प्राथमिक स्रोत रिकॉर्ड
निर्णायकअन्य
यूनीक्योर: FDA अब यह नहीं मानता कि फेज़ I/II डेटा AMT-130 की BLA के लिए पर्याप्त है
FDA reversed prior guidance and now states that Phase I/II data versus external control may not be adequate as primary evidence for a BLA submission. The timing of the planned BLA filing for AMT-130 is now unclear. uniQure will seek final meeting minutes and urgent follow-up discussions with the FDA to identify a path forward.
मुख्य तथ्य
- फाइल किया गया
- 3 नव॰ 2025, 12:06 pm
- घटना
- अन्य
- दिशा
- नकारात्मक
- कंपनी
QUREuniQure- संपत्ति
- AMT-130
- स्रोत
- SEC 8-K
- विश्वसनीयता
- स्रोत सहित
स्रोत का अंश
EX-99.1 2 qure-20251103xex99d1.htm EX-99.1 Exhibit 99.1 uniQure Provides Regulatory Update on AMT-130 for Huntington ’ s Disease Lexington, MA and Amsterdam, the Netherlands, November 3, 2025 — uniQure N.V. (NASDAQ: QURE), a leading gene therapy company advancing transformative therapies for patients with severe medical needs, today announced that it received feedback from the U.S. Food and Drug Administration (FDA) during a recent pre-Biologics License Application (BLA) meeting regarding AMT-130, an investigational gene therapy for Huntington ’ s disease (HD). Though final meeting minutes have not yet been received, based on the discussions at the meeting, uniQure believes that the FDA currently no longer agrees that data from the Phase I/II studies of AMT-130 in comparison to an ex
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