitement du mélanome avancé. L’entreprise évalue actuellement les retours de la FDA, indiquant que la voie vers l’approbation accélérée reste indéterminée. Le PDG Sushil Patel a souligné le fort soutien de la communauté du mélanome et a mis en évidence le besoin non satisfait dans le traitement du mélanome avancé, citant le profil risque-bénéfice positif observé dans l’essai IGNYTE.
Replimune (NASDAQ: REPL) hat am 16. September 2025 ein Type-A-Treffen mit der FDA abgeschlossen, um das Complete Response Letter (CRL) für ihre RP1-Therapie zu besprechen. Das Treffen konzentrierte sich auf den Biologics License Application (BLA) für RP1 in Kombination mit Nivolumab zur Behandlung von fortgeschrittenem Melanom. Das Unternehmen prüft derzeit das Feedback der FDA, wobei unklar bleibt, welchen Weg es im Rahmen des beschleunigten Zulassungsverfahrens gehen wird. CEO Sushil Patel hob die starke Unterstützung der Melanom-Community hervor und betonte den ungedeckten Bedarf in der Behandlung von fortgeschrittenem Melanom, mit Verweis auf das positive Risiko-Nutzen-Profil, das in der IGNYTE-Studie beobachtet wurde.
أكملت شركة Replimune (المدرجة في ناسداك: REPL) اجتماعًا من النوع A مع إدارة الغذاء والدواء الأمريكية في 16 سبتمبر 2025 لمناقشة رسالة الاستجابة الكاملة (CRL) الخاصة بعلاج RP1. ركّز الاجتماع على طلب ترخيص المستحضرات البيولوجية (BLA) لـ RP1 بالاشتراك مع النيفولوماب لعلاج الورم الميلانيني المتقدم. تقوم الشركة حاليًا بتقييم تعليقات FDA، مع الإشارة إلى أن المسار أمامها بموجب مسار الموافقة السريعة ما زال غير محدد. رئيس التنفيذ Sushil Patel أكّد دعم مجتمع الميلانوما القوي وأبرز الحاجة غير الملباة في علاج الميلانوما المتقدم، مشيرًا إلى ملف المخاطر-الفوائد الإيجابي الذي لوحظ في تجربة IGNYTE.
Replimune（纳斯达克：REPL） 已于 2025 年 9 月 16 日与 FDA 完成 Type A 会议，讨论其 RP1 治疗的 CRL。会议重点是 RP1 与 nivolumab 联合用于晚期黑色素瘤治疗的生物制品许可申请（BLA）。公司目前正在评估 FDA 的反馈，指出通过加速审批途径前进的路径尚未确定。首席执行官 Sushil Patel 强调了黑色素瘤社区的强力支持，并强调晚期黑色素瘤治疗中的未满足需求，引用在 IGNYTE 试验中观察到的积极风险-收益特征。
- None.
- No clear path forward under accelerated approval pathway determined
- Complete Response Letter (CRL) indicates FDA's initial rejection of the BLA
- Potential delays in RP1 therapy approval process
WOBURN, Mass., Sept. 18, 2025 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (NASDAQ: REPL), a clinical stage biotechnology company pioneering the development of novel oncolytic immunotherapies, today announced that the company completed a Type A meeting with the U.S. Food and Drug Administration (FDA) on September 16th 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 is evaluating the feedback from the FDA provided during the meeting to determine next steps. At this time, a path forward under the accelerated approval pathway has not been determined.
“The feedback from the melanoma community, including patients and physicians, clearly highlights the unmet need in advanced melanoma and the compelling risk-benefit profile of RP1 observed in the IGNYTE trial,” said Sushil Patel, Ph.D., CEO of Replimune. “We remain committed to working with the FDA to determine an expeditious path forward for RP1.”
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 content of our interactions with the FDA at our Type A Meeting, the outcome and timing of any resolutions following such meeting, the viability of the continuation of our confirmatory trial in advanced melanoma, and other statements identified by words such as “could,” “expects,” “intends,” “hope,” “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, if any, our ability to resolve the issues identified in the CRL and the Type A meeting in a manner satisfactory to the FDA and to us and the timing thereof, 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
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