Pipeline Progress Continues with ‘202 Confirmatory Enrollment Completion

研报英文原文证据摘录

Pipeline Progress Continues with ‘202 Confirmatory Enrollment Completion

Update

June 24, 2026 02:24 PM GMT

Morgan Stanley & Co. LLCMRegenxbio Inc | North America Judah C. Frommer, CFA

Equity Analyst

Pipeline Progress Continues Judah.Frommer@morganstanley.comNicholas D Japhet +1 212 761-1270

Research Associate

Nick.Japhet@morganstanley.com +1 212 761-2721

with '202 Confirmatory Parth Patel

Parth.Patel@morganstanley.com +1 212 761-5065

Enrollment Completion

Regenxbio Inc (RGNX.O, RGNX US)

Biotechnology | United States of America

Key Takeaways Stock Rating Overweight

Industry View Attractive

RGNX announced that it has completed enrollment in the confirmatory study of Price target $16.00

RGX-202 for DMD ahead of schedule Shr price, close (Jun 23, 2026) $9.95

Mkt cap, curr (mm) $522

Company is on track to initiate a rolling BLA submission in 3Q26 supporting a 52-Week Range $16.19-5.46

potential 2H27 approval

Update follows recent FDA alignment on MPS II program

RGNX announced that it has completed dosing in its confirmatory study of RGX-

202 ahead of schedule (the company had previously guided to dosing completion

by mid-year), which the company attributes to patient demand and investigator

interest. Plans for a BLA filing under the accelerated approval pathway also remain

on-track, with a rolling submission expected to begin in 3Q26 with completion in

1Q27. Recall, RGNX recently reported topline results from the pivotal portion of

AFFINITY DUCHENNE (see here) that showed a correlation between

microdystrophin expression and functional changes, as well as potentially

differentiated safety.

Completion of the rolling BLA in 1Q27 would support a potential approval by 2H27.

The BLA submission will include efficacy data from the pivotal portion of the study