Replimune Group, Inc. REPL
Replimune Group, Inc. (Nasdaq: REPL) is an oncology drug developer. Its lead program, TUDRIQEV (vusolimogene oderparepvec-wtpg; RP1) + nivolumab, is in Phase 3 for unresectable advanced cutaneous melanoma after anti-PD-1 progression. Its next catalyst on record is RP2 (HCC): Preliminary HCC data release (2026).
Upcoming catalysts
No catalyst is dated to the next 30 days or to an FDA action date.
Next further out: RP2 (HCC) — Preliminary HCC data release (2026). 3 catalysts on record beyond the next 30 days; subscribers see each with its filing sentence.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| TUDRIQEV (RP1) + nivolumab, anti-PD-1 failed melanoma | advanced cutaneous melanoma | gene therapy | Approved |
| IGNYTE-3 (TUDRIQEV, confirmatory) | anti-PD-1 failed melanoma | gene therapy | Phase 3 |
| RP2 (REVEAL) | metastatic uveal melanoma, checkpoint-naive | gene therapy | Phase 2 |
| TUDRIQEV (non-melanoma skin cancer cohort) | CSCC, MCC, BCC, angiosarcoma | gene therapy | Phase 2 |
| TUDRIQEV (ARTACUS) | skin cancers in solid organ transplant recipients | gene therapy | Phase 2 |
| RP2 (HCC with atezolizumab/bevacizumab; BTC with durvalumab) | hepatocellular carcinoma, biliary tract cancer | gene therapy | Phase 2 |
| RP3 | solid tumors | gene therapy | Phase 1 |
Recent results and decisions
- Aug 6, 2026approval FDA granted accelerated approval of TUDRIQEV plus nivolumab based on ORR 24.2% and median DoR 14.1 months in 91 efficacy-evaluable patients.
This indication is approved under accelerated approval based on objective response rate and duration of response.
Filing - Jul 30, 2026adcomm positive FDA CTGTAC voted 10 to 3 that IGNYTE efficacy results are evaluable and clinically meaningful; FDA action date is August 2, 2026.
Advisory Committee voted 10 to 3 that the efficacy results from the IGNYTE study are evaluable and clinically meaningful
Filing - Jun 29, 2026positive IGNYTE 3-year overall survival analysis (ASCO 2026 oral): 47.8% of treated patients alive at 3 years, median OS 32.9 months, 83.5% 3-year survival among responders.
RP1 plus nivolumab demonstrated exceptional durability in anti-PD-1-failed melanoma patients, with 47.8% of all treated patients alive at 3 years and a median overall survival of 32.9 months
Filing
6 more on record.
For subscribers
- Cash runway against each catalyst, with the company's own runway statement
- Track record: every Phase 3 readout, FDA decision and guidance slip since 2014
- Expected move for each dated catalyst, from comparable past events
- Phase 2 evidence behind each Phase 3 readout
- Companies on the same target or class
- Full catalyst list with filing sentences, deals, registered trials, Excel export
Other phase 3 oncology companies
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- BeOne Medicines Ltd. ONC
- Revolution Medicines, Inc. RVMD
- Genmab A/S GMAB
- BioNTech SE BNTX
- Exelixis, Inc. EXEL
The free Monday brief
Last week's readouts and FDA decisions and the dated catalysts in the week ahead, each with its filing sentence.