प्राथमिक स्रोत रिकॉर्ड
महत्वपूर्णआवेदन स्वीकृत
Replimune: FDA ने RP1 BLA के पुनः सबमिशन को स्वीकार किया, PDUFA तिथि 2 अगस्त 2026 तय
FDA accepted the RP1 (vusolimogene oderparepvec) BLA resubmission in combination with nivolumab for advanced melanoma as a complete Class 1 response. The agency assigned a PDUFA goal date of August 2, 2026 and notified the company of an expected advisory committee meeting in late July.
मुख्य तथ्य
- फाइल किया गया
- 29 जून 2026, 12:11 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 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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