REGENXBIO: RGX-121 PDUFA itinakda sa Pebrero 8, 2026

Itinalaga ng FDA ang PDUFA target action date na Pebrero 8, 2026 para sa RGX-121 BLA. Inaasahan ng kumpanya na ang pag-apruba ay magbibigay ng Priority Review Voucher na ganap na pagmamay-ari nila.

Mahahalagang fact

Na-file: Nob 6, 2025, 12:38 PM
Kaganapan: Naitakda ang petsa ng PDUFA
Direksyon: Neutral
Kumpanya: RGNXREGENXBIO
Asset: clemidsogene lanparvovec
Pinagmulan: SEC 8-K
Kumpiyansa: May source
Kalendaryo: Desisyon ng FDA (PDUFA) · Peb 8, 2026 · Complete response letter

Sipi mula sa source

EX-99.1 2 rgnx-ex99_1.htm EX-99.1 EX-99.1 EXHIBIT 99.1 REGENXBIO Reports Third Quarter 2025 Financial Results and Operational Highlights • RGX-202 program for Duchenne muscular dystrophy advancing rapidly, topline results expected early Q2 2026 and BLA submission mid-2026 o Pivotal trial enrollment completed in October; confirmatory trial open and enrolling o New 12-month analysis shows all participants demonstrate improved functional outcomes across multiple natural history methods of measurement, when decline is expected • Clemidsogene lanparvovec (RGX-121) on track to be first gene therapy and one-time treatment for MPS II; PDUFA date February 8, 2026 • Surabgene lomparvovec (sura-vec, ABBV-RGX-314) on track to be first gene therapy for chronic retinal disease o Enrollment comp

SEC 8-K