Catatan sumber primer
MaterialPermohonan diterima
Replimune: FDA menerima resubmisi BLA RP1, tetapkan PDUFA 10 April 2026
FDA menerima resubmisi BLA untuk RP1 plus nivolumab pada melanoma lanjut dan menetapkan tanggal aksi target PDUFA 10 April 2026. Badan tersebut menganggap resubmisi sebagai respons lengkap terhadap CRL 21 Juli 2025. Uji coba Fase 3 IGNYTE-3 masih berlangsung dan dapat mendukung persetujuan.
Fakta utama
- Diajukan
- 6 Nov 2025, 13.20
- Peristiwa
- Permohonan diterima
- Arah
- Positif
- Perusahaan
REPLReplimune- Sumber
- SEC 8-K
- Keyakinan
- Bersumber
- Kalender
- Keputusan FDA (PDUFA) · 2 Agu 2026 · Surat tanggapan lengkap
Kutipan sumber
EX-99.1 2 tm2530417d1_ex99-1.htm EXHIBIT 99.1 Exhibit 99.1 Replimune Reports Fiscal Second Quarter 2026 Financial Results and Provides Corporate Update Woburn, MA, November 6, 2025 – Replimune Group, Inc. (Nasdaq: REPL), a clinical stage biotechnology company pioneering the development of novel oncolytic immunotherapies, today announced financial results for the fiscal second quarter ended September 30, 2025 and provided a business update. The Company announced on October 20, 2025, that the U.S. Food and Drug Administration (FDA) has accepted the BLA resubmission of RP1 for the treatment of advanced melanoma with a Prescription Drug User Fee Act (PDUFA) target action date set for April 10, 2026. The resubmission is considered by the FDA to be a complete response to the complete respons
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