Drugs / RP1
RP1
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed CDK4 linked melanoma 2 milestones | |||||
| Filed | US (FDA) | — | CDK4 linked melanoma | 2026-06-26 | “The Company recently announced that the U.S. Food and Drug Administration (FDA) has accepted for review the resubmission of the Biologics License Application (BLA) for RP1...” replimune.com ↗ |
| Filed | US (FDA) | — | CDK4 linked melanoma | 2025-01-21 | “The Company's Biologics License Application (BLA) resubmission for RP1 (vusolimogene oderparepvec) in anti-PD-1 failed melanoma was accepted by the FDA in October 2025.” replimune.com ↗ “After a collaborative dialogue and productive engagement with the FDA we are encouraged by the acceptance of our BLA resubmission for RP1 in combination with nivolumab” replimune.com ↗ “U.S. Food and Drug Administration (FDA) recently accepted the Biologics License Application (BLA) for RP1 plus nivolumab in advanced melanoma for priority review” replimune.com ↗ “FDA has accepted the Biologics License Application (BLA) for RP1 (vusolimogene oderparepvec) in combination with nivolumab for patients with advanced melanoma.” replimune.com ↗ |
| Filed melanomatosis 1 milestone | |||||
| Filed | US (FDA) | — | melanomatosis | 2024-11-21 | “today announced that it has submitted a biologics license application (BLA) to the FDA for RP1 (vusolimogene oderparepvec) in combination with nivolumab for the treatment of...” replimune.com ↗ |
Trials 6
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/23 trials | ||||||
| Phase 1/2 | NCT06067061 | Apr 2024 → May 2025 | triple-negative breast carcinoma | Institut Curie | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1/2 | NCT05858229 | Jun 2023 → Dec 2025 overdue | skin squamous cell carcinoma | Sherrif Ibrahim | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT04349436 | May 2020 → Jul 2029 expected | basal cell carcinoma, cutaneous neuroendocrine carcinoma, skin squamous cell carcinoma | Replimune, Inc. | Active not recruiting | No outcome recorded |
| Phase 22 trials | ||||||
| Phase 2 | NCT04050436 | Oct 2019 → Sep 2025 overdue | skin squamous cell carcinoma | Replimune, Inc. | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03767348 | Sep 2017 → Jun 2028 expected | cutaneous melanoma, non-small cell lung carcinoma, skin carcinoma | Replimune, Inc. | Active not recruiting | No outcome recorded |
| Phase not stated1 trial | ||||||
| — | NCT06590480 | — | melanoma | Replimune, Inc. | No longer available | No outcome recorded |
News releases announcing trial results or a regulatory action · 22
| Date | Issuer | Release |
|---|---|---|
| 2026-08-06 | Replimune, Inc. | Regulatory Replimune Announces FDA Accelerated Approval of TUDRIQEVTM in Combination with Nivolumab for Unresectable Advanced Cutaneous Melanoma After Progression on an anti-PD-1 Based Regimen replimune.com ↗
This indication is approved under accelerated approval based on objective response rate and duration of response. |
| 2026-07-30 | Replimune, Inc. | Regulatory Replimune Announces Favorable Outcome of FDA's Cellular, Tissue, and Gene Therapies Advisory Committee Meeting for RP1 in Advanced Melanoma replimune.com ↗
The committee then voted 10 to 3, on the question: “Are the efficacy results from IGNYTE evaluable and clinically meaningful?” |
| 2026-06-26 | Replimune, Inc. | Regulatory Replimune Announces FDA Acceptance of RP1 Biologics License Application Resubmission for Advanced Melanoma replimune.com ↗
The FDA considers this a complete, class 1 response with a goal date of August 2, 2026, and has notified the company to expect an advisory committee meeting in late July. |
| 2026-05-30 | Replimune, Inc. | Results Replimune Presents 3-Year Landmark Overall Survival Analysis from IGNYTE Clinical Trial During Oral Presentation at the 2026 American Society of Clinical Oncology Annual Meeting replimune.com ↗
