Replimune Group, Inc.
REPL evidence brief
What we can confirm
- BioSniper Score:
- 4.9 / 10
- Market Cap:
- $1.39B
- Cash Runway:
- 7.8 mo
What it means
What to watch
Prepared research question
What matters most for REPL—catalysts, financial risk and supporting evidence?
Traceable citations · Unknowns marked
BioSniper AI · REPL
Replimune Group, Inc. (REPL) is a commercial-stage biotechnology company developing oncolytic immunotherapies, with its first product, RP1 (vusolimogene oderparepvec) in combination with nivolumab, receiving FDA accelerated approval in August 2026.
Key risk: Commercial execution risk
BioSniper Score
Based on 5 of 6 signals
Financial data as of Jun 30, 2026.
Tracking 3 pipeline candidates · 23 clinical trials for Replimune Group, Inc..
Replimune Group, Inc. (REPL) is a commercial-stage biotechnology company developing oncolytic immunotherapies, with its first product, RP1 (vusolimogene oderparepvec) in combination with nivolumab, receiving FDA accelerated approval in August 2026.
- Replimune reported cash & equivalents of $185.4M as of 2026-06-30 [sec].
- Net income was -$69.8M for the period ended 2026-06-30 [sec].
- Shareholders' equity stood at $105.6M as of 2026-06-30 [sec].
- RP1 (vusolimogene oderparepvec) in combination with nivolumab received FDA accelerated approval in August 2026 [news · published 2026-08-14].
- The company has multiple pipeline candidates: RP1 (Phase 3 for advanced melanoma and angiosarcoma), RP2 (Phase 3 for hepatocellular carcinoma and gastric adenocarcinoma), and RP3 (Phase 1) [pipeline].
What works
- RP1 in combination with nivolumab received FDA accelerated approval, enabling commercial launch within 60 days [news · published 2026-08-14].
- The company recently completed financing to extend cash runway to support commercial launch and confirmatory trial [news · published 2026-08-14].
- Replimune has a partnership with Bristol Myers Squibb for a non-exclusive, royalty-free license to nivolumab for use with RP1 [pipeline].
What to weigh
- The company reported a net loss of -$69.8M as of 2026-06-30 [sec].
- RP1's BLA required multiple resubmissions, with an initial target action date of April 10, 2026, and an FDA AdCom in late July 2026 before the August 2, 2026 decision [news · published 2026-06-30][news · published 2026-02-03].
- The company is still in early stages for most pipeline candidates, with RP2 and RP3 in Phase 1/2/3 and no approved products beyond RP1 [pipeline].
From the filings
Quoted directly from source documents.
RP1 received FDA accelerated approval in August 2026.
“TUDRIQEV™ in combination with nivolumab receives FDA accelerated approval and will launch within 60 days”
News · August 14, 2026
Bristol Myers Squibb collaboration terms for RP1.
“BMS has granted us a non-exclusive, royalty-free license to, and is supplying at no cost, its anti-PD-1 therapy, nivolumab, for use in combination with RP1.”
Catalyst timeline
- 2019-10-08 · Phase2_Start: Phase2_Start: A Randomized, Controlled, Open-Label, Phase 2 Study of Cemiplimab as a Single Agent and in Combination With RP1 in Patients With Advanced Cutaneous Squamous Cell Carcinoma — Phase 2 study of RP1 in combination with cemiplimab for cutaneous squamous cell carcinoma.
- 2019-10-17 · Phase1_Start: Phase1_Start: An Open-Label, Multicenter, Phase 1 Study of RP2 as a Single Agent and in Combination With PD1 Blockade in Patients With Solid Tumors — Phase 1 study of RP2 as monotherapy and with PD-1 blockade.
- 2020-12-04 · Phase3_Start: Phase3_Start: Phase 3 Randomized, Controlled Study of AAV5-hRKp.RPGR for the Treatment of X-linked Retinitis Pigmentosa Associated With Variants in the RPGR Gene — Phase 3 study for a gene therapy candidate (not RP1/RP2).
- 2020-12-29 · Phase1_Start: Phase1_Start: An Open-Label, Multicenter, Phase 1 Study of RP3 as a Single Agent and in Combination With PD-1 Blockade in Patients With Solid Tumors — Phase 1 study of RP3 as monotherapy and with PD-1 blockade.
