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RGNX biotech catalysts & pipeline

REGENXBIO INC · Data as of 2026-09-08

Upcoming catalysts

ABBV-RGX-314 — Topline data

in 2026

Topline data from these trials are expected to be shared in 2026.
Source filing

clemidsogene lanparvovec — NDA/BLA submission

Q3 2026

REGENXBIO plans to resubmit the BLA in Q3 2026.
Source filing

RGX-202 — NDA/BLA submission

this quarter

We remain focused on our Duchenne and retinal disease candidates, which utilize a different capsid and routes of administration, with near-term catalysts that are on track, including the planned submission of the Duchenne BLA this quarter and the wet AMD topline pivotal data announcement in the fourth quarter.
Source filing

surabgene lomparvovec — Topline data

Q4 2026

We remain focused on our Duchenne and retinal disease candidates, which utilize a different capsid and routes of administration, with near-term catalysts that are on track, including the planned submission of the Duchenne BLA this quarter and the wet AMD topline pivotal data announcement in the fourth quarter.
Source filing

surabgene lomparvovec — NDA/BLA submission

2027

Global regulatory submissions are expected in 2027.
Source filing

RGX-202 — Regulatory decision

2H 2027

The Company is on track to initiate a BLA submission in Q3 2026 under the accelerated approval pathway, supporting potential approval in 2H 2027.
Source filing

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