原始出處紀錄
重大申請已受理
Ultragenyx 收到 UX111 BLA 補件回覆函
該公司收到其 2026 年 1 月重新提交的 UX111 BLA 的不完整回覆函，要求提供額外的 CMC 文件。公司計劃在進一步的重新提交中提供所需資訊。
關鍵事實
來源摘錄
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