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Ultragenyx menerima IRL atas resubmisi BLA UX111

Perusahaan menerima Incomplete Response Letter atas BLA yang diajukan ulang pada Januari 2026 untuk UX111, yang meminta dokumentasi CMC tambahan. Perusahaan berencana menyediakan informasi yang diminta dalam pengajuan ulang berikutnya.

Fakta utama

Diajukan
12 Feb 2026, 21.11
Peristiwa
Permohonan diterima
Arah
Netral
Perusahaan
RAREUltragenyx
Aset
UX111
Sumber
SEC 8-K
Keyakinan
Bersumber

Kutipan sumber

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

SEC 8-K

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