1차 출처 기록
중대신청 접수
Ultragenyx, UX111 BLA 재제출에 대해 IRL 수령
The company received an Incomplete Response Letter on its January 2026 resubmitted BLA for UX111, requesting additional CMC documentation. The company plans to provide the requested information in a further resubmission.
핵심 사실
출처 발췌
EX-99.1 2 rare-ex99_1.htm EX-99.1 EX-99.1 Exhibit 99.1 Contacts Ultragenyx Pharmaceutical Inc. Investors Joshua Higa ir@ultragenyx.com Media Jess Rowlands media@ultragenyx.com Ultragenyx Reports Fourth Quarter and Full Year 2025 Financial Results and Corporate Update 2025 total revenue of $673 million, Crysvita® revenue of $481 million and Dojolvi® revenue of $96 million 2026 total revenue from current products expected to be between $730 million to $760 million Initiated a strategic restructuring plan to significantly reduce and focus expenses and headcount, reiterate path to profitability in 2027 2026 catalysts include two potential approvals and expected pivotal Phase 3 data from the GTX-102 Phase 3 Aspire study for Angelman syndrome NOVATO, Calif. – February 12, 2025 – Ultrag