uniQure: FDA Type B meeting para sa AMT-130 itinakda sa Q2 2026

uniQure ay binigyan ng Type B meeting kasama ang FDA upang talakayin ang potensyal na bagong disenyo ng klinikal na pagsubok at plano ng istatistikal na pagsusuri para sa apat na taong datos ng AMT-130. Ang pagpupulong ay sumunod sa Type A meeting kung saan ipinahiwatig ng FDA na ang kasalukuyang datos ng Phase I/II na inihambing sa panlabas na kontrol ay hindi sapat para sa aplikasyon sa marketing.

Mahahalagang fact

Na-file: May 5, 2026, 11:06 AM
Kaganapan: Naiskedyul ang advisory committee
Direksyon: Neutral
Kumpanya: QUREuniQure
Asset: AMT-130
Pinagmulan: SEC 8-K
Kumpiyansa: May source
Kalendaryo: Advisory committee · Abr 1, 2026 · Walang naitalang resulta

Sipi mula sa source

EX-99.1 2 qure-20260505xex99d1.htm EX-99.1 Exhibit 99.1 uniQure Announces First Quarter 2026 Financial Results and Provides Recent Company Updates ~ Advancing FDA interactions on AMT-130 for Huntington’s disease; Type B meeting scheduled for the second quarter of 2026 ~ ~ Progressing AMT-130 toward expected UK regulatory submission; MAA on track for third quarter of 2026 following successful pre-submission meeting with UK MHRA~ ~ Enrollment in AMT-260 temporal lobe epilepsy program on track; clinical update from first cohort in Phase I/IIa study to be presented at the Epilepsy Foundation Pipeline Conference ~ ~ Presented updated data from AMT-191 Phase I/IIa in Fabry disease study showed sustained increases in α-Gal A Enzyme Activity and stable Lyso-Gb3 levels; subsequently all 11 dosed

SEC 8-K