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 two oral presentations at the AAO 2020 Annual Meeting (Nov 13-15) focused on their gene therapy for wet AMD. The first presentation will highlight the RGX-314 Phase I/II trial results, presented by Dr. Dante Pieramici. The second presentation, by Dr. Peter Campochiaro, will cover preclinical studies on suprachoroidal delivery of RGX-314. REGENXBIO aims to leverage its NAV Technology Platform for advancing gene therapy solutions across various therapeutic areas.
REGENXBIO Inc. (Nasdaq: RGNX) announces participation in upcoming virtual investor conferences. Key events include the 29th Annual Credit Suisse Virtual Healthcare Conference on November 12, 2020, at 8:45 a.m. ET, and the Barclays Gene Editing & Gene Therapy Summit on November 16, 2020, at 2:00 p.m. ET. Live webcasts will be available on REGENXBIO's website, with archived replays accessible for approximately 30 days post-presentation. The company focuses on gene therapy and has a broad pipeline utilizing its proprietary NAV Technology Platform.
REGENXBIO Inc. (RGNX) announced its Q3 2020 financial results, highlighting a significant revenue increase to $98.9 million, driven by Zolgensma royalties and an $80 million milestone payment. The company reported a net income of $8.8 million, reversing a loss from the previous year. Operational achievements include the initiation of Phase II trials for RGX-314 targeting wet AMD and diabetic retinopathy. Additionally, RGX-121's program expansion for MPS II patients was noted. Cash and equivalents stood at $289.8 million, ensuring funding through mid-2022.
REGENXBIO (Nasdaq: RGNX) will host a conference call on November 4, 2020, at 4:30 p.m. ET to discuss its financial results for the third quarter ended September 30, 2020. The company aims to enhance lives through gene therapy using its proprietary NAV Technology Platform. Investors can access the call by phone or through a webcast available for 30 days. The platform includes over 100 novel AAV vectors, showcasing the company's commitment to developing a diverse pipeline of gene therapy candidates.
REGENXBIO Inc. (Nasdaq: RGNX) announced it will receive an $80 million milestone payment from Novartis AG due to Zolgensma achieving $1 billion in net sales. This revenue is expected to be recognized in Q3 2020. Zolgensma, a transformative gene therapy for spinal muscular atrophy, has positively impacted over 700 patients. Since its FDA approval in May 2019, REGENXBIO has received over $140 million from related royalties and milestones.
REGENXBIO Inc. (Nasdaq: RGNX) announced an expansion of its RGX-121 program for Mucopolysaccharidosis Type II (MPS II), aiming to understand the disease's neurodegenerative effects better. RGX-121, a potential gene therapy, delivers the enzyme iduronate-2-sulfatase to the central nervous system. An ongoing Phase I/II trial has dosed six patients with no serious adverse events reported. Additionally, the FDA has cleared a new IND for a trial involving pediatric patients aged 5-18. A natural history study will explore neurocognitive development in young MPS II patients.
REGENXBIO Inc. (Nasdaq: RGNX), a clinical-stage biotechnology company, announced its participation in three upcoming virtual investor conferences. These include the SVB Leerink CybeRx Series on October 1, 2020, the Jefferies Virtual Gene Therapy/Editing Summit on October 2, 2020, and the Chardan Virtual 4th Annual Genetic Medicines Conference on October 6, 2020, featuring a fireside chat at 10:30 a.m. ET. Investors can access a live webcast and a 30-day archived replay on the company's website.
REGENXBIO Inc. (Nasdaq: RGNX) has announced the dosing of its first patient in the AAVIATE trial, a Phase II study evaluating the suprachoroidal delivery of RGX-314 for treating wet age-related macular degeneration (wet AMD). This trial marks a significant milestone as it is the first to assess this delivery method for gene therapy. Interim data is expected by the end of 2020. RGX-314 aims to serve as a one-time treatment targeting the VEGF pathway to inhibit leaky blood vessel growth, addressing a condition affecting millions.
REGENXBIO Inc. (Nasdaq: RGNX), a leader in gene therapy, announced its participation in two September investor conferences. The events will be held virtually, starting with Citi's 15th Annual BioPharma Virtual Conference on September 9, 2020, followed by the Morgan Stanley 18th Annual Global Healthcare Conference on September 15, 2020, including a fireside chat at 8:45 a.m. ET. Interested investors can access a live webcast on REGENXBIO's website, with a replay available for 30 days post-event.
REGENXBIO Inc. (Nasdaq: RGNX) announced the FDA's clearance of its Investigational New Drug (IND) application for RGX-314 to treat diabetic retinopathy (DR). This IND activation allows the company to commence a Phase II trial named ALTITUDE in the second half of 2020, targeting around 40 patients. The primary endpoint is to evaluate patient improvement in DR severity after 48 weeks. This advancement is significant as DR is a major cause of blindness, affecting approximately 8 million people in the U.S.