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महत्वपूर्णPDUFA तारीख़ तय

Ultragenyx: DTX401 की PDUFA तिथि 2026 की तीसरी तिमाही के लिए निर्धारित

BLA rolling submission for DTX401 was completed in December 2025. The FDA has now assigned a PDUFA target action date in the third quarter of 2026, establishing a clear regulatory timeline for potential approval of this AAV gene therapy for GSDIa.

मुख्य तथ्य

फाइल किया गया
12 जन॰ 2026, 12:45 pm
घटना
PDUFA तारीख़ तय
दिशा
सकारात्मक
कंपनी
RAREUltragenyx
संपत्ति
pariglasgene brecaparvovec
स्रोत
SEC 8-K
विश्वसनीयता
स्रोत सहित
कैलेंडर
FDA फ़ैसला (PDUFA) · 23 अग॰ 2026 · परिणाम दर्ज नहीं

स्रोत का अंश

EX-99.1 2 rare-ex99_1.htm EX-99.1 EX-99.1 Ultragenyx Provides Financial and Business Updates at J.P. Morgan Annual Healthcare Conference Preliminary 2025 total revenue of $672 million to $674 million, exceeding top end of guidance Preliminary cash and investments of approximately $735 million as of December 31, 2025 Anticipated 2026 catalysts include two potential approvals and pivotal Phase 3 data from the GTX-102 Phase 3 Aspire study for Angelman syndrome NOVATO, Calif. – January 12, 2026 – Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE), a biopharmaceutical company focused on the development and commercialization of novel therapies for serious rare and ultra-rare genetic diseases, today reported preliminary unaudited 2025 revenue results, cash and investments at year end 2025, and p

SEC 8-K

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