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MaterialPermohonan diterima
Replimune: FDA menerima resubmisi BLA RP1, tetapkan PDUFA 2 Agustus 2026
FDA menerima resubmisi BLA RP1 (vusolimogene oderparepvec) dalam kombinasi dengan nivolumab untuk melanoma lanjut sebagai respons Kelas 1 yang lengkap. Badan tersebut menetapkan tanggal target PDUFA 2 Agustus 2026 dan memberitahu perusahaan tentang pertemuan komite penasihat yang diharapkan pada akhir Juli.
Fakta utama
- Diajukan
- 29 Jun 2026, 12.11
- 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 tm2619129d1_ex99-1.htm EXHIBIT 99.1 Exhibit 99.1 Replimune Reports Fiscal Fourth Quarter and Year End 2026 Financial Results and Provides Corporate Update Woburn, MA, June 29, 2026 – Replimune Group, Inc. (Nasdaq: REPL), a clinical stage biotechnology company pioneering the development of novel oncolytic immunotherapies, today announced financial results for the fiscal fourth quarter and year ended March 31, 2026 and provided a business update. The Company recently announced that the U.S. Food and Drug Administration (FDA) has accepted for review the resubmission of the Biologics License Application (BLA) for RP1 (vusolimogene oderparepvec) in combination with nivolumab for the treatment of advanced melanoma. The FDA considers this a complete, class 1 response with a goal dat
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