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 has received FDA clearance for its IND application to initiate the clinical trial of RGX-202, a novel gene therapy targeting Duchenne muscular dystrophy. This therapy utilizes a microdystrophin transgene delivered through the proprietary NAV® AAV8 vector. The AFFINITY DUCHENNE trial will test the safety and efficacy of RGX-202 in pediatric patients, with dosing expected to start in the first half of 2022. The trial incorporates an innovative design with a comprehensive immunosuppressive regimen to enhance safety and tolerability.
On November 22, 2021, REGENXBIO announced the FDA granted Orphan Drug Designation for RGX-202, a potential one-time gene therapy targeting Duchenne muscular dystrophy. RGX-202 features a novel microdystrophin transgene aimed at enhancing muscle resistance to damage. The company plans to submit an Investigational New Drug (IND) application by year-end 2021. Commercial-scale cGMP material has been produced, supporting clinical development. Orphan drug status provides key advantages like tax credits and marketing exclusivity.
REGENXBIO announced positive interim data from Phase II trials of RGX-314 for treating wet AMD and diabetic retinopathy. The AAVIATE trial showed RGX-314 was well tolerated among 50 patients, with no serious adverse events. In Cohort 2, a 71.8% reduction in anti-VEGF treatment burden was observed, with 40% of patients injection-free. Cohort 1 of the ALTITUDE trial reported stable visual acuity at three months. These results were presented at the AAO 2021 Annual Meeting, highlighting RGX-314's potential in retinal disease management.
REGENXBIO (Nasdaq: RGNX) has finalized a collaboration and license agreement with AbbVie for the gene therapy RGX-314, targeting wet AMD and diabetic retinopathy. The deal includes a $370 million upfront payment and potential earnings of up to $1.38 billion based on future milestones. REGENXBIO will manage ongoing trials, while AbbVie will lead global clinical development and commercialization. Both companies will share profits from U.S. sales equally, with tiered royalties on international sales. RGX-314 aims to inhibit VEGF, which contributes to retinal fluid accumulation.
REGENXBIO Inc. (Nasdaq: RGNX) announced its participation in two upcoming virtual investor conferences. The Barclays Gene Editing & Gene Therapy Summit is set for November 15, 2021, at 1:30 p.m. ET. Additionally, the Piper Sandler 33rd Annual Virtual Healthcare Conference will take place on December 2, 2021, with a recorded fireside chat available starting November 22, 2021, at 10:00 a.m. ET. A live webcast and recorded presentations can be accessed via REGENXBIO's website for 30 days post-event.
REGENXBIO Inc. (Nasdaq: RGNX) announced that data from its RGX-314 clinical trials will be presented at the American Academy of Ophthalmology 2021 Annual Meeting in New Orleans, LA, from November 12-15, 2021. RGX-314, a potential one-time gene therapy targeting wet age-related macular degeneration and diabetic retinopathy, will be showcased in an oral presentation by Dr. Robert L. Avery on November 12. The therapy utilizes the NAV AAV8 vector to inhibit VEGF, potentially preventing fluid accumulation in the retina.
REGENXBIO and AbbVie announced a strategic collaboration to develop RGX-314, focusing on wet AMD and diabetic retinopathy, with REGENXBIO receiving a $370 million upfront payment. The partnership aims to leverage both companies' expertise for potential milestone payments totaling $1.38 billion. Positive Phase II trial data for RGX-314 showed stable visual acuity and reduced treatment burden. Financially, REGENXBIO reported $30.8 million in Q3 revenues, down from $98.9 million the same period in 2020, and a net loss of $58.4 million. Cash reserves were $533.5 million as of September 30, 2021.
REGENXBIO Inc. (Nasdaq: RGNX) announced a conference call scheduled for November 2, 2021, at 4:30 p.m. ET. The call will cover the company's financial results for the quarter ended September 30, 2021, and recent operational highlights. Investors can access the call via phone or a webcast on the REGENXBIO website. The company is focused on gene therapy through its NAV® Technology Platform, which includes over 100 exclusive AAV vectors aimed at various therapeutic areas.
REGENXBIO announced positive interim data from the Phase II ALTITUDE trial of RGX-314, a gene therapy for diabetic retinopathy (DR). In Cohort 1, 33% of patients showed a two-step improvement in DR severity after three months, compared to none in the control group. The treatment was well-tolerated with no serious drug-related adverse events. Cohorts 2 and 3 are ongoing at a higher dose of 5x1011 GC/eye. This therapy could significantly benefit the approximately eight million people affected by DR in the U.S.
REGENXBIO (Nasdaq: RGNX) announced positive initial data from the Phase II AAVIATE trial of RGX-314 for wet AMD treatment via suprachoroidal delivery. In Cohort 1, 14 patients showed stable visual acuity and retinal thickness at six months, with a 75.9% reduction in anti-VEGF injections. No drug-related serious adverse events were reported among 50 patients in Cohorts 1-3. The trial is expanding to include a third dose level of RGX-314. A conference call featuring key opinion leaders will provide further insights.