Life sciences veteran Mitchell Chan joins the company ahead of multiple catalysts across late-stage gene therapy programs Vit Vasista steps down following more than 15 years at the Company ROCKVILLE, Md., Sept. 17, 2024 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced that Mitchell Chan has been appointed as Executive Vice President and Chief Financial Officer, effective today. A veteran finance executive and operating partner in the biotechnology industry, Mr. Chan has held key roles in raisin ...

- Data from pivotal dose level demonstrates long-term, sustained reductions in CSF levels of HS D2S6, a key biomarker of brain disease in MPS II - 80% of patients who received the pivotal dose discontinued intravenous enzyme replacement therapy or remained treatment-naïve - Submission of a rolling BLA using the accelerated approval pathway on track for Q3 2024 ROCKVILLE, Md., Sept. 3, 2024 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced positive results from the Phase I/II/III CAMPSIITE® trial ...

ROCKVILLE, Md., Aug. 29, 2024 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced it will participate the following upcoming investor conferences: Morgan Stanley 22nd Annual Global Healthcare Conference Fireside Chat: Thursday, September 5, 2024 at 5:35 p.m. ET Location: New York, NY Baird 2024 Global Healthcare Conference Fireside Chat: Wednesday, September 11, 2024 at 9:40 a.m. ET Location: New York, NY Live webcasts of the fireside chats at the Morgan Stanley and Baird conferences can be access ...

ROCKVILLE, Md., Aug. 8, 2024 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced it will participate in the H.C. Wainwright 4th Annual Ophthalmology Virtual Conference on Thursday, August 15, 2024. H.C. Wainwright 4th Annual Ophthalmology Virtual Conference Panel: The Evolving Therapeutic Landscape of AMD Date/Time: Thursday, August 15, 2024 at 9:00 a.m. EDT Location: Virtual A live webcast of the panel can be accessed in the Investors section of REGENXBIO's website at www.regenxbio.com. An archiv ...

Shares of Regenxbio (RGNX) have gained 17.7% over the past four weeks to close the last trading session at $12.51, but there could still be a solid upside left in the stock if short-term price targets of Wall Street analysts are any indication. Going by the price targets, the mean estimate of $41.83 indicates a potential upside of 234.4%. The average comprises 12 short-term price targets ranging from a low of $28 to a high of $61, with a standard deviation of $9.47. While the lowest estimate indicates an in ...

Regenxbio (RGNX) came out with a quarterly loss of $1.05 per share versus the Zacks Consensus Estimate of a loss of $1.29. This compares to loss of $1.66 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of 18.60%. A quarter ago, it was expected that this biotechnology company would post a loss of $1.28 per share when it actually produced a loss of $1.38, delivering a surprise of -7.81%. Over the last four quarters, the company ha ...

Core Insights - REGENXBIO Inc. reported positive interim safety and efficacy data from the Phase I/II AFFINITY DUCHENNE trial of RGX-202 for Duchenne muscular dystrophy, showing robust microdystrophin expression levels in treated patients [1][3][5] - The company plans to initiate a pivotal trial in Q4 2024 and expects to complete enrollment in the dose level 2 expansion cohort early in Q3 2024 [1][7] Company Overview - REGENXBIO is a clinical-stage biotechnology company focused on gene therapy, with a proprietary NAVXpress™ platform for manufacturing [10][12] - RGX-202 is a one-time AAV therapeutic designed to deliver a novel microdystrophin gene, which is the only gene therapy in development for Duchenne that encodes for the C-Terminal domain [2][10] Clinical Trial Details - The AFFINITY DUCHENNE trial is a multicenter, open-label study evaluating the safety, tolerability, and clinical efficacy of RGX-202 in patients aged 1-11 years [8][9] - Initial results showed microdystrophin expression levels of 77.2% and 46.5% in patients aged 5.8 and 8.5 years, respectively, compared to control [4][5] Manufacturing and Capacity - RGX-202 is manufactured at the REGENXBIO Manufacturing Innovation Center, which has the capacity to produce up to 2,500 doses per year using a scalable suspension-based process [6][10] Future Expectations - The company anticipates sharing initial strength and functional assessment data for both dose levels of the AFFINITY DUCHENNE trial in the second half of 2024 [7]

REGENXBIO is a leading clinical-stage biotechnology company seeking to improve lives through the curative potential of gene therapy. Since its founding in 2009, REGENXBIO has pioneered the development of AAV Therapeutics, an innovative class of gene therapy medicines. REGENXBIO is advancing a pipeline of AAV Therapeutics for retinal and rare diseases, including ABBV-RGX-314 for the treatment of wet AMD and diabetic retinopathy, being developed in collaboration with AbbVie, RGX-202 for the treatment of Duche ...

Regenxbio (RGNX) shares rallied 18.3% in the last trading session to close at $12.71. This move can be attributable to notable volume with a higher number of shares being traded than in a typical session. This compares to the stock's 18.3% loss over the past four weeks. For Regenxbio, the consensus EPS estimate for the quarter has remained unchanged over the last 30 days. And a stock's price usually doesn't keep moving higher in the absence of any trend in earnings estimate revisions. So, make sure to keep ...

Regenxbio (RGNX) shares ended the last trading session 6.4% higher at $12.79. The jump came on an impressive volume with a higher-than-average number of shares changing hands in the session. This compares to the stock's 19.4% loss over the past four weeks. Earlier this month, the company completed a successful pre-biologics license application (BLA) meeting with the FDA for its pipeline candidate, RGX-121, which is being developed for the treatment of Mucopolysaccharidosis Type II (MPS II). The company expe ...