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.
REGENXBIO Inc. (Nasdaq: RGNX) announced key presentations at the Society for the Study of Inborn Errors of Metabolism Annual Symposium from August 30 to September 2, 2022, in Freiburg, Germany. The focus will be on new data from the Phase I/II/III CAMPSIITE™ trial of RGX-121, a gene therapy for Mucopolysaccharidosis Type II, and RGX-111 for Mucopolysaccharidosis Type I. Notable presentations include interim analyses by Dr. Roberto Giugliani and Dr. Raymond Wang, as well as a discussion on neurodevelopment in MPS II by Dr. Maria Escolar.
REGENXBIO Inc. (Nasdaq: RGNX) will present at the H.C. Wainwright 2nd Annual Ophthalmology Virtual Conference on August 17, 2022, at 11:00 a.m. ET. The panel will focus on Unique Delivery Technology Platforms for Better Compliance and Efficacy. A live webcast will be accessible on the company's website, followed by an archived replay for 30 days. REGENXBIO is a clinical-stage biotechnology company harnessing gene therapy through its proprietary NAV Technology Platform, which includes over 100 exclusive AAV vectors, supporting its goal of advancing five AAV Therapeutics by 2025.
REGENXBIO announced its Q2 2022 financial results, reporting revenues of $32.6 million, driven by Zolgensma royalty revenues, up from $22.0 million in Q2 2021. The net loss increased to $68.2 million, or $1.58 per share, compared to $57.6 million a year ago. Key developments include progress in the RGX-314 program for wet AMD and diabetic retinopathy, with BLA filings anticipated in 2024. The company holds $682 million in cash, providing operational runway into 2025, supporting its '5x'25 strategy to have five gene therapies on the market or in late-stage development by 2025.
REGENXBIO (Nasdaq: RGNX) announced plans to file a Biologics License Application (BLA) for RGX-121 in 2024, seeking FDA's accelerated approval for treating Mucopolysaccharidosis Type II (MPS II). The pivotal CAMPSIITE trial is actively enrolling patients aged 4 months to 5 years. RGX-121, a one-time gene therapy, aims to provide a new treatment option as current therapies are inadequate. Preliminary trial results show a well-tolerated treatment with potential positive effects on neurodevelopmental function and significant reductions in glycosaminoglycans (GAGs) in cerebrospinal fluid.
REGENXBIO Inc. (Nasdaq: RGNX) will conduct a conference call on August 3, 2022, at 4:30 p.m. ET to discuss its financial results for the quarter ended June 30, 2022, along with recent operational highlights. Investors and analysts can register for the event via the provided links. REGENXBIO is focused on gene therapy, employing its NAV Technology Platform, which includes over 100 AAV vectors. The company aims to advance five AAV therapeutics into pivotal-stage or commercial products by 2025.
REGENXBIO (Nasdaq: RGNX) has completed enrollment in Cohort 5 of the Phase II AAVIATE trial, evaluating RGX-314 for wet age-related macular degeneration (wet AMD) via suprachoroidal delivery. This marks 85 subjects dosed across five cohorts. The company anticipates releasing additional suprachoroidal data within the year. RGX-314 aims to provide a one-time, in-office treatment option for patients facing vision loss. The trial compares RGX-314 with standard anti-VEGF therapies. REGENXBIO is committed to advancing its gene therapy platform targeting significant retinal diseases.
REGENXBIO Inc. (Nasdaq: RGNX) has inaugurated its new Manufacturing Innovation Center in Montgomery County, Maryland, investing $65 million to enhance gene therapy manufacturing capabilities. This facility will produce NAV Technology-based AAV gene therapies at a scale of up to 2,000 liters. It aims to streamline the transition from research to clinical and commercial readiness, supporting REGENXBIO's goal to develop five AAV therapeutics by 2025. The center is designed to meet global regulatory standards and features advanced production and quality control facilities.
REGENXBIO Inc. (Nasdaq: RGNX) appointed Jennifer Zachary to its Board of Directors effective June 3, 2022. With over 20 years of experience in the pharmaceutical and medical device industries, she will also serve on the Audit Committee. Zachary, currently the Executive Vice President and General Counsel of Merck, brings significant legal and regulatory expertise. Her addition is seen as pivotal for REGENXBIO as it implements its '5x'25' strategy aimed at advancing five AAV Therapeutics to pivotal or commercial stages by 2025.
REGENXBIO (RGNX) reports Q1 2022 financial results, highlighting a revenue increase to $22.2 million, primarily from Zolgensma royalties. The company has $765 million in cash, providing operational runway into 2025. Key developments include ongoing enrollment in pivotal trials for RGX-314 targeting wet AMD and diabetic retinopathy, and delayed initiation of the AFFINITY DUCHENNE trial. The in-house cGMP facility is now operational, enhancing manufacturing capacity. CEO Kenneth T. Mills expresses optimism about advancing five AAV Therapeutics into pivotal stages by 2025.
REGENXBIO Inc. (Nasdaq: RGNX) announced its participation in two upcoming investor conferences. The Bank of America Securities 2022 Healthcare Conference will take place on May 10, 2022, at the Encore Hotel in Las Vegas, with a presentation scheduled for 4:00 p.m. PT. The UBS Global Healthcare Conference 2022 is set for May 24, 2022, at Lotte New York Palace, with a presentation at 10:45 a.m. ET. Webcasts of both events will be available on the REGENXBIO website for approximately 30 days following their presentations.