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REGENXBIO Inc. (Nasdaq: RGNX) is a pioneering biotechnology company dedicated to transforming patient lives through the development and commercialization of innovative gene therapies. The company's core focus lies in the use of recombinant adeno-associated virus (AAV) gene therapy, leveraging its proprietary NAV® Technology Platform. This platform includes exclusive rights to over 100 novel AAV vectors, such as AAV7, AAV8, AAV9, and AAVrh10, which are crucial for delivering therapeutic genes. REGENXBIO aims to address serious diseases with significant unmet medical needs through both in-house development and third-party licensing agreements.
REGENXBIO's mission is realized through its robust pipeline, which targets various challenging conditions:
- Metabolic Diseases: The company is working on therapies for homozygous familial hypercholesterolemia.
- Neurodegenerative Conditions: Their efforts include treatments for mucopolysaccharidosis (MPS), specifically Type II (Hunter syndrome).
- Retinal Diseases: Projects include therapies for wet age-related macular degeneration (wet AMD) and X-linked retinitis pigmentosa.
REGENXBIO has several high-profile partnerships. Collaborations with AbbVie are advancing ABBV-RGX-314, a potential one-time treatment for wet AMD and diabetic retinopathy. They also have licensed their technology to renowned firms like Novartis and Eli Lilly, which are using it to develop therapies for spinal muscular atrophy and various neurodegenerative diseases, respectively.
Recent Achievements and Financial Highlights:
- Completion of enrollment at dose level 2 in the Phase I/II AFFINITY DUCHENNE® trial for RGX-202, aimed at treating Duchenne muscular dystrophy.
- Topline results from the CAMPSIITE® trial for RGX-121, targeting MPS II, showing significant improvement in brain function biomarkers.
- Publication of ABBV-RGX-314 trial results in The Lancet, demonstrating long-term efficacy for wet AMD.
Financial Condition: As of March 31, 2024, REGENXBIO has a strong cash position, with $380.5 million in cash, cash equivalents, and marketable securities. Despite a net loss of $63.3 million for Q1 2024, the company expects its cash reserves to fund operations into 2026, bolstered by proceeds from a recent public offering and potential milestone payments from partners.
REGENXBIO continues to make significant strides in its
REGENXBIO Inc. (Nasdaq: RGNX) announced its participation in the Angiogenesis, Exudation, and Degeneration 2021 conference on February 12-13, 2021. Two oral presentations will showcase advancements in gene therapy for eye diseases:
- Subretinal Gene Therapy for Exudative AMD by Allen C. Ho, M.D. on February 13 at 9:15 a.m. ET
- Suprachoroidal Gene Therapy for Exudative AMD and Diabetic Retinopathy by Peter A. Campochiaro, M.D. on February 13 at 9:45 a.m. ET
These presentations highlight the company's innovative approaches using its NAV® Technology Platform.
REGENXBIO Inc. (Nasdaq: RGNX) has announced three oral and nine poster presentations for the 17th Annual WORLD Symposium™ from February 8-12, 2021. Key presentations include interim results from the Phase I/II trial of RGX-121 targeting mucopolysaccharidosis type II (MPS II). Notable presentations cover comparative effectiveness of gene therapies and clinical updates on RGX-121. REGENXBIO is focused on advancing its NAV Technology Platform for gene therapy applications, with exclusive rights to over 100 AAV vectors.
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.
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