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 (NASDAQ: RGNX) announced a conference call scheduled for February 28, 2023, at 4:30 p.m. ET. This call will cover the company’s financial results for Q4 and the full year ended December 31, 2022, along with recent operational highlights.
REGENXBIO, a clinical-stage biotechnology company, focuses on gene therapy through its proprietary NAV Technology Platform, which comprises over 100 novel AAV vectors. The company aims to advance five AAV Therapeutics into pivotal-stage or commercial products by 2025.
REGENXBIO Inc. (RGNX) announced new interim data from trials of its gene therapies RGX-121 and RGX-111 for MPS II and MPS I, respectively. These results will be showcased at the 19th Annual WORLD Symposium™ from February 22-26, 2023, in Orlando, Florida. The company will present three oral and eight poster presentations, including interim analyses from both clinical trials. Additionally, REGENXBIO will host a symposium session on February 24, discussing AAV gene therapy for neuronopathic MPS II. The event underscores REGENXBIO's commitment to advancing gene therapy solutions and enhancing treatment options for rare diseases.
REGENXBIO (RGNX) announced promising interim results from a Phase II bridging study of RGX-314, a gene therapy for wet AMD, using its NAVXpress manufacturing platform. The study involved 60 patients and highlighted that RGX-314 produced via this new process showed similar safety and efficacy profiles to prior methods. The company aims for these results to support Biologics License Application (BLA) submission in 2024. With no severe adverse events linked to RGX-314, the therapy may significantly reduce treatment burdens for patients. A live webcast discussing these findings occurred on February 11, 2023, showcasing advancements toward RGX-314's commercialization.
REGENXBIO Inc. (Nasdaq: RGNX) announced its participation in the SVB Securities Global Biopharma Conference on February 16, 2023, at 12:00 p.m. ET. A live webcast will be available on the company's website, with a replay archived for 30 days. REGENXBIO is a biotechnology company focused on gene therapy, utilizing its proprietary NAV Technology Platform, which includes over 100 AAV vectors for therapeutic development. The company aims to advance five AAV Therapeutics into pivotal or commercial stages by 2025, under its "strategy.
This engagement highlights the company's commitment to innovation and progress in biotechnology.
REGENXBIO Inc. (NASDAQ: RGNX) announced three key presentations on RGX-314 at the Angiogenesis, Exudation, and Degeneration 2023 Conference, scheduled for February 10-11, 2023. These presentations will showcase data from a Phase II bridging study assessing RGX-314's pharmacodynamics, safety, and efficacy for treating neovascular age-related macular degeneration (AMD), utilizing cGMP material from the NAVXpress™ platform. Presenters include Dr. Charles Wykoff, Dr. Allen Ho, and Dr. Peter Campochiaro, highlighting long-term follow-up and new delivery methods for AMD and diabetic retinopathy, which could support RGX-314's future commercialization.
REGENXBIO has commenced the Phase I/II AFFINITY DUCHENNE trial for RGX-202 to treat Duchenne muscular dystrophy. This innovative gene therapy utilizes a novel microdystrophin and the NAV® AAV8 vector, aiming to improve muscle strength in affected boys. The trial will evaluate safety, tolerability, and efficacy with a focus on pediatric patients aged 4 to 11. Additionally, REGENXBIO is enrolling patients for the observational AFFINITY BEYOND study, which aims to assess AAV8 antibody prevalence. This initiative aligns with the company's '5x'25' strategy to advance five gene therapies by 2025, highlighting a commitment to addressing unmet medical needs in the Duchenne community.
REGENXBIO Inc. (Nasdaq: RGNX) announced leadership promotions, appointing Curran Simpson as Chief Operating Officer and Shiva Fritsch as Chief Communications Officer. These changes follow a transformative year for the company, including the launch of a gene therapy Manufacturing Innovation Center and progress under the '5 x '25' initiative to advance five AAV therapeutics into pivotal stages by 2025. Simpson, with extensive biopharmaceutical experience, will oversee critical operational functions, while Fritsch will manage communications and human resources.
REGENXBIO Inc. (Nasdaq: RGNX) announced it will present at the 41st Annual J.P. Morgan Healthcare Conference on January 10, 2023, at 11:15 a.m. PT in San Francisco, CA. The presentation will include a live webcast accessible on the company's website, with an archive available for 30 days after the event. REGENXBIO is focused on gene therapy, utilizing its proprietary NAV Technology Platform and aims to progress five AAV Therapeutics into pivotal or commercial stages by 2025.
REGENXBIO Inc. (Nasdaq: RGNX) has announced progress on its AAV Therapeutics for treating CLN2 disease, the most common form of Batten disease. The first patient has been dosed with RGX-181 in a Brazil-based study, showing no severe adverse effects. Additionally, REGENXBIO received approval for RGX-381 from the UK Health Authority, with plans for a Phase I/II clinical trial in the first half of 2023. Both therapies aim to provide long-term benefits for patients suffering from debilitating neurodegenerative symptoms related to CLN2 disease.
REGENXBIO (RGNX) announced the completion of dosing in the expanded Cohort 2 of its Phase I/II trial for RGX-111, an investigational gene therapy for severe Mucopolysaccharidosis Type I (MPS I). Eight patients have participated in this trial, aimed at evaluating RGX-111's safety and potential effectiveness. The company plans to manufacture commercial-grade material to further develop RGX-111. Interim trial updates are expected in the first half of 2023. RGX-111 leverages the NAV AAV9 vector to deliver the IDUA gene directly to the CNS.