Record mula sa primary source
Decision-gradeBoto ng advisory committee
Replimune: bumoto ang FDA AdComm nang 10-3 na ang resulta ng bisa ng IGNYTE ay evaluable at klinikal na makabuluhan
The CTGTAC voted 10 to 3 that the single-arm IGNYTE study efficacy results are evaluable and clinically meaningful for RP1 plus nivolumab in anti-PD-1-progressed advanced melanoma. This positive advisory-committee outcome removes a key regulatory hurdle and supports continued FDA review of the BLA resubmission. The agency’s target action date remains August 2, 2026.
Mahahalagang fact
- Na-file
- Hul 31, 2026, 12:02 AM
- Kaganapan
- Boto ng advisory committee
- Direksyon
- Positibo
- Kumpanya
REPLReplimune- Pinagmulan
- SEC 8-K
- Kumpiyansa
- May source
- Boto ng adcomm
- 10 laban sa 3
Sipi mula sa source
EX-99.1 2 tm2621708d1_ex99-1.htm EXHIBIT 99.1 Exhibit 99.1 Replimune Announces Favorable Outcome of FDA's Cellular, Tissue, and Gene Therapies Advisory Committee Meeting for RP1 in Advanced Melanoma Advisory Committee voted 10 to 3 that the efficacy results from the IGNYTE study are evaluable and clinically meaningful WOBURN, Mass., July 30, 2026 (GLOBE NEWSWIRE) — Replimune Group, Inc. (Nasdaq: REPL), a clinical-stage biotechnology company pioneering the development of novel oncolytic immunotherapies, today announced the outcome of today's meeting of the U.S. Food and Drug Administration's (FDA) Cellular, Tissue, and Gene Therapies Advisory Committee (CTGTAC), which discussed the Biologics License Application (BLA) resubmission for RP1 (vusolimogene oderparepvec) in combination with n
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