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) has successfully closed its public offering of 4,260,000 common stock shares at $47.00 each, yielding approximately $230.3 million in gross proceeds after the underwriters' full option exercise for an additional 639,000 shares. This offering was managed by BofA Securities, Morgan Stanley, and Barclays. The shares were offered under a shelf registration statement effective since August 8, 2018. The funds raised will support REGENXBIO's ongoing gene therapy developments utilizing its proprietary NAV Technology Platform.
REGENXBIO Inc. (Nasdaq: RGNX) announced its presentation at the 39th Annual J.P. Morgan Healthcare Conference on January 14, 2021, at 11:40 a.m. ET. This virtual conference will showcase the company's advancements in gene therapy. A webcast will be available on REGENXBIO's website, with an archived replay accessible for 30 days. The company utilizes its proprietary NAV Technology Platform to develop innovative gene delivery systems across multiple therapeutic areas.
REGENXBIO Inc. (Nasdaq: RGNX) has priced a public offering of 4,260,000 shares of common stock at $47.00 per share. The offering is expected to generate approximately $200.2 million in gross proceeds before deductions. Closing is anticipated on January 12, 2021, subject to customary conditions. An additional 639,000 shares may be purchased by underwriters within 30 days. This offering is conducted under a shelf registration statement with the SEC, aiming to support REGENXBIO's ongoing gene therapy initiatives.
REGENXBIO Inc. (Nasdaq:RGNX) announced a proposed underwritten public offering of $175 million in common stock, subject to market conditions. The offering may include an additional 15% of shares at the underwriters' option. BofA Securities, Morgan Stanley, and Barclays are managing the offering. This action follows a shelf registration statement filed with the SEC in August 2018. The funds raised will likely support REGENXBIO's gene therapy initiatives based on its proprietary NAV® Technology Platform, which includes over 100 novel AAV vectors.
REGENXBIO Inc. (Nasdaq: RGNX) has announced a significant advancement in its gene therapy programs. The pivotal program for RGX-314, aimed at treating wet age-related macular degeneration (wet AMD), is active with ongoing patient screening. Two randomized trials will enroll approximately 700 patients, targeting a Biologics License Application (BLA) submission in 2024. Additionally, REGENXBIO introduced RGX-202, a promising one-time gene therapy for Duchenne Muscular Dystrophy (DMD), with plans to submit an Investigational New Drug (IND) application in mid-2021.
REGENXBIO Inc. (Nasdaq: RGNX) announced an agreement to sell a portion of its royalty rights from Novartis Gene Therapies' Zolgensma for $200 million. This transaction provides non-dilutive capital to enhance REGENXBIO's gene therapy pipeline and internal manufacturing capabilities. The agreement includes an upfront payment with future royalty potential, capped at 1.3 times the purchase price until November 2024. Zolgensma is approved in multiple countries for Spinal Muscular Atrophy (SMA) treatment, marking a significant milestone in gene therapy.
REGENXBIO (Nasdaq: RGNX) announced that the first patient has been dosed in its ALTITUDE Phase II trial for RGX-314, aimed at treating diabetic retinopathy (DR) via suprachoroidal delivery. This trial evaluates RGX-314's efficacy and safety, potentially providing a one-time treatment option to replace frequent anti-VEGF injections. The study plans to enroll about 40 patients, comparing RGX-314 with an observational control. Initial data is expected in 2021. DR, a leading cause of vision loss in adults, affects approximately 8 million in the U.S.
REGENXBIO Inc. (Nasdaq: RGNX) reported positive interim data from Cohorts 1 and 2 of its Phase I/II trial for RGX-121, a gene therapy targeting Mucopolysaccharidosis Type II (MPS II) in patients up to 5 years old. As of November 13, 2020, RGX-121 showed a good safety profile with no serious adverse events in 8 patients. Notable reductions in heparan sulfate levels in CSF were observed, and neurocognitive development continued in Cohort 1 patients. REGENXBIO plans to initiate Cohort 3 with a higher dose in Q1 2021, with more data to be presented at the WORLD Symposium in early 2021.
REGENXBIO (Nasdaq: RGNX) announced the dosing of the first patient in the Phase I/II trial for RGX-111, targeting Mucopolysaccharidosis Type I (MPS I). This investigational gene therapy aims to deliver the IDUA gene to the central nervous system using the NAV AAV9 vector. MPS I is a rare genetic disorder affecting 1 in 100,000 births, leading to severe neurological symptoms. The trial, focused on safety and pharmacodynamics, will enroll up to five patients, marking a significant step in REGENXBIO's commitment to treating rare diseases, following its previous candidate RGX-121.
REGENXBIO Inc. (Nasdaq: RGNX) announced participation in two upcoming virtual investor conferences in December 2020. The company will host a pre-recorded fireside chat at the Piper Sandler 32nd Annual Virtual Healthcare Conference and a live webcast at the Evercore ISI 3rd Annual HealthCONx Conference on December 3, 2020, at 11:45 a.m. ET. The pre-recorded chat is now available on REGENXBIO's website for 30 days. REGENXBIO focuses on gene therapy through its proprietary NAV Technology Platform, featuring over 100 AAV vectors for various therapeutic applications.