Rockville, Maryland-based REGENXBIO Inc. (Nasdaq: RGNX) announced a proposed underwritten public offering of common stock, intending to raise USD 100 million in gross proceeds. The REGENXBIO public offering arrives as the gene therapy company advances multiple late-stage programs toward potential regulatory decisions, at a time when several AAV-focused developers have turned to the equity markets this year to shore up balance sheets ahead of anticipated approvals and pivotal readouts.
The REGENXBIO stock offering is being marketed by Morgan Stanley, J.P. Morgan, Leerink Partners and Mizuho as joint book-running managers, with REGENXBIO granting underwriters a 30-day option to purchase up to an additional 15% of shares sold. The final size and pricing of the REGENXBIO common stock sale remain subject to market conditions. The company did not specify a use-of-proceeds breakdown in its announcement, though the raise comes as REGENXBIO continues to fund clinical, manufacturing and regulatory activities across its rare disease and retinal disease portfolio.
REGENXBIO's most advanced program, RGX-202 for Duchenne muscular dystrophy, reported positive pivotal data in May 2026, with 93% of participants achieving at least 10% microdystrophin expression at Week 12. The company is reportedly targeting a Biologics License Application submission later this year under the accelerated approval pathway.
A second asset, clemidsogene lanparvovec (RGX-121, NAVSUNLI), targeting Hunter syndrome (MPS II), has a BLA under FDA review, with REGENXBIO's regulatory timeline extended and a resubmission targeted for the third quarter of 2026; commercialization would be led by partner Nippon Shinyaku. REGENXBIO also co-develops surabgene lomparvovec (ABBV-RGX-314) with AbbVie for wet age-related macular degeneration and diabetic retinopathy, with pivotal wet AMD data expected in the fourth quarter of 2026 and a diabetic retinopathy pivotal trial recently dosing its first patient, triggering a $100 million milestone payment from AbbVie.