1차 출처 기록
결정급탑라인 결과
REGENXBIO: RGX-202 피봇 톱라인 데이터, 2026년 2분기 초 예상
The company announced that pivotal topline results from the confirmatory Phase I/II AFFINITY DUCHENNE trial of RGX-202 are expected in early Q2 2026. Enrollment in the confirmatory trial (n=30) is ongoing and the majority of patients are expected to be enrolled by the time of the planned BLA submission.
핵심 사실
출처 발췌
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