प्राथमिक स्रोत रिकॉर्ड
महत्वपूर्णPDUFA तारीख़ तय
फोर्ट्रेस बायोटेक: FDA ने CUTX-101 की NDA के लिए PDUFA तिथि 14 जनवरी 2026 तय की
FDA accepted the Class 1 resubmission of the CUTX-101 NDA and assigned a new PDUFA target action date of January 14, 2026. The CRL issued on September 30, 2025 was limited to manufacturing-site cGMP observations; no efficacy or safety deficiencies were cited.
मुख्य तथ्य
- फाइल किया गया
- 15 दिस॰ 2025, 01:30 pm
- घटना
- PDUFA तारीख़ तय
- दिशा
- सकारात्मक
- कंपनी
FBIOFortress Biotech- संपत्ति
- CUTX-101
- स्रोत
- SEC 8-K
- विश्वसनीयता
- स्रोत सहित
- कैलेंडर
- FDA फ़ैसला (PDUFA) · 14 जन॰ 2026 · पूर्ण प्रतिक्रिया पत्र
स्रोत का अंश
EX-99 2 fbio-20251215xex99.htm EX-99 Exhibit 99.1 Fortress Biotech and Cyprium Therapeutics Announce FDA Acceptance of CUTX-101 NDA Resubmission New PDUFA Target Action Date of January 14, 2026 set by FDA Miami, FL – December 15, 2025 – Fortress Biotech, Inc. (Nasdaq: FBIO) (“Fortress”) and its majority-owned subsidiary, Cyprium Therapeutics, Inc. (“Cyprium”), today announced that the U.S. Food and Drug Administration (“FDA”) has accepted the resubmission of the New Drug Application (“NDA”) for CUTX-101 (copper histidinate), intended to treat Menkes disease in pediatric patients. The resubmission has been accepted as a Class 1 resubmission and as a result, the new Prescription Drug User Fee Act (PDUFA) target action date for the NDA is January 14, 2026. In December 2023, Sent
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12 जन॰ 2026
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FBIOFortress Biotech