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), 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.
REGENXBIO Inc. (Nasdaq: RGNX) reported its Q2 2020 financial results, noting significant advancements in its gene therapy programs amid the COVID-19 pandemic. Key highlights include plans to launch a pivotal program for RGX-314 in treating wet AMD by year-end, and the completion of patient dosing for RGX-121 targeting MPS II. Revenues surged to $16.6 million, attributed mainly to increased royalties from Zolgensma sales. However, the company incurred a net loss of $33.8 million. Cash reserves stood at $339.2 million, expected to fund development into 2022.
On August 4, 2020, REGENXBIO announced positive updates for RGX-314, a potential one-time treatment for wet AMD, following the Phase I/IIa trial results. The data showed RGX-314 was well-tolerated in 42 patients, with a significant reduction in anti-VEGF injections—61% and 85% in Cohorts 4 and 5, respectively. The pivotal program for subretinal delivery is set to begin by year-end 2020. Additionally, a Phase II trial (AAVIATE) utilizing suprachoroidal delivery is expected to enroll patients in Q3 2020. Interim data from the AAVIATE trial will be reported by late 2020.
REGENXBIO Inc. (Nasdaq: RGNX), a biotechnology firm focused on gene therapy, will host a conference call on August 6, 2020, at 4:30 p.m. ET, to discuss its financial results for Q2 2020, ending June 30, 2020.
The call will provide insights into the company's operational highlights and financial performance. Investors can participate by calling (800) 708-4539 (domestic) or (800) 619-6396 (international), or by accessing a live or recorded webcast on the REGENXBIO website.
REGENXBIO (Nasdaq: RGNX) announced on July 8, 2020, the completion of dosing three patients in Cohort 2 of its Phase I/II study of RGX-121 for Mucopolysaccharidosis Type II (MPS II). The data reported shows RGX-121 to be well-tolerated with no serious adverse events. The company also provided initial data on RGX-111 for MPS I, showing positive biochemistry results and sustained cognitive development in a patient treated. Both RGX-121 and RGX-111 are designed to improve outcomes in patients with rare genetic disorders, and further data updates are expected later this year.