REGENXBIONASDAQ: RGNX

Regenxbio (RGNX) saw its shares surge in the last session with trading volume being higher than average. The latest trend in earnings estimate revisions may not translate into further price increase in the near term.

Company to begin enrollment of  patients aged 1-3 years Expects data from younger cohort to be part of pivotal plans and BLA filing for broad label End-of-Phase II meeting with FDA scheduled for late July to finalize pivotal  program design Based on recent commercial landscape, confirmed accelerated approval pathway remains available given ongoing unmet need and RGX-202 differentiated design Remains on track to initiate pivotal trial in late Q3 to early Q4 2024 The next potential therapy to become available for Duchenne patients ROCKVILLE, Md., June 24, 2024 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced it initiated enrollment in a new cohort of patients ages 1-3 in its Phase I/II AFFINITY DUCHENNE® trial to evaluate the safety and efficacy of RGX-202 in boys with Duchenne muscular dystrophy (Duchenne).

Aligned with FDA on content of BLA and plans for submission: Submission of a rolling BLA using the accelerated approval pathway expected to start in Q3 2024 Confirmatory trial expected to begin in H2 2025 FDA confirmed RGX-121 commercial bulk drug is comparable to clinical material Positive biomarker, neurocognitive and systemic data will be part of BLA submission ROCKVILLE, Md. , June 18, 2024 /PRNewswire/ --  REGENXBIO Inc. (Nasdaq: RGNX) today announced it completed a successful Pre-Biologics License Application (BLA) meeting for RGX-121 for the treatment Mucopolysaccharidosis Type II (MPS II), where it finalized details of its BLA with the U.S. Food and Drug Administration (FDA).

REGENXBIO develops AAV therapies using its proprietary NAV platform, offering one-dose treatments targeting disease root causes. The company's pipeline includes promising candidates for age-related macular degeneration, Duchenne muscular dystrophy, and Hunter syndrome. ABBV-RGX-314, RGX-202, and RGX-121 are key pipeline candidates targeting significant markets with promising clinical data.

ROCKVILLE, Md. , June 5, 2024 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced it will participate in the Goldman Sachs 45th Annual Global Healthcare Conference on Wednesday, June 12, 2024.

On May 1, 2024, REGENXBIO Inc. (Nasdaq: RGNX) stated that it will be holding a conference call on May 8, 2024, at 4:30 p.m. in Rockville, Md.

ROCKVILLE, Md. , March 11, 2024 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced it will participate the following upcoming investor conferences: Leerink Partners 2024 Global Biopharma Conference Date: Tuesday, March 12, 2024 Location: Miami, FL 1x1 investor meetings only Barclays 26th Annual Global Healthcare Conference Fireside Chat: Wednesday, March 13, 2024 at 4:05 p.m.

Data from an early-stage study shows that treatment with REGENXBIO's (RGNX) investigational Duchenne therapy RGX-202 demonstrates early evidence of strength and motor function improvement.

Company to host webcast on Tuesday, March 5, 2024 at 8:30 a.m. EST Interim clinical data will be presented by Aravindhan Veerapandiyan, M.D.