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 its participation in two investor conferences. The first is the Piper Sandler 34th Annual Healthcare Conference on December 1, 2022, at 9:10 a.m. ET in New York, NY. The second event is the BofA Securities 2022 Virtual Biotech SMID Cap Conference, with a fireside chat on December 8, 2022, at 10:50 a.m. ET. Live webcasts can be accessed on REGENXBIO's website, with replays available for 30 days. The company is a leader in gene therapy, focusing on advancing its 5x'25 strategy to develop five AAV Therapeutics by 2025.
REGENXBIO (Nasdaq: RGNX) reported third-quarter financial results, highlighting a net loss of $75.5 million, compared to a $58.4 million loss in Q3 2021. Revenues decreased to $26.5 million, chiefly due to falling Zolgensma royalties. The company maintains a robust cash position of $617 million, expected to fund operations through 2025. Progress on the 5x25 strategy continues, with RGX-314 trials for wet AMD and diabetic retinopathy demonstrating positive interim data. BLA filings for RGX-314 and RGX-121 are anticipated in 2024, affirming ongoing commitment to gene therapies.
REGENXBIO (Nasdaq: RGNX) announced positive interim results from the Phase II ALTITUDE trial of RGX-314, aimed at treating diabetic retinopathy (DR) via suprachoroidal delivery. The results showed that RGX-314 was well tolerated in 50 patients across the first three cohorts, with no serious drug-related adverse events. Clinically meaningful improvements were noted, including 54% of patients achieving any DRSS improvement, compared to 20% in the control group. The trial will expand to include a third dose level and new cohorts, with the goal of further evaluating RGX-314's potential.
REGENXBIO Inc. (Nasdaq: RGNX) has announced its participation in two upcoming investor conferences. The first is the Credit Suisse 31st Annual Healthcare Conference on November 8, 2022, located at Terranea Resort, Rancho Palos Verdes, CA. The second is the Barclays Sixth Annual Gene Editing/Therapy Summit on November 14, 2022, where REGENXBIO will discuss AAV Gene Therapy's current status and future direction at 2:50 p.m. ET. The company focuses on advancing AAV Therapeutics with its proprietary NAV Technology Platform, emphasizing its goal of progressing five products to pivotal-stage or commercial status by 2025.
REGENXBIO Inc. (Nasdaq: RGNX) announced it will present data from the Phase II ALTITUDE trial for RGX-314 aimed at treating diabetic retinopathy at the Retina Society Annual Scientific Meeting from November 2-5, 2022, in Pasadena, CA. A conference call is scheduled for November 3, 2022, at 8:30 a.m. ET to discuss Q3 2022 financial results and operational highlights. The presentation will be led by Dr. Lejla Vajzovic of Duke University on November 2, 2022, at 4:41 p.m. PT, and will be accessible on REGENXBIO's website.
REGENXBIO Inc. (Nasdaq: RGNX) announced positive interim data from the Phase II AAVIATE trial of RGX-314 for wet AMD, showing significant reductions in treatment burden. The trial reported an 85% reduction at the third dose level, with 67% of patients in Cohort 4 injection-free. Safety profiles were favorable with no serious drug-related adverse events. Positive long-term data from Phase I/IIa studies showed RGX-314 remains well tolerated and supports a BLA submission expected in 2024. Upcoming data from the ALTITUDE trial for diabetic retinopathy is anticipated at the Retina Society meeting in November.
REGENXBIO Inc. (Nasdaq: RGNX) announced its participation in Chardan's 6th Annual Genetic Medicines Conference on October 4, 2022, at 1:30 p.m. ET in New York, NY. The company will conduct a fireside chat, accessible via a live webcast on its website, with an archived version available for about 30 days post-event. REGENXBIO is recognized for its gene therapy advancements, utilizing its proprietary NAV Technology Platform comprising over 100 AAV vectors. The firm aims to progress five gene therapy programs into pivotal stages or commercial products by 2025.
REGENXBIO Inc. (Nasdaq: RGNX) will present at the American Academy of Ophthalmology 2022 Annual Meeting from September 30 to October 3 in Chicago, IL. Key presentations include updates on RGX-314, an investigational gene therapy for chronic retinal conditions, including wet age-related macular degeneration and diabetic retinopathy. The company will also host a conference call on October 3 at 8:30 a.m. ET to discuss interim data from its ongoing Phase II AAVIATE trial.
REGENXBIO Inc. (Nasdaq: RGNX) has announced its participation in two key investor conferences:
- Morgan Stanley 20th Annual Global Healthcare Conference on September 14, 2022, at 2:55 p.m. ET in New York.
- UBS Biotech South Beach Conference on September 29, 2022, in Miami.
A live webcast of the Morgan Stanley conference will be available on REGENXBIO's website with a 30-day archived replay. The company is committed to advancing gene therapy through its proprietary NAV Technology Platform and aims to progress five AAV Therapeutics by 2025.
REGENXBIO (Nasdaq: RGNX) announced positive interim data for RGX-121, a gene therapy for Mucopolysaccharidosis Type II (MPS II), at the SSIEM Annual Symposium. The Phase I/II/III CAMPSIITE trial revealed significant median reductions in cerebrospinal fluid (CSF) glycosaminoglycans (GAGs) at 48 weeks, demonstrating a favorable safety profile with no serious drug-related adverse events. The company plans to file a Biologics License Application in 2024 via the accelerated approval pathway, aiming to address significant unmet needs in MPS II treatment.