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) has announced its participation in three major healthcare investor conferences in late 2024. The company will present at the UBS Global Healthcare Conference on November 13 in Rancho Palos Verdes, the Stifel Healthcare Conference on November 19 in New York, and the Piper Sandler Annual Healthcare Conference on December 5 in New York. All presentations will be available via live webcast through REGENXBIO's website, with recordings accessible for approximately 30 days after each event.
REGENXBIO (Nasdaq: RGNX) has scheduled a conference call for Wednesday, November 6, at 4:30 p.m. ET to present its Q3 2024 financial results and recent operational highlights. The call will include a question-and-answer session for analysts, and participants are advised to join 15 minutes before the start time. A webcast replay will be available on the company's investor website approximately two hours after the call ends.
REGENXBIO (Nasdaq: RGNX) presented positive data from the Phase II fellow eye sub-study of subretinal ABBV-RGX-314 in patients with bilateral wet age-related macular degeneration (wet AMD) at the American Academy of Ophthalmology (AAO) meeting. Key findings at nine months post-administration include:
- 97% reduction in annualized anti-VEGF treatment burden
- 100% of patients required either zero or one supplemental injection
- 78% of patients were completely injection-free
The treatment was well-tolerated with no drug-related serious adverse events and no cases of intraocular inflammation. Patients demonstrated sustained best-corrected visual acuity (BCVA) and central retinal thickness (CRT). The data highlight the potential of ABBV-RGX-314 as a one-time effective treatment option for patients with bilateral wet AMD.
REGENXBIO Inc. (Nasdaq: RGNX) has announced upcoming presentations of new interim data for ABBV-RGX-314 at the American Academy of Ophthalmology 2024 annual meeting. ABBV-RGX-314 is an investigational one-time AAV Therapeutic being developed in collaboration with AbbVie for treating wet age-related macular degeneration (wet AMD), diabetic retinopathy, and other chronic retinal conditions.
The presentations will include:
- New results from a bilateral dosing study using subretinal delivery for wet AMD
- Data from a Phase 2 dose-escalation study evaluating suprachoroidal delivery for diabetic retinopathy
- Long-term follow-up results from the Phase I/IIa subretinal delivery program in wet AMD
These presentations will provide insights into the potential efficacy and safety of ABBV-RGX-314 across different delivery methods and retinal conditions.
REGENXBIO Inc. (Nasdaq: RGNX) has announced its participation in Chardan's 8th Annual Genetic Medicines Conference on Monday, September 30, 2024. The event will take place in New York, NY, featuring a fireside chat at 8:30 a.m. ET.
Investors and interested parties can access a live webcast of the fireside chat through the Investors section of REGENXBIO's website at www.regenxbio.com. An archived replay of the webcast will be available for approximately 30 days following the presentation, allowing those unable to attend the live event to catch up on the discussion.
This conference participation highlights REGENXBIO's ongoing engagement with the investment community and its commitment to sharing insights into its work in the field of genetic medicines.
REGENXBIO Inc. (Nasdaq: RGNX) has appointed Mitchell Chan as Executive Vice President and Chief Financial Officer, effective September 17, 2024. Chan, a veteran finance executive with nearly 20 years of experience in the biotechnology industry, succeeds Vit Vasista, who served as CFO since 2009. Chan's extensive background includes key roles in capital raising, business development, and operations, most recently serving as Operating Partner at Catalio Capital Management. His appointment comes at a important time for REGENXBIO as the company advances its product pipeline towards commercialization.
Chan's previous experience includes serving as CFO of Viela Bio, where he oversaw a successful IPO and $3B acquisition by Horizon Therapeutics. He has also held leadership roles at AstraZeneca and Genentech-Roche. Vasista will remain as an advisor to REGENXBIO through January 3, 2025, to ensure a smooth transition.
REGENXBIO (Nasdaq: RGNX) announced positive results from the Phase I/II/III CAMPSIITE® trial of RGX-121 for treating Mucopolysaccharidosis Type II (MPS II), or Hunter syndrome. The pivotal dose level demonstrated an 85% median reduction in cerebrospinal fluid levels of heparan sulfate D2S6, a key biomarker of brain disease activity, sustained for up to two years. Notably, 80% of patients at the pivotal dose level were enzyme replacement therapy (ERT)-free at the last time point, up to 18 months post-dosing.
The trial met its primary endpoint with statistical significance, and patients exceeded expectations in neurodevelopmental function compared to natural history data. REGENXBIO plans to initiate a rolling Biologics License Application submission using the accelerated approval pathway in Q3 2024, potentially leading to a Priority Review Voucher in 2025.
REGENXBIO Inc. (Nasdaq: RGNX) has announced its participation in two upcoming investor conferences. The company will be present at the Morgan Stanley 22nd Annual Global Healthcare Conference on September 5, 2024, at 5:35 p.m. ET, and the Baird 2024 Global Healthcare Conference on September 11, 2024, at 9:40 a.m. ET. Both events will take place in New York, NY.
Investors can access live webcasts of the fireside chats from both conferences through the Investors section of REGENXBIO's website. Archived replays will be available for approximately 30 days after each presentation. This participation in high-profile healthcare conferences suggests REGENXBIO's commitment to engaging with investors and showcasing its developments in the biotechnology sector.
REGENXBIO Inc. (Nasdaq: RGNX) has announced that data from its RGX-121 program for the treatment of mucopolysaccharidosis type II (MPS II), also known as Hunter syndrome, will be presented at the SSIEM 2024 Annual Symposium in Porto, Portugal from September 3-6, 2024. The presentation, titled 'CAMPSIITE™ phase I/II/III: Interim clinical update of RGX-121, an investigational gene therapy for treatment of neuronopathic mucopolysaccharidosis type II (MPS II),' will be given by Dr. Roberto Giugliani on Wednesday, September 4, 2024, at 6:15 p.m. WEST. This presentation suggests ongoing progress in REGENXBIO's gene therapy research for MPS II.
REGENXBIO Inc. (Nasdaq: RGNX) has announced its participation in the H.C. Wainwright 4th Annual Ophthalmology Virtual Conference on Thursday, August 15, 2024. The company will be part of a panel discussion titled 'The Evolving Therapeutic Landscape of AMD' scheduled for 9:00 a.m. EDT.
Interested parties can access a live webcast of the panel through the Investors section of REGENXBIO's website at www.regenxbio.com. An archived replay will be available for approximately 30 days following the presentation, providing an opportunity for those unable to attend the live event to catch up on the discussion.