RP1 (vusolimogene oderparepvec) plus nivolumab achieved a median overall survival (mOS) of 32.9 months in patients with anti–PD-1–failed advanced melanoma, a population with limited treatment options. |
| 2026-05-29 | Replimune, Inc. | Regulatory Replimune Announces Planned RP1 BLA Resubmission Following Productive Discussion with FDA replimune.com ↗
The FDA has indicated it will treat the BLA resubmission as an urgent matter upon receipt and will prioritize its review in recognition of the significant unmet need for patients in the advanced melanoma community. |
| 2026-04-10 | Replimune, Inc. | Regulatory Replimune Receives Complete Response Letter from the FDA for RP1 Biologics License Application for the Treatment of Advanced Melanoma replimune.com ↗
the company received a complete response letter (CRL) from the U.S. Food and Drug Administration (FDA) for the Company’s Biologics License Application (BLA) for RP1 in combination with nivolumab for the treatment of advanced melanoma. |
| 2025-10-20 | Replimune, Inc. | Regulatory Replimune Announces FDA Acceptance of BLA Resubmission of RP1 for the Treatment of Advanced Melanoma replimune.com ↗
“We are pleased the agency has accepted the resubmission of our BLA for RP1,” said Sushil Patel, Ph.D., CEO of Replimune. |
| 2025-10-19 | Replimune, Inc. | Results Replimune Highlights Acral Melanoma Data for RP1 plus Nivolumab at the ESMO Congress 2025 replimune.com ↗
The analysis of acral melanoma patients from the IGNYTE clinical trial showed treatment with RP1 combined with nivolumab resulted in an objective response rate of 44% (8/18) with a median duration of response of 11.9 months (3.9, not reached). |
| 2025-07-22 | Replimune, Inc. | Regulatory Replimune Receives Complete Response Letter from FDA for RP1 Biologics License Application for the Treatment of Advanced Melanoma replimune.com ↗
WOBURN, Mass., July 22, 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 issued a Complete Response Letter (CRL) regarding the Biologics License Application (BLA) for RP1 (vusolimogene oderparepvec) in combination with nivolumab for the treatment of advanced melanoma. |
| 2025-06-01 | Replimune, Inc. | Results Replimune Presents New Analyses from the IGNYTE Study of RP1 plus Nivolumab in Anti-PD1 Failed Melanoma at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting replimune.com ↗
Deep/visceral injections, including into the liver and lung, resulted in numerically higher rates of response compared to superficial injections only and were generally well tolerated |
| 2025-01-21 | Replimune, Inc. | Regulatory Replimune Announces Biologics License Application Acceptance and Priority Review for RP1 for the Treatment of Advanced Melanoma replimune.com ↗
The FDA granted the BLA Priority Review with a Prescription Drug User Fee Act (PDUFA) action date of July 22, 2025. |
| 2024-11-21 | Replimune, Inc. | Regulatory Replimune Receives Breakthrough Therapy Designation for RP1 and Submits RP1 Biologics License Application to the FDA under the Accelerated Approval Pathway replimune.com ↗
The Company also announced that the FDA has granted Breakthrough Therapy designation to RP1 in combination with nivolumab in the same setting. |
| 2024-09-15 | Replimune, Inc. | Results Replimune Presents Primary Analysis Data from IGNYTE Clinical Trial of RP1 Combined with Nivolumab in Anti-PD1 Failed Melanoma at European Society for Medical Oncology (ESMO) Congress 2024 replimune.com ↗
Injected and non-injected lesions responded with similar frequency, depth, duration and kinetics |
| 2023-06-03 | Replimune, Inc. | Results Replimune Presents RP1 Data from the IGNYTE anti-PD1 Failed Melanoma Cohort and RP2 Data in Uveal Melanoma at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting replimune.com ↗
