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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

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 July 11, 2025, Ultragenyx Pharmaceutical Inc. announced that the FDA issued a Complete Response Letter for its BLA for UX111 gene therapy, requesting more information related to manufacturing but not raising concerns about clinical data.

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ULTRAGENYX PHARMACEUTICAL INC

2025

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