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Positive biomarker data in patient aged 1-3 add to consistent, robust microdystrophin and transduction levels across all treated ages Patient aged 3 years at dosing had expression level at 122.3% compared to control With a differentiated novel construct and proactive short course immune modulation regimen, RGX-202 continues to demonstrate encouraging safety profile with no SAEs or AESIs Phase III portion of AFFINITY DUCHENNE® trial enrolling ambulatory patients aged 1 and above, on track for BLA submis ...

REGENXBIO Inc. (NASDAQ:RGNX) Q4 2024 Earnings Conference Call March 13, 2025 4:30 PM ET Company Participants Patrick Christmas - Chief Legal Officer Curran Simpson - President & Chief Executive Officer Steve Pakola - Chief Medical Officer Mitch Chan - Chief Financial Officer Conference Call Participants Judah Frommer - Morgan Stanley Gena Wang - Barclays Annabel Samimy - Stifel Brian Skorney - Baird Paul Choi - Goldman Sachs Ellie Merle - UBS Sean McCutcheon - Raymond James Alec Stranahan - Bank of America ...

Regenxbio (RGNX) came out with a quarterly loss of $1.01 per share versus the Zacks Consensus Estimate of a loss of $1.27. This compares to loss of $1.43 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of 20.47%. A quarter ago, it was expected that this biotechnology company would post a loss of $1.16 per share when it actually produced a loss of $1.17, delivering a surprise of -0.86%.Over the last four quarters, the company has ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2024 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 001-37553 REGENXBIO Inc. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organiz ...

EXHIBIT 99.1 REGENXBIO Reports Fourth Quarter and Full Year 2024 Financial Results and Recent Operational Updates ROCKVILLE, Md., March 13, 2025 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today reported financial results and recent operational highlights for the fourth quarter and year ended December 31, 2024. "REGENXBIO is on the cusp of delivering potential first- or best-in-class gene therapies to market. In 2025, we have already submitted our first BLA and will accelerate late-stage development and a ...

Biologics Licensing Application (BLA) for clemidsogene lanparvovec (RGX-121) submitted and on track for potential FDA approval 2H 2025; strategic partnership with Nippon Shinyaku aims to expand potential access and commercial opportunity in MPS II and MPS I Pivotal trial of RGX-202 for Duchenne Muscular Dystrophy progressing rapidly; enrollment completion expected in 2025 with BLA filing in mid-2026 AbbVie-partnered retinal franchise continues advancing; pivotal data evaluating the safety and efficacy of ...

ROCKVILLE, Md., March 10, 2025 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced new interim biomarker data from the Phase I/II portion of the AFFINITY DUCHENNE® trial of RGX-202 for the treatment of Duchenne muscular dystrophy will be presented at the 2025 Muscular Dystrophy Association (MDA) Clinical & Scientific Conference, taking place in Dallas, TX, March 16-19, 2025. Title: RGX-202, an investigational gene therapy for the treatment of Duchenne Muscular Dystrophy: Interim clinical data (O75 ...

The market expects Regenxbio (RGNX) to deliver a year-over-year increase in earnings on higher revenues when it reports results for the quarter ended December 2024. This widely-known consensus outlook is important in assessing the company's earnings picture, but a powerful factor that might influence its near-term stock price is how the actual results compare to these estimates.The stock might move higher if these key numbers top expectations in the upcoming earnings report, which is expected to be released ...

ROCKVILLE, Md., March 4, 2025 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced the closing of its previously announced strategic partnership with Nippon Shinyaku. Under the terms of the agreement, REGENXBIO and Nippon Shinyaku will develop and commercialize RGX-121 (clemidsogene lanparvovec) for Mucopolysaccharidosis II (MPS II), also known as Hunter syndrome and RGX-111 for Mucopolysaccharidosis I (MPS I), also known as Hurler syndrome in the United States and Asia. "RGX-121 and RGX-111 repres ...