Updated data from ongoing IGNYTE anti-PD1 failed melanoma cohort shows RP1 combined with nivolumab continues to demonstrate deep and durable responses with a well-tolerated safety profile; no progression in responding patients since the data snapshot presented in December 2022 |
| 2022-12-07 | Replimune, Inc. | Results Replimune Announces Positive Initial Data from the Anti-PD1 Failed Melanoma Cohort of the IGNYTE Clinical Trial & an RP2/3 Program Update replimune.com ↗
RP1 combined with nivolumab continues to demonstrate deep and durable responses in patients with anti-PD1 failed melanoma |
| 2022-03-30 | Replimune, Inc. | Results Replimune Provides New Clinical Data, Broad Program Update and Future Development Strategy for its Tumor-Directed Oncolytic Immunotherapies replimune.com ↗
Additionally, the Company announced new data from the ongoing clinical trial in anti-PD1 failed NMSC and from the ARTACUS clinical trial, a Phase 1b/2 trial of RP1 (vusolimogene oderparepvec) as monotherapy in solid organ transplant recipients with skin cancer. |
| 2021-06-03 | Replimune, Inc. | Results Replimune Provides Data Update from its RP1 (vusolimogene oderparepvec) and RP2 Programs and Announces Plans to Expand the Development of RP2/3 Beyond Phase 1 replimune.com ↗
At the current data cut off (n=15), seven of the nine responses are complete responses with a current CR rate of 46% and overall response rate (ORR) of 60%. |
| 2021-04-12 | Replimune, Inc. | Results Replimune to Present New Biomarker & Pre-clinical Data for Lead Oncolytic Immunotherapy Programs at the 2021 American Association for Cancer Research Annual Meeting replimune.com ↗ |
| 2020-06-03 | Replimune, Inc. | Results Replimune Reports Fiscal Fourth Quarter and Full Year 2020 Financial Results and Provides Corporate Update replimune.com ↗
Today we released additional data with RP1 in our lead indications of cutaneous squamous cell carcinoma (CSCC) and anti-PD1 refractory cutaneous melanoma |
| 2020-06-03 | Replimune, Inc. | Results Replimune Provides RP1 Data Update from its Phase 2 Cohorts in Melanoma and Non-Melanoma Skin Cancer that Strongly Support Replimune’s Ongoing Registration-Directed Clinical Trials with RP1 replimune.com ↗
today announced new interim data presented from the Phase 2 part of its Phase 1/2 clinical trial of RP1 in combination with Opdivo® that continues to provide strong support for its lead indications of cutaneous squamous cell carcinoma (CSCC) and anti-PD-1 refractory melanoma. |
| 2019-11-08 | Replimune, Inc. | Results Replimune Presents Initial Clinical Data with RP1 that Strongly Supports Expansion of Clinical Programs in Melanoma and Cutaneous Squamous Cell Carcinoma (CSCC) replimune.com ↗
The data demonstrates that RP1 alone and in combination with Opdivo is well tolerated, with clear anti-tumor activity, and confirms the mechanism of action of RP1 alone and in combination with Opdivo. |
| 2018-09-06 | Replimune, Inc. | Regulatory Replimune Announces FDA Acceptance of Investigational New Drug Application for its Lead Oncolytic Immunotherapy Candidate, RP1 replimune.com ↗
today announced the U.S. Food and Drug Administration (FDA) has accepted the Company’s investigational new drug (IND) application for its lead product candidate, RP1, for patients with solid tumors. |
All press releases naming this drug 22 releases
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 7 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | RP1 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03767348 ↗ |
| Known as | Immulytic | “Atezolizumab plus RP1 (Immulytic™) oncolytic immunotherapy” NCT06067061 ↗ |
| Known as | vusolimogene oderparepvec | “RP1 (vusolimogene oderparepvec) is a herpes simplex virus type 1-based oncolytic immunotherapy” PMID 40627813 ↗ Jul 20251“Vusolimogene Oderparepvec” NCT06067061 ↗ |
| Route | Other | “RP1 was administered intratumorally” PMID 40627813 ↗ Jul 2025 |