Ultragenyx Pharmaceutical INC 8-K filings

Ultragenyx Pharmaceutical Inc. has reached a settlement agreement resolving patent litigation concerning its DOJOLVI oral liquid with Esjay Pharma.

Ultragenyx Pharmaceutical Inc. held its Annual Meeting on May 14, 2026, where stockholders approved the Third Amended and Restated 2023 Incentive Plan and ratified the appointment of Ernst & Young LLP.

Ultragenyx Pharmaceutical Inc. announced first quarter 2026 financial results, reporting $136 million in total revenue and reaffirming its full-year 2026 revenue guidance of $730 million to $760 million, while providing updates on key clinical programs.

The FDA has accepted the resubmitted Biologics License Application for UX111, setting a PDUFA action date of September 19, 2026.

Ultragenyx received FDA IND clearance for UX016, a sialic acid prodrug, and plans a patient-funded Phase 1/2 GNEM study in the second half of 2026.

Ultragenyx Pharmaceutical Inc. announced positive Phase 3 Enh3ance study results for its DTX301 gene therapy, demonstrating significant ammonia reduction in OTC deficiency patients.

The FDA has accepted Ultragenyx's Biologics License Application for DTX401 gene therapy for GSDIa, granting it Priority Review with an August 23, 2026 action date.

Ultragenyx Pharmaceutical Inc. announced its full year 2025 financial results, reported 20% revenue growth, and initiated a strategic restructuring plan including a 10% workforce reduction, while reiterating a path to profitability by 2027.

Ultragenyx Pharmaceutical Inc. announced positive long-term clinical data for its investigational gene therapy UX111, demonstrating significant functional and biomarker improvements in Sanfilippo syndrome type A patients.

Ultragenyx Pharmaceutical Inc. has resubmitted its Biologics License Application for UX111, an AAV9 gene therapy for Sanfilippo syndrome type A, to the FDA.

Ultragenyx Pharmaceutical Inc. reported preliminary unaudited 2025 total revenue exceeding guidance and outlined significant clinical and regulatory milestones for 2026.

Ultragenyx Pharmaceutical Inc. has completed its Biologics License Application submission to the FDA for DTX401 AAV gene therapy for Glycogen Storage Disease Type Ia.

Ultragenyx Pharmaceutical Inc. announced that its Phase 3 Orbit and Cosmic studies for setrusumab in Osteogenesis Imperfecta did not meet primary endpoints for fracture rate reduction, despite showing improvements in bone mineral density.

Ultragenyx bolstered its balance sheet with a $400 million royalty sale for Crysvita and reported third-quarter 2025 financial results, reaffirming full-year guidance.

Ultragenyx Pharmaceutical Inc. announced the dosing of the first patient in its global Aurora study evaluating GTX-102 for Angelman syndrome, expanding the patient population beyond its ongoing Phase 3 Aspire study.

Ultragenyx Pharmaceutical Inc. announced positive longer-term Phase 3 results for its DTX401 gene therapy, demonstrating sustained and improved efficacy in treating glycogen storage disease type Ia.

Ultragenyx Pharmaceutical Inc. has initiated a rolling Biologics License Application submission to the FDA for DTX401, its AAV gene therapy for Glycogen Storage Disease Type Ia.

Ultragenyx reports strong second quarter 2025 financial results with 13% revenue growth, reaffirms full-year guidance, and provides key clinical program updates including a Breakthrough Therapy Designation for GTX-102.

Ultragenyx Pharmaceutical Inc. announced the full enrollment of its Phase 3 Aspire study for GTX-102, a treatment for Angelman Syndrome, marking a significant step towards potential regulatory submission.

Ultragenyx Pharmaceutical Inc. announced that the U.S. Food and Drug Administration issued a Complete Response Letter for its Biologics License Application for UX111, citing chemistry, manufacturing, and controls issues and facility inspection observations.

Ultragenyx Pharmaceutical Inc. announced that its Phase 3 Orbit study for UX143 (setrusumab) in osteogenesis imperfecta is progressing as planned towards final analysis by year-end, with the Data Monitoring Committee confirming an acceptable safety profile.

Ultragenyx Pharmaceutical Inc. announced it has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for GTX-102 (apazunersen) as a treatment for Angelman syndrome, based on positive Phase 1/2 clinical data.

Ultragenyx Pharmaceutical Inc. stockholders approved the Second Amended and Restated 2023 Incentive Plan at the Annual Meeting held on May 15, 2025.

Ultragenyx announced a 28% increase in total revenue for Q1 2025, driven by strong Crysvita and Dojolvi sales, and reaffirmed its 2025 financial guidance.

Ultragenyx announces positive financial results for 2024, exceeding revenue guidance, and sets ambitious revenue targets for 2025, driven by key products and pipeline advancements.

Ultragenyx reported preliminary 2024 revenue exceeding expectations, provided 2025 financial guidance, and updated on key clinical program milestones.

Ultragenyx has dosed the first patient in its Phase 3 Aspire study evaluating GTX-102 for Angelman syndrome.

Ultragenyx has submitted a Biologics License Application to the FDA for its UX111 gene therapy, targeting Sanfilippo syndrome type A, based on positive clinical data.

Ultragenyx reported positive Phase 1/2 data for GTX-102, an investigational treatment for Angelman syndrome, demonstrating significant improvements in cognition and other key areas, supporting the ongoing Phase 3 trial.

Ultragenyx announced a 42% year-over-year revenue increase in the third quarter of 2024, driven by strong sales of Crysvita and Dojolvi, and provided updates on its clinical programs.