Ultragenyx Q2 FY26: Revenue +28% to $214.0M, net loss narrows 20% to -$92.0M; two BLAs under review

Filed August 5, 2026 · Period ending June 30, 2026 · Compared to 10-Q Aug 6, 2025 · ~2 min read

Key Changes

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  DTX401 (GSDIa gene therapy) and UX111 (Sanfilippo A gene therapy) BLAs accepted for Priority Review with PDUFA dates Aug 23 and Sep 19, 2026; FDA indicated no Advisory Committee meeting anticipated for DTX401.

  MD&A: Regulatory Milestones verify on EDGAR →
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  Feb 2026 restructuring reduced workforce 10% and curtailed UX143 manufacturing, incurring $30M in charges (all cash-settled by June 30); follows Dec 2025 announcement that UX143 Phase 3 studies missed primary fracture-reduction endpoint.

  MD&A: Restructuring; Notes verify on EDGAR →
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  Dojolvi launched in Japan in May 2026 following March approval and NHI drug-price listing; new U.S. Patent No. 12,551,461 (expires 2034) granted Feb 2026 and asserted against four generic ANDA filers (Navinta, Aurobindo, Esjay, Somerset, Sun Pharma).

  MD&A: Commercial; Legal Proceedings verify on EDGAR →