Regenxbio

RGNX

Market cap $511M

One-time gene therapy treatment with sura-vec demonstrated long-term efficacy at similar doses to those being evaluated in ongoing late-stage studies: Stable to improved vision through 5 years in wet AMD patients who required frequent anti-VEGF injections prior to one-time sura-vec; no drug-related IOI observed in a setting of no prophylactic steroids Prevention of vision-threatening events without any additional treatment and > 2-step DRSS improvement in majority of NPDR participants at 2.5 years; no IOI observed with short-course prophylactic topical steroids Topline data from wet AMD pivotal studies, ATMOSPHERE® and ASCENT®, expected in Q4 2026 ROCKVILLE, Md.,, July 18, 2026 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced positive data from long-term follow-up studies of investigational surabgene lomparvovec (sura-vec, ABBV-RGX-314) in wet AMD using subretinal delivery and diabetic retinopathy (DR) using suprachoroidal delivery.

ROCKVILLE, Md., July 17, 2026 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced the pricing of an underwritten public offering of 10,003,889 shares of its common stock at the price of $9.00 per share and 1,111,111 pre-funded warrants at a price of $8.9999 per warrant, in each case before underwriting discounts and commissions.

ROCKVILLE, Md., July 16, 2026 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced that it intends to offer and sell, subject to market conditions, $100 million of its common stock in an underwritten public offering.

NEW YORK, July 13, 2026 (GLOBE NEWSWIRE) -- Kuehn Law, PLLC, a shareholder litigation law firm, is investigating whether certain officers and directors of  Regenxbio, Inc. (NASDAQ: RGNX) breached their fiduciary duties to shareholders.

New long-term data from diabetic retinopathy and wet AMD programs to be presented at American Society of Retina Specialists (ASRS) 2026 ROCKVILLE, Md., June 29, 2026 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced the first patient has been dosed in the Phase IIb/III NAAVIGATE clinical trial of investigational surabgene lomparvovec (sura-vec, ABBV-RGX-314) in diabetic retinopathy (DR) using suprachoroidal delivery.

REGENXBIO upgraded to 'Strong Buy' on FDA's course reversal for rare disease therapies, notably impacting NAVSUNLI [RGX-121] for MPS II. Company expects to resubmit NAVSUNLI BLA in Q3 2026, leveraging robust CAMPSIITE trial data and no new study requirements per FDA alignment. RGX-202 for DMD and sura-vec for wet AMD offer additional catalysts, with pivotal trial data and regulatory submissions anticipated through 2027.

Confirmatory study completed ahead of schedule due to strong patient demand and robust investigator interest On track to initiate BLA in Q3 2026 under the accelerated approval pathway supporting potential approval in 2H 2027 ROCKVILLE, Md., June 24, 2026 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced the successful completion of dosing in the confirmatory study of RGX-202, a potential best-in-class gene therapy for Duchenne muscular dystrophy.

RGNX shares jump after FDA alignment on next steps for Navsunli, paving the way for a planned MPS II BLA resubmission in Q3 2026.

Regenxbio Inc. (NASDAQ:RGNX) on Monday said it aligned with the Food and Drug Administration (FDA) regarding the next steps needed for a potential accelerated approval of Navsunli (RGX-121, clemidsogene lanparvovec).

Regenxbio is a gene therapy biotech built around RGX-202 for Duchenne and ABBV-RGX-314 for retinal disease. They also have RGX-121, though its prospects are slightly more uncertain. Fortunately, RGX-202's Phase 3 data keep RGNX promising. But this is a longer-term bet, and my best-case scenario won't play out at least until 2028.