Ultragenyx: DTX401 PDUFA itinakda sa Agosto 23, 2026

Tinanggap ng FDA ang DTX401 BLA para sa GSDIa at nagtalaga ng PDUFA action date na Agosto 23, 2026. Isang pangalawang PDUFA date na Setyembre 19, 2026 ang itinakda rin para sa UX111 BLA sa MPS IIIA. Ang dalawang paparating na action date na ito ang susunod na regulatory milestones para sa gene-therapy pipeline ng kumpanya.

Mahahalagang fact

Na-file: Ago 4, 2026, 08:09 PM
Kaganapan: Naitakda ang petsa ng PDUFA
Direksyon: Neutral
Kumpanya: RAREUltragenyx
Asset: pariglasgene brecaparvovec
Pinagmulan: SEC 8-K
Kumpiyansa: May source
Kalendaryo: Desisyon ng FDA (PDUFA) · Ago 23, 2026 · Walang naitalang resulta

Sipi mula sa source

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 Second Quarter 2026 Financial Results and Corporate Update Second quarter total revenue of $214 million, Crysvita® revenue of $156 million and Dojolvi® revenue of $27 million Reaffirm 2026 financial guidance, including total revenue of $730 million to $760 million and combined R&D and SG&A expenses to be flat to slightly down versus 2025; remain on path to profitability in 2027 Catalysts in second half of 2026 include two PDUFA dates and pivotal data readout from GTX-102 Phase 3 Aspire study for Angelman syndrome NOVATO, Calif. – August 4, 2026 – Ultragenyx Pharmaceutical Inc. (NASDAQ: RAR

SEC 8-K