- 2025-10-20 · AdCom: AdCom: RP1 in combination with nivolumab — FDA Advisory Committee meeting for RP1 in combination with nivolumab.
- 2026-01-30 · Phase2 _Start: Phase2_Start: An Open-Label, Multicenter, Phase 2 Study With Safety Lead-In of Intratumoral Vusolimogene Oderparepvec (VO) in Combination With Pembrolizumab in Patients With Angiosarcoma — Phase 2 study of RP1 (vusolimogene oderparepvec) with pembrolizumab for angiosarcoma.
- 2026-04-01 · Phase2_Start: Phase2_Start: Phase II Study of Neoadjuvant RP2 in Combination With Preoperative Flot for Patients With Stage II or Higher, Non-metastatic Gastroesophageal Adenocarcinoma — Phase 2 study of RP2 with FLOT for gastroesophageal adenocarcinoma.
- 2026-04-10 · PDUFA: PDUFA: RP1 — PDUFA target action date for RP1 (later superseded by August 2, 2026).
- 2026-08-11 · Phase2_Start: Phase2_Start: A Phase 2 Study of RP2 With Tivozanib in Patients With Metastatic Renal Carcinoma After Progression to Immunotherapy — Phase 2 study of RP2 with tivozanib for metastatic renal carcinoma.
Risks & what to watch (4)›
Key risks
- Commercial execution risk — RP1 launch within 60 days requires successful commercial infrastructure; Michelle DiNapoli appointed as CCO [news · published 2026-08-14].
- Confirmatory trial requirement — Accelerated approval likely requires a confirmatory trial; failure could impact continued approval [news · published 2026-08-14].
- Pipeline dependency on RP1 — Only RP1 is approved; RP2 and RP3 are in early-to-mid stages with no guarantee of success [pipeline].
- Financial sustainability — Net loss of -$69.8M as of 2026-06-30; cash runway extended but ongoing losses may require further financing [sec].
What to watch
- Commercial launch of RP1 (TUDRIQEV) within 60 days from August 14, 2026 [news · published 2026-08-14].
- FDA AdCom meeting for RP1 in late July 2026 ahead of the August 2, 2026 decision [news · published 2026-06-30].
- Confirmatory trial design and initiation for RP1 to maintain accelerated approval [news · published 2026-08-14].
- Progress of RP2 Phase 3 trials in hepatocellular carcinoma and gastric adenocarcinoma [pipeline].
Sources: Catalysts · News · Pipeline · Generated October 4, 2026 · How we verify sources →
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Evidence & data
Score breakdownBased on 5 of 6 signals · derived from public data
7.8 months
D/E 1.39 · 0% dilution
Lead: Phase 3
3 candidates
No upcoming catalysts tracked
2 buys · 12 sells (180d)
Runway
Pipeline
Regulatory
Financials
Short Interest
as of Apr 19, 2026- % of float
- 35.5%
- Days to cover
- 10.2
- Shares short
- 16,335,211
- Daily short volume
- -
Short percent of float and days-to-cover reflect reported short positioning. Daily short volume is the exchange-reported short share of a single day's trading volume and is noisier. See the most-shorted biotech ranking →
REPL short interestGovernance
Frequently asked questions
What is the AI investment thesis for Replimune Group, Inc.?
Replimune Group, Inc. (REPL) is a commercial-stage biotechnology company developing oncolytic immunotherapies, with its first product, RP1 (vusolimogene oderparepvec) in combination with nivolumab, receiving FDA accelerated approval in August 2026.
What is Replimune Group, Inc.'s lead drug candidate?
Replimune Group, Inc.'s most advanced tracked candidate is rp1 (Phase 3) for Advanced Melanoma; Cutaneous Squamous Cell Carcinoma.
Who is the CEO of Replimune Group, Inc.?
Dr. Sushil Patel Ph.D. is the chief executive officer of Replimune Group, Inc. (REPL).
Where is Replimune Group, Inc. headquartered?
Replimune Group, Inc. (REPL) is headquartered in Woburn, MA, United States.
What therapeutic areas does Replimune Group, Inc. focus on?
Replimune Group, Inc. develops therapies across Oncology, Gene Therapy, Immunology, Ophthalmology, Dermatology, Nephrology.
The AI overview and BioSniper Score are neutral, data-derived signals built from public SEC filings, ClinicalTrials.gov and FDA records — not investment advice.