Catatan sumber primer
PenentuHasil topline
REGENXBIO: Data topline pivotal RGX-202 diharapkan awal Q2 2026
Perusahaan mengumumkan bahwa hasil topline pivotal dari uji coba konfirmatori Phase I/II AFFINITY DUCHENNE untuk RGX-202 diharapkan pada awal Q2 2026. Pendaftaran dalam uji coba konfirmatori (n=30) sedang berlangsung dan mayoritas pasien diharapkan telah terdaftar pada saat pengajuan BLA yang direncanakan.
Fakta utama
- Diajukan
- 5 Mar 2026, 12.30
- Peristiwa
- Hasil topline
- Arah
- Netral
- Perusahaan
RGNXREGENXBIO- Aset
- RGX-202
- Sumber
- SEC 8-K
- Keyakinan
- Bersumber
Kutipan sumber
EX-99.1 2 rgnx-ex99_1.htm EX-99.1 EX-99.1 EXHIBIT 99.1 REGENXBIO Reports Fourth Quarter and Full Year 2025 Financial Results and Operational Highlights • Late-stage gene therapy pipeline for rare and retinal diseases advancing toward key catalysts o RGX-202 for Duchenne muscular dystrophy: New Phase I/II data at MDA, topline pivotal results expected early Q2 2026 - Robust patient enrollment continues in confirmatory trial o Surabgene lomparvovec (sura-vec, ABBV-RGX-314) subretinal wet AMD topline pivotal data expected in Q4 2026; first patient dosed in pivotal Phase IIb/III trial in diabetic retinopathy expected in Q2 2026 • Company to engage FDA on potential path forward for RGX-121 • Conference call today at 8:00 a.m. ET ROCKVILLE, Md., March 5, 2026 (PR Newswire) -- REGENXBIO