BriefIQ Markets · REPL · 8-K
Favorable 10–3 FDA advisory vote supports RP1 approval prospects, with final FDA action targeted for August 2, 2026
Key Facts
- The FDA’s Cellular, Tissue, and Gene Therapies Advisory Committee voted 10–3 that efficacy results from Replimune’s IGNYTE study of RP1 are evaluable and clinically meaningful.
- The FDA’s target action date for its review of Replimune’s Class 1 BLA resubmission is August 2, 2026; the review was still ongoing as of the filing.
Source
Filing details
- Form
- 8-K
- Symbol
- REPL
- Company
- Replimune Group, Inc.
- CIK
- 0001737953
- Accession number
- 0001104659-26-088857
- SEC filing date
- 2026-07-31
- SEC acceptance time
- 2026-07-31T02:02:23+02:00
- RSS publication time
- 2026-07-31T02:02:23+02:00
- BriefIQ published
- 2026-07-31T10:55:28.365389+00:00
- Reporting period
- 2026-07-30