uniQure N.V. 8-K
Accession 0001104659-26-002317
Filed
Jan 8, 7:00 PM ET
Accepted
Jan 9, 7:06 AM ET
Size
169.5 KB
Accession
0001104659-26-002317
Research Summary
AI-generated summary of this filing
uniQure N.V. Schedules Type A Meeting with FDA
What Happened
uniQure N.V. announced on January 9, 2026 (via an 8-K filing, Item 7.01) that a Type A meeting with the U.S. Food and Drug Administration has been scheduled. The company furnished a press release about the meeting as Exhibit 99.1 to the Form 8-K.
Key Details
- Filed Form 8-K dated January 9, 2026 under Item 7.01 (Regulation FD Disclosure).
- Announcement: a Type A meeting with the U.S. FDA has been scheduled (press release furnished as Exhibit 99.1).
- The 8-K was signed by Jeannette Potts, Chief Legal and Compliance Officer.
- No financial results, executive changes, or additional regulatory outcomes were reported in this filing.
Why It Matters
Regulatory meetings with the FDA are formal steps in the drug development and review process. Investors should note that scheduling a Type A meeting indicates active engagement with the FDA on a specific regulatory issue; the meeting’s outcome could affect development timelines, regulatory strategy, or future disclosures. This 8-K does not include details on the meeting’s agenda or expected timing for outcomes, so watch for subsequent updates or follow-up filings.
Documents
- 8-Kqure-20260109x8k.htmPrimary
8-K
- EX-99.1qure-20260109xex99d1.htm
EX-99.1
- GRAPHICqure-20260109xex99d1001.jpg
GRAPHIC
- EX-101.SCHqure-20260109.xsd
EX-101.SCH
- EX-101.LABqure-20260109_lab.xml
EX-101.LAB
- EX-101.PREqure-20260109_pre.xml
EX-101.PRE
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Issuer
uniQure N.V.
CIK 0001590560
Related Parties
1- filerCIK 0001590560
Filing Metadata
- Form type
- 8-K
- Filed
- Jan 8, 7:00 PM ET
- Accepted
- Jan 9, 7:06 AM ET
- Size
- 169.5 KB