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Apr 04, 2026
Ultragenyx began a restructuring plan that includes a 10% workforce reduction and termination of UX143 manufacturing agreements. The company also faces a class action tied to setrusumab disclosures.
Mar 28, 2026
Class action lawsuits allege false statements about clinical trial results and regulatory prospects at Atara Biotherapeutics, Ultragenyx, Mereo BioPharma, and Vistagen Therapeutics. The complaints cite failed Phase 3 studies for setrusumab in Osteogenesis Imperfecta and fasedienol for social anxiety disorder, along with manufacturing issues affecting Atara's tabelecleucel application. Investors have deadlines ranging from April to May 2026 to seek lead plaintiff status.
Mar 10, 2026
Opus Genetics reported positive early data from its BEST1 gene therapy program and expects FDA action on its presbyopia treatment in October 2026. Ultragenyx announced 2025 revenue of $673 million and initiated a strategic restructuring plan targeting profitability in 2027.
Feb 23, 2026
The FDA has accepted Ultragenyx's BLA for DTX401, an AAV gene therapy for Glycogen Storage Disease Type Ia, granting Priority Review with a PDUFA action date of August 23, 2026.
Feb 17, 2026
Ultragenyx Pharmaceutical confronts multiple shareholder class action lawsuits over Phase III trial disclosures while reporting positive UX111 gene therapy data and implementing a 10% workforce reduction.
Feb 16, 2026
The global antibodies market is projected to reach $667.8 billion by 2032 with a 12.9% CAGR, while high throughput antibody production services are expected to grow at 11.2% CAGR through 2033, driven by biopharmaceutical development and monoclonal antibody therapeutics demand.
Feb 14, 2026
Ultragenyx Pharmaceutical announced positive long-term clinical data for UX111 gene therapy for Sanfilippo syndrome Type A, with up to 8.5 years of follow-up showing sustained biomarker reductions and functional improvements. The company resubmitted its BLA to the FDA in January 2026.
Feb 14, 2026
Ultragenyx Pharmaceutical received an Incomplete Response Letter from the FDA for its UX111 gene therapy resubmission for Sanfilippo syndrome type A, requesting additional documentation. The company announced a 10% workforce reduction and expects profitability by 2027.
Feb 13, 2026
Ultragenyx will lay off 130 employees as part of restructuring aimed at profitability by 2027. The FDA rejected the company's gene therapy application for Sanfilippo syndrome due to manufacturing concerns.
Feb 13, 2026
Ultragenyx reported Q4 2025 revenues of $207 million, up 25% year-over-year, while announcing a 10% workforce reduction and resubmission of its UX111 gene therapy application following positive long-term clinical data.
Dec 30, 2025
Ultragenyx Pharmaceutical faces federal securities class action lawsuits following the failure of Phase 3 Orbit and Cosmic studies for setrusumab in Osteogenesis Imperfecta, with stock falling over 42% after December 2025 results announcement.
