Replimune Announces FDA Acceptance of BLA Resubmission of RP1 for the Treatment of Advanced Melanoma
Replimune (NASDAQ: REPL) announced that the U.S. Food and Drug Administration has accepted the BLA resubmission for RP1 in combination with nivolumab to treat advanced melanoma in patients who progress on an anti‑PD‑1 containing regimen.
The FDA set a PDUFA target action date of April 10, 2026 under a Class II resubmission timeline. Replimune said the resubmission includes additional information, data and analyses and that the FDA views it as a complete response to the complete response letter issued in July 2025.
Replimune (NASDAQ: REPL) ha annunciato che la U.S. Food and Drug Administration ha accettato la presentazione BLA per RP1 in combinazione con nivolumab per trattare il melanoma avanzato nei pazienti che progrediscono nonostante un regime contenente anti-PD-1. L'FDA ha fissato una data obiettivo PDUFA del 10 aprile 2026 nell'ambito di una tempistica di riproposizione di Classe II. Replimune ha detto che la ripresentazione include ulteriori informazioni, dati e analisi e che l'FDA la considera una risposta completa alla lettera di risposta completa emessa nel luglio 2025.
Replimune (NASDAQ: REPL) anunció que la Administración de Alimentos y Medicamentos de EE. UU. ha aceptado la presentación de BLA para RP1 en combinación con nivolumab para tratar el melanoma avanzado en pacientes que progresan con un régimen que contiene anti-PD-1. La FDA fijó una fecha objetivo de acción PDUFA del 10 de abril de 2026 dentro de una cronología de re-presentación de Clase II. Replimune indicó que la presentación incluye información adicional, datos y análisis y que la FDA lo considera una respuesta completa a la carta de respuesta completa emitida en julio de 2025.
Replimune (NASDAQ: REPL)은 미국 식품의약국(FDA)이 RP1의 BLA 재제출을 nivolumab과의 병용으로 진행 중인 anti-PD-1 요법에 따라 진행되는 진행성 흑색종 환자 치료에 허용했다고 발표했다. FDA는 PDUFA 목표 조치일 2026년 4월 10일을 Class II 재제출 일정에 따라 설정했다. Replimune은 재제출에 추가 정보, 데이터 및 분석이 포함되며 FDA가 이를 2025년 7월 발행된 완전한 응답 서한에 대한 완전한 응답으로 본다고 말했다.
Replimune (NASDAQ: REPL) a annoncé que la Food and Drug Administration américaine a accepté la réexamen BLA pour RP1 en association avec le nivolumab pour traiter le mélanome avancé chez les patients qui progressent sous un régime contenant anti-PD-1. La FDA a fixé une date cible PDUFA d’action au 10 avril 2026 dans le cadre d’un calendrier de réexamen de Classe II. Replimune a indiqué que le réexamen comprend des informations, des données et des analyses supplémentaires et que la FDA le considère comme une réponse complète à la lettre de réponse complète émise en juillet 2025.
Replimune (NASDAQ: REPL) gab bekannt, dass die US-amerikanische Arzneimittelbehörde die erneute BLA-Einreichung für RP1 in Kombination mit Nivolumab zur Behandlung von fortgeschrittenem Melanom bei Patienten, die auf eine anti-PD-1-haltige Behandlung ansprechen, akzeptiert hat. Die FDA setzte ein PDUFA-Zieltermindatum der Aktion vom 10. April 2026 im Rahmen eines Class-II-Resubmission-Zeitplans. Replimune sagte, die erneute Einreichung umfasse zusätzliche Informationen, Daten und Analysen und dass die FDA sie als vollständige Reaktion auf das vollständige Antwortschreiben vom Juli 2025 betrachtet.
Replimune (NASDAQ: REPL) أعلنت أن إدارة الغذاء والدواء الأمريكية قبلت إعادة تقديم BLA لـ RP1 بالتزامن مع النيفولوماب لعلاج الورم الميلانيني المتقدم لدى المرضى الذين يتقدمون في نظام يحتوي على anti-PD-1. حددت FDA تاريخ إجراء الاستجابة المستهدف PDUFA في 10 أبريل 2026 بموجب جدولة إعادة تقديم من الفئة II. وقالت Replimune إن إعادة التقديم تتضمن معلومات إضافية وبيانات وتحليلات وأن FDA تعتبرها استجابة كاملة لـ رسالة الاستجابة الكاملة الصادرة في يوليو 2025.
Replimune (NASDAQ: REPL)宣布，美国食品药品监督管理局已接受 RP1 的 BLA 重新提交，与 nivolumab 联合用于治疗在含抗 PD-1 的治疗方案中进展的晚期黑色素瘤患者。FDA 在一个 II 类重新提交时间表下设定了 PDUFA 的行动目标日期为 2026 年 4 月 10 日。Replimune 表示，重新提交包含更多信息、数据和分析，FDA 认为这是对 2025 年 7 月发布的完全响应信函的完整回应。
- FDA accepted BLA resubmission for RP1 plus nivolumab
- PDUFA target action date set for April 10, 2026
- Resubmission considered complete response to July 2025 CRL
- Previously received a complete response letter in July 2025
- Approval pathway limited to patients who progress on anti‑PD‑1 therapy
- Review extended to a Class II timeline with action date in 2026
Prescription Drug User Fee Act (PDUFA) target action date set for April 10, 2026
WOBURN, Mass., Oct. 20, 2025 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (NASDAQ: REPL), a clinical stage biotechnology company pioneering the development of novel oncolytic immunotherapies, today announced that the U.S. Food and Drug Administration (FDA) has accepted the resubmission of the Biologics License Application (BLA) for RP1 in combination with nivolumab for the treatment of advanced melanoma in patients who progress on an anti-PD-1 containing regimen. The PDUFA date set by the FDA is April 10, 2026 based on a Class II resubmission timeline.
“We are pleased the agency has accepted the resubmission of our BLA for RP1,” said Sushil Patel, Ph.D., CEO of Replimune. “RP1 plus nivolumab offers a strong risk benefit profile where there are few options for patients with advanced melanoma, who have progressed on PD-1 based therapy. We look forward to working closely with the agency to expedite this review as much as possible for patients’ benefit.”
During the past few months, Replimune has been working to address agency feedback. Additional information, data and analyses were included in the resubmission which will be part of the BLA review. The FDA indicated this resubmission is considered to be a complete response to the complete response letter received in July 2025.
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 the design and sufficiency of our clinical trials and outcomes, and regulatory filings with the FDA, the review and timing of our biologics license application by the FDA, the potential applicability of our product candidates to treat certain indications, 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 sufficient continuous operation of our in-house manufacturing facility to produce the necessary quality and quantity of our product candidates for continuous clinical trial supply, 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
What did Replimune (REPL) announce on October 20, 2025 about RP1?
What is the FDA PDUFA date for RP1 (REPL) after the resubmission?
Does the RP1 BLA resubmission for REPL address prior FDA feedback?
What patient population is RP1 seeking approval for in the REPL BLA?
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