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RARE ULTRAGENYX PHARMACEUTICAL INC US FDA Inspections 8-K Filing

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ULTRAGENYX PHARMACEUTICAL INC

(RARE)

2025 8-K

FDA Application Update

FDA Approval Announcement

Positive Study Results

FDA Review Announcement

Restructuring Announcement

New Clinical Data

BLA Resubmission Update

Revenue Results Preview

BLA Submission Update

Clinical Trial Results

Royalty Agreement Signed

Patient Dosing Initiated

Positive DTX401 Results

FDA Application Start

Financial Statements

Product Expansion

Pre-Market Approval

Clinical Trials

Pre-Market Approval

Earnings Releases

Financial Results

FDA Application

Financial Results

FDA Designation

UX701 Study Update

Earnings Reports

FDA Meeting for Phase 3 Stu...

Annual Meeting and Election...

Public Offering

FDA Meeting for UX111 Gene ...

Phase 2/3 Orbit Study Results

Positive Phase 3 Results fo...

Financial Results Announcement

New Data from Phase 1/2 Stu...

Earnings Reports

Earnings Reports

Bylaws Amendment

Earnings Reports

Underwriting Agreement for ...

Pipeline Updates

Appointment Change

Financial Results Announcement

Annual Meeting Approval

Phase 2 Orbit study data an...

FDA Protocol Amendment

Earnings Report

Departure of Directors or C...

Financial Results Announcement

Earnings Reports

External Links:

On December 30, 2025, Ultragenyx Pharmaceutical Inc. announced the completion of its Biologics License Application (BLA) submission to the FDA for DTX401 gene therapy aimed at treating Glycogen Storage Disease Type Ia, supported by data from a study involving 52 patients. The treatment has shown significant benefits in reducing daily cornstarch intake while improving patient quality of life.

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