uniQure: nasa tamang takbo ang BLA filing ng AMT-130 para sa Q3 2026; 4-taong datos sa Setyembre

Matapos ang Type B FDA meeting, nakumpirma ng uniQure ang pagkakahanay na ang accelerated-approval BLA para sa AMT-130 sa sakit na Huntington’s ay maaaring isumite batay sa kasalukuyang datos. Nananatili ang kumpanya sa iskedyul na maghain ng BLA sa Q3 2026 at ipapakita ang apat na taong follow-up data ng Phase I/II sa Setyembre 2026.

Mahahalagang fact

Na-file: Hul 29, 2026, 11:06 AM
Kaganapan: Naisumite ang aplikasyon
Direksyon: Positibo
Kumpanya: QUREuniQure
Asset: AMT-130
Pinagmulan: SEC 8-K
Kumpiyansa: May source

Sipi mula sa source

EX-99.1 2 qure-20260729xex99d1.htm EX-99.1 Exhibit 99.1 uniQure Announces Second Quarter 2026 Financial Results and Provides Company Update ~ U.S. and U.K. regulatory submissions for AMT-130 for Huntington’s disease on track as planned for the third quarter of 2026 ~ ~ Topline four-year data from the Phase I/II study of AMT-130 expected in September 2026 ~ ~ Reported data from the first cohort in the Phase I/IIa trial of AMT-260 for refractory mesial temporal lobe epilepsy showed early biological signals of therapeutic activity and a favorable safety profile ~ ~ Strengthened financial position with $259 million follow-on offering, extending cash runway into 2030 and funding the anticipated commercial launch of AMT-130 and continued pipeline investment ~ ~ uniQure to host earnings call at

SEC 8-K