Welcome to our dedicated page for Regenxbio news (Ticker: RGNX), a resource for investors and traders seeking the latest updates and insights on Regenxbio stock.
REGENXBIO Inc. reports news on its AAV gene therapy pipeline and manufacturing platform for rare, neuromuscular and retinal diseases. Recurring updates cover RGX-202 for Duchenne muscular dystrophy; clemidsogene lanparvovec (RGX-121) for MPS II; RGX-111 for MPS I; and surabgene lomparvovec (ABBV-RGX-314) for wet AMD and diabetic retinopathy.
Company announcements also include FDA regulatory communications, clinical and preclinical data presentations, financial results, operational highlights, and collaboration activity with partners including Nippon Shinyaku and AbbVie. News on the NAV and NAVXpress platforms addresses AAV vector technology, product quality, and manufacturing capabilities used across REGENXBIO's investigational programs.
REGENXBIO (Nasdaq: RGNX) appointed Greg Ciongoli to its Board of Directors, effective August 25, 2026, as the company prepares for a transition to a global commercial organization supported by multiple upcoming catalysts in its late-stage gene therapy pipeline.
Concurrent with his appointment, long-serving independent directors Jerry Karabelas, Ph.D. (on the Board since 2015) and Jean Bennett, M.D., Ph.D. (since 2021) are retiring from the Board. According to REGENXBIO, Ciongoli brings extensive experience in biotechnology investing, capital allocation, corporate strategy and healthcare-focused governance. He is Founder and Managing Partner of Adiumentum Capital Management and previously spent over 16 years at The Baupost Group, leading investments across public and private markets. Ciongoli currently chairs the Board of Atara Biotherapeutics and sits on the Board of Zymeworks, complementing REGENXBIO’s focus on advancing late-stage AAV gene therapies for Duchenne, retinal diseases, MPS I and MPS II.
REGENXBIO (Nasdaq: RGNX) reported that the U.S. FDA has placed a clinical hold on its investigational MPS II gene therapy RGX-121 (clemidsogene lanparvovec), following discovery of asymptomatic spine MRI findings in five participants in the CAMPSIITE study. The company does not expect to resubmit the RGX-121 BLA in the near term.
The five participants, dosed intracisternally or intraventricularly about three to six years ago, remain clinically well with stable to improved neurocognitive and neurobehavioral assessments. Investigators deemed the small spinal nodules or cystic masses nonserious, and radiologists believe they are likely benign. No brain nodules or masses were observed.
REGENXBIO and partner NS Pharma are evaluating additional imaging and long-term follow-up data and will incorporate FDA feedback into next steps. The company highlighted continued focus on its Duchenne and retinal disease candidates, including a planned Duchenne BLA submission this quarter and wet AMD pivotal topline data in the fourth quarter.
REGENXBIO (Nasdaq: RGNX) reported Q2 2026 revenues of $108.0 million, up sharply from $21.4 million a year earlier, driven mainly by a $100 million AbbVie milestone tied to first dosing in the Phase IIb/III NAAVIGATE diabetic retinopathy study. Net income was $22.7 million, or $0.43 per share, versus a $70.9 million loss in Q2 2025.
Cash, cash equivalents and marketable securities were $105.5 million on June 30, 2026; including July’s $100 million milestone and roughly $108 million in equity offering proceeds, pro forma cash exceeded $313 million, extending the cash runway into Q4 2027. Operationally, the Phase III AFFINITY DUCHENNE trial for RGX-202 met its primary endpoint with high statistical significance, RGX-202’s confirmatory study fully enrolled ahead of schedule, and the FDA confirmed no additional studies are needed for RGX-121’s planned Q3 2026 BLA resubmission. Topline data for surabgene lomparvovec (ABBV-RGX-314) wet AMD pivotal trials are expected in Q4 2026, with multiple BLA submissions targeted between 2026 and 2027.
REGENXBIO (Nasdaq: RGNX) will host a conference call on Thursday, August 6, at 8:00 a.m. ET to discuss financial results for the quarter ended June 30, 2026, and operational highlights. Webcast registration links are provided for listeners and analysts, with a replay available on the investor website about two hours after the call.
REGENXBIO (Nasdaq: RGNX) reported positive long-term data for investigational gene therapy surabgene lomparvovec (sura-vec, ABBV-RGX-314) in wet age-related macular degeneration (wet AMD) and diabetic retinopathy (DR) at the ASRS 2026 meeting.
In wet AMD, Phase I/IIa Cohorts 3 and 4 receiving subretinal sura-vec at doses similar to those in ongoing ATMOSPHERE and ASCENT pivotal trials showed stable to improved visual acuity and meaningful reductions in anti-VEGF injection burden through five years, with no new safety signals and no intraocular inflammation in completers. An external control study indicated preserved vision, less retinal thickness fluctuation and significantly fewer injections versus real-world anti-VEGF therapy at one year.
In DR, 2.5-year follow-up from the ALTITUDE trial using suprachoroidal delivery at Dose Level 3 showed 55% of NPDR participants achieving >2-step DRSS improvement without additional treatment and 70% experiencing no vision-threatening events, with no intraocular inflammation in 17 participants. Topline wet AMD pivotal data with AbbVie from ATMOSPHERE and ASCENT are expected in Q4 2026.
REGENXBIO (Nasdaq: RGNX) priced an underwritten public offering of 10,003,889 common shares at $9.00 per share and 1,111,111 pre-funded warrants at $8.9999 per warrant, before underwriting discounts and commissions. Expected gross proceeds are approximately $100 million, excluding the underwriters’ option.
The offering is expected to close on July 20, 2026, subject to customary conditions. REGENXBIO granted underwriters a 30-day option to buy up to an additional 1,667,250 common shares. Morgan Stanley, J.P. Morgan, Leerink Partners and Mizuho are joint book-running managers.
REGENXBIO (Nasdaq: RGNX) announced that it intends to conduct an underwritten public offering of $100 million of its common stock, subject to market and other conditions. The company noted there is no assurance regarding completion, timing, actual size or final terms of the offering.
According to REGENXBIO, the company also plans to grant underwriters a 30-day option to purchase up to 15% additional common shares. Morgan Stanley, J.P. Morgan, Leerink Partners and Mizuho are acting as joint book-running managers. The offering will be made under an effective Form S-3 shelf registration statement filed in November 2025.
REGENXBIO (Nasdaq: RGNX) dosed the first patient in the Phase IIb/III NAAVIGATE trial of investigational surabgene lomparvovec in diabetic retinopathy using suprachoroidal delivery, triggering a $100 million milestone payment from AbbVie.
NAAVIGATE will evaluate a 1.0x1012 GC/eye dose in non-proliferative DR, with a primary endpoint of >2-step DRSS improvement at one year. The Phase IIb portion plans to enroll about 135 U.S. participants. REGENXBIO also plans to present long-term ALTITUDE and wet AMD data at ASRS 2026 and expects pivotal ATMOSPHERE and ASCENT topline data in Q4 2026.
REGENXBIO (Nasdaq: RGNX) completed dosing in the confirmatory study of RGX-202 for Duchenne muscular dystrophy, marking completion of the registrational development program.
This supports initiating a BLA in Q3 2026 under the accelerated approval pathway, targeting potential FDA approval in 2H 2027, backed by safety data from 63 patients and pivotal efficacy data from 30 patients.
REGENXBIO (Nasdaq:RGNX) announced agreement with the FDA on the path to resubmit its BLA for NAVSUNLI™, a potential one-time gene therapy for MPS II (Hunter syndrome). No additional studies or new patients are required, and the FDA plans an expedited review.
A Type A meeting is expected in July, with BLA resubmission targeted for Q3 2026.