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) will present at the American Society of Gene & Cell Therapy (ASGCT) 25th Annual Meeting from May 16-19, 2022, in Washington, D.C. Key presentations include interim analyses of the RGX-121 and RGX-111 gene therapies for MPS II and MPS I, respectively, and insights on novel AAV vectors. Notable speakers include Nina Hunter, Ph.D., and Roberto Giugliani, M.D., among others. The event highlights REGENXBIO's capabilities in gene therapy, emphasizing its NAV Technology Platform with over 100 AAV vectors developed for various therapeutic areas.
REGENXBIO Inc. (Nasdaq: RGNX) will host a conference call on May 4, 2022, at 4:30 p.m. ET to discuss its financial results for Q1 2022 and operational highlights. Interested parties can access the call via phone or a live webcast on the company's website. REGENXBIO focuses on gene therapy, utilizing its proprietary NAV Technology Platform, which includes rights to over 100 novel AAV vectors applicable across various therapeutic areas.
REGENXBIO Inc. (Nasdaq: RGNX) announced its participation in a fireside chat at Chardan's 6th Annual Genetic Medicines and Cell Therapy Manufacturing Summit, scheduled for April 26, 2022, at 8:30 a.m. ET. The virtual conference will allow investors to access a webcast of the chat through REGENXBIO's website, with an archived version available for approximately 30 days afterward. The company focuses on gene therapy, leveraging its proprietary NAV Technology Platform, which includes over 100 novel AAV vectors, to develop treatments across various therapeutic areas.
REGENXBIO Inc. (RGNX) will participate in two investor conferences: the Barclays Global Healthcare Conference on March 17, 2022, at 11:15 a.m. ET in Miami, FL, and the Morgan Stanley Healthcare Corporate Access Day on March 29, 2022, in Boston, MA. A live webcast of the Barclays presentation will be available on the company's website, with an archived replay accessible for 30 days. REGENXBIO is a clinical-stage biotechnology firm focused on gene therapy, utilizing its NAV Technology Platform for a variety of therapeutic developments.
REGENXBIO announced a closed eye care collaboration agreement with AbbVie, receiving an upfront payment of $370 million and up to $1.38 billion in additional milestones. The company is advancing its RGX-314 program for wet AMD and diabetic retinopathy, with two pivotal trials ongoing. Positive six-month data from RGX-314 Phase II trials were presented. Additionally, RGX-202 received FDA clearance and designations, with a Phase I/II clinical trial set to begin in 2022. Financially, the company reported revenues of $398.7 million for Q4 2021 and a net income of $294 million.
REGENXBIO Inc. (Nasdaq: RGNX) will host a conference call on March 1, 2022, at 4:30 p.m. ET to discuss its financial results for Q4 and full-year 2021, along with recent operational highlights. Investors can join via phone or webcast, with the recorded version available for 30 days post-call. The company leverages its proprietary NAV® Technology Platform for gene therapy, holding exclusive rights to over 100 novel AAV vectors applicable in various therapeutic areas.
REGENXBIO Inc. (Nasdaq: RGNX) announced promising interim results from the Phase II ALTITUDE™ trial for RGX-314, aimed at treating diabetic retinopathy (DR). Presented at the Angiogenesis conference, data shows nearly 50% of patients in Cohort 1 achieved a significant improvement on the Diabetic Retinopathy Severity Scale after six months post-injection. The treatment was well tolerated with minimal adverse events. The trial continues to enroll patients in subsequent cohorts, suggesting positive potential for RGX-314 as a viable option for patients suffering from DR.
REGENXBIO presented positive interim data for RGX-111, a potential one-time gene therapy for MPS I, at the 18th Annual WORLD Symposium on Feb 9, 2022. RGX-111 showed good tolerability with no serious drug-related adverse events across two dosing cohorts. Biomarker and neurodevelopmental assessments revealed encouraging results, indicating biological activity in the CNS after treatment. The Phase I/II trial has expanded to enroll up to six additional patients. RGX-111 aims to address the limitations of current MPS I treatments, highlighting its potential in gene therapy.
REGENXBIO (Nasdaq: RGNX) reported positive interim results from the Phase I/II trial of RGX-121 for treating Mucopolysaccharidosis Type II (MPS II). The gene therapy was well-tolerated, showing no drug-related serious adverse events across 13 patients. Significant biomarker reductions were observed, particularly in CSF Heparan sulfate and D2S6 levels. Neurodevelopmental improvements continued for up to two years post-administration.
The expansion of Cohort 3 using commercial-scale cGMP material is planned for the first half of 2022.
REGENXBIO Inc. (Nasdaq: RGNX) announced its participation in a fireside chat at the 11th Annual SVB Leerink Global Healthcare Conference on February 16, 2022, at 8:40 a.m. ET. The event will be held virtually, and a webcast will be accessible on the company's website, with an archived replay available for 30 days post-event. REGENXBIO focuses on gene therapy, utilizing its proprietary NAV Technology Platform, which includes over 100 novel AAV vectors in developing a pipeline of therapeutic candidates.
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