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. (Nasdaq: RGNX) generates frequent news as it advances a late-stage pipeline of adeno-associated virus (AAV) gene therapies for rare and retinal diseases. Company updates often focus on clinical trial progress for RGX-202 in Duchenne muscular dystrophy, clemidsogene lanparvovec (RGX-121) for MPS II, RGX-111 for MPS I, and surabgene lomparvovec (ABBV-RGX-314, sura-vec) for wet age-related macular degeneration and diabetic retinopathy.
News releases highlight functional and biomarker data from ongoing studies, such as long-term North Star Ambulatory Assessment results in the AFFINITY DUCHENNE® trial of RGX-202 and analyses of cerebrospinal fluid biomarkers in MPS II. REGENXBIO also reports on pivotal trial enrollment milestones, including completion of enrollment in the ATMOSPHERE® and ASCENT® pivotal trials for subretinal sura-vec in wet AMD and progress in the ALTITUDE® trial for diabetic retinopathy using suprachoroidal delivery.
Investors following RGNX news can also expect regular disclosures on regulatory interactions and key dates, such as the FDA’s extension of the Prescription Drug User Fee Act (PDUFA) action date for the RGX-121 Biologics License Application and anticipated timelines for pivotal data readouts and BLA submissions. The company’s collaboration and license activities with partners like AbbVie and Nippon Shinyaku, including amendments to development and milestone structures, are typically announced through press releases and corresponding Form 8-K filings.
In addition, REGENXBIO issues announcements about participation in major healthcare and investor conferences, where management presents clinical updates and strategic priorities. For a fuller picture of RGNX stock, readers can use this news feed to track clinical data presentations, manufacturing and commercial readiness updates, financial results press releases and other material events described in the company’s communications.
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REGENXBIO (Nasdaq: RGNX) reported positive interim Phase I/II AFFINITY DUCHENNE data for RGX-202 (data cut Jan 5, 2026). Pivotal-dose participants (2x10^14 GC/kg, n=7) showed improved function vs external controls (NSAA +4.9 vs cTAP at 1 year; older 8+ = +5.2), stable cardiac MRI measures, consistent microdystrophin expression, and no SAEs or AESIs. Liver markers remained below concerning thresholds and new biomarker data showed 51.2% expression in one patient at Week 12. Topline pivotal data expected Q2 2026 with a planned pre-BLA meeting mid-2026.
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REGENXBIO (Nasdaq: RGNX) reported Q4 and full-year 2025 results and operational highlights on March 5, 2026. Key clinical milestones include expected pivotal topline data for RGX-202 in early Q2 2026 and sura-vec wet AMD pivotal data in Q4 2026. Cash, cash equivalents and marketable securities were $240.9M at year-end, with runway into early 2027. 2025 revenues rose to $170.4M, R&D expenses increased to $228.3M, and net loss narrowed to $193.9M for the year. The FDA issued clinical holds on RGX-111 and RGX-121 and a CRL for RGX-121; the company plans to address regulator concerns.
REGENXBIO (Nasdaq: RGNX) announced presentations on its investigational Duchenne gene therapy RGX-202 at the 2026 Muscular Dystrophy Association Clinical & Scientific Conference in Orlando, March 8-11, 2026.
Events include an interim Phase I/II podium presentation on March 11, a preclinical poster, and a company-hosted symposium on March 9 at 12 p.m. ET. Presentation materials will be posted in the company's Publications section.
REGENXBIO (Nasdaq: RGNX) will participate in three investor conferences in March 2026 with multiple fireside chats and webcasts available.
Events include Leerink Partners Global Healthcare on March 9, 2026 at 9:20 AM ET and Barclays Global Healthcare on March 10, 2026 at 1:30 PM ET in Miami, and RBC Virtual Ophthalmology on March 24, 2026 at 8:45 AM ET. Live webcasts and ~30-day archived replays will be available on the company investor website.
REGENXBIO (Nasdaq: RGNX) will host a conference call on Thursday, March 5, 2026 at 8:00 a.m. ET to discuss fourth-quarter and full-year results for the period ended December 31, 2025, and operational highlights.
Investors can register for the webcast, analysts can request Q&A access, and a replay will be posted about two hours after the call.
REGENXBIO (Nasdaq: RGNX) announced the FDA issued a Complete Response Letter (CRL) on February 7, 2026 for its BLA for RGX-121 (clemidsogene lanparvovec) for Mucopolysaccharidosis II (MPS II). The CRL cited concerns about defining the neuronopathic population, comparability of the external natural-history control, and the CSF HS D2S6 surrogate endpoint.
REGENXBIO said the FDA agreed to the study protocol in principle, the company will request a Type A meeting, pursue paths outlined in the CRL, and aims to resubmit the BLA after providing additional analyses and longer-term clinical data.