secwatch.observer — SEC 8-K summary
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Issuer:     Replimune Group, Inc. (REPL)
CIK:        0001737953
Form:       8-K
Filed at:   2026-08-14T12:10:29+00:00
Accession:  0001104659-26-096483
Event type: other_material
Sentiment:  positive
Materiality: 1.00
Item codes: 2.02, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Replimune wins FDA accelerated approval for TUDRIQEV melanoma combo; Q1 net loss $69.8M
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- FDA granted accelerated approval for TUDRIQEV (RP1) plus nivolumab in advanced melanoma; launch within 60 days.
- Completed $150M financing; net proceeds $141M; cash and equivalents $195.3M as of June 30, 2026.
- Q1 FY2027 net loss $69.8M vs $86.7M; R&D $49.3M, SG&A $19.0M.
- Michelle DiNapoli appointed Chief Commercial Officer, effective Aug 18, 2026; ex-Deciphera.
- IGNYTE-3 confirmatory trial readout expected 2030; REVEAL Phase 2/3 for RP2 enrolling.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1737953/000110465926096483/0001104659-26-096483-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1737953/000110465926096483/tm2623208d1_8k.htm
  HTML page:      https://secwatch.observer/filing/0001104659-26-096483

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer