प्राथमिक स्रोत रिकॉर्ड
महत्वपूर्णआवेदन स्वीकृत
Replimune: FDA ने RP1 की पुनः प्रस्तुत BLA स्वीकार की, PDUFA तिथि 10 अप्रैल 2026 तय
FDA accepted the BLA resubmission for RP1 plus nivolumab in advanced melanoma and assigned a PDUFA target action date of April 10, 2026. The agency considers the resubmission a complete response to the July 21, 2025 CRL. IGNYTE-3 Phase 3 trial remains ongoing and may support approval.
मुख्य तथ्य
- फाइल किया गया
- 6 नव॰ 2025, 01:20 pm
- घटना
- आवेदन स्वीकृत
- दिशा
- सकारात्मक
- कंपनी
REPLReplimune- संपत्ति
- vusolimogene oderparepvec
- स्रोत
- SEC 8-K
- विश्वसनीयता
- स्रोत सहित
- कैलेंडर
- FDA फ़ैसला (PDUFA) · 2 अग॰ 2026 · पूर्ण प्रतिक्रिया पत्र
स्रोत का अंश
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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