ROCKVILLE, Md., Jan. 30, 2025 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced data from its RGX-121 (clemidsogene lanparvovec) program for the treatment of mucopolysaccharidosis type II (MPS II), also known as Hunter syndrome, will be shared at the 21st Annual WORLDSymposium™ 2025, taking place in San Diego, CA February 3-7, 2025. The following presentations include an encore of the topline results from the pivotal phase of the Phase I/II/III CAMPSIITE® trial of RGX-121. Abstract Title: Audiol ...

Regenxbio (RGNX) closed the last trading session at $7.95, gaining 1% over the past four weeks, but there could be plenty of upside left in the stock if short-term price targets set by Wall Street analysts are any guide. The mean price target of $36.36 indicates a 357.4% upside potential.The average comprises 11 short-term price targets ranging from a low of $22 to a high of $52, with a standard deviation of $9.66. While the lowest estimate indicates an increase of 176.7% from the current price level, the m ...

REGENXBIO to receive $110 million upfront, potential milestone payments of up to $700 million and meaningful double-digit royalties on net sales, and lead manufacturing Nippon Shinyaku to lead commercialization of first potential gene therapies for Mucopolysaccharidosis II (MPS II) and Mucopolysaccharidosis I (MPS I) in U.S. and Asia REGENXBIO retains rights to RGX-121 Priority Review Voucher (PRV) with potential accelerated approval expected in 2025; rolling BLA submission underway ROCKVILLE, Md., Jan. 1 ...

Alignment achieved with FDA on AFFINITY DUCHENNE® pivotal program and access to accelerated approval; BLA expected in 2026 Pivotal trial of RGX-202 is enrolling ambulatory patients aged 1 and above with first patient dosed Phase I/II data show RGX-202 recipients exceeding external natural history and established benchmarks for clinical outcomes Functional improvements seen in all patients treated with dose level 1 and dose level 2 at 12 and 9 months respectively New biomarker data confirms consistent robu ...

-       Event will feature Aravindhan Veerapandiyan, M.D., principal investigator of the AFFINITY DUCHENNE® trial and Michael Kelly, PhD, Chief Scientific Officer of CureDuchenneROCKVILLE, Md., Nov. 14, 2024 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced that it will host a webcast to discuss the AFFINITY DUCHENNE® pivotal program and new clinical data, including the first functional data from the ongoing Phase I/II study of RGX-202, the company's next-generation gene therapy for the treatmen ...

Call Start: 16:30 January 1, 0000 5:24 PM ET REGENXBIO Inc. (NASDAQ:RGNX) Q3 2024 Earnings Call November 6, 2024 16:30 ET Company Participants Patrick Christmas - Chief Legal Officer Curran Simpson - President and Chief Executive Officer Mitchell Chan - Chief Financial Officer Steve Pakola - Chief Medical Officer Conference Call Participants Gospel Enyindah-Asonye - Morgan Stanley Mani Foroohar - Leerink Partners Jack Padovano - Stifel Luca Issi - RBC Capital Markets Paul Choi - Goldman Sachs Daniil Gatauli ...

Regenxbio (RGNX) came out with a quarterly loss of $1.17 per share versus the Zacks Consensus Estimate of a loss of $1.16. This compares to loss of $1.41 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of -0.86%. A quarter ago, it was expected that this biotechnology company would post a loss of $1.29 per share when it actually produced a loss of $1.05, delivering a surprise of 18.60%.Over the last four quarters, the company has ...

Table of Contents Securities registered pursuant to Section 12(b) of the Act: UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 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 Re ...

EXHIBIT 99.1 REGENXBIO Reports Third Quarter 2024 Financial Results and Recent Operational Updates • Advancement in Phase I/II AFFINITY DUCHENNE ®trial of RGX-202 for Duchenne Muscular Dystrophy; pivotal trial initiation and first functional data expected this month • BLA submission for RGX-121 initiated and expected to complete in Q1 2025 • Positive Phase II data support bilateral administration of subretinal ABBV-RGX-314; data consistent with that from multiple previous studies demonstrating favorable saf ...

Advancement in Phase I/II AFFINITY DUCHENNE® trial of RGX-202 for Duchenne Muscular Dystrophy; pivotal trial initiation and first functional data expected this month BLA submission for RGX-121 initiated and expected to complete in Q1 2025 Positive Phase II data support bilateral administration of subretinal ABBV-RGX-314; data consistent with that from multiple previous studies demonstrating favorable safety and efficacy profile End-of-Phase II meeting for ABBV-RGX-314 in diabetic retinopathy accelerated to ...