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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 that data from its RGX-314 clinical trials will be presented at the American Academy of Ophthalmology 2021 Annual Meeting in New Orleans, LA, from November 12-15, 2021. RGX-314, a potential one-time gene therapy targeting wet age-related macular degeneration and diabetic retinopathy, will be showcased in an oral presentation by Dr. Robert L. Avery on November 12. The therapy utilizes the NAV AAV8 vector to inhibit VEGF, potentially preventing fluid accumulation in the retina.
REGENXBIO and AbbVie announced a strategic collaboration to develop RGX-314, focusing on wet AMD and diabetic retinopathy, with REGENXBIO receiving a $370 million upfront payment. The partnership aims to leverage both companies' expertise for potential milestone payments totaling $1.38 billion. Positive Phase II trial data for RGX-314 showed stable visual acuity and reduced treatment burden. Financially, REGENXBIO reported $30.8 million in Q3 revenues, down from $98.9 million the same period in 2020, and a net loss of $58.4 million. Cash reserves were $533.5 million as of September 30, 2021.
REGENXBIO Inc. (Nasdaq: RGNX) announced a conference call scheduled for November 2, 2021, at 4:30 p.m. ET. The call will cover the company's financial results for the quarter ended September 30, 2021, and recent operational highlights. Investors can access the call via phone or a webcast on the REGENXBIO website. The company is focused on gene therapy through its NAV® Technology Platform, which includes over 100 exclusive AAV vectors aimed at various therapeutic areas.
REGENXBIO announced positive interim data from the Phase II ALTITUDE trial of RGX-314, a gene therapy for diabetic retinopathy (DR). In Cohort 1, 33% of patients showed a two-step improvement in DR severity after three months, compared to none in the control group. The treatment was well-tolerated with no serious drug-related adverse events. Cohorts 2 and 3 are ongoing at a higher dose of 5x1011 GC/eye. This therapy could significantly benefit the approximately eight million people affected by DR in the U.S.
REGENXBIO (Nasdaq: RGNX) announced positive initial data from the Phase II AAVIATE trial of RGX-314 for wet AMD treatment via suprachoroidal delivery. In Cohort 1, 14 patients showed stable visual acuity and retinal thickness at six months, with a 75.9% reduction in anti-VEGF injections. No drug-related serious adverse events were reported among 50 patients in Cohorts 1-3. The trial is expanding to include a third dose level of RGX-314. A conference call featuring key opinion leaders will provide further insights.
REGENXBIO announced that data from its RGX-314 clinical trials will be presented at the American Society of Retina Specialists Annual Meeting in San Antonio, TX, from October 8-12, 2021. The presentations will focus on interim results from the Phase II ALTITUDE trial, which evaluates RGX-314 for diabetic retinopathy. Key presentations include early results from Cohort 1 on October 9 and additional studies on neovascular AMD on October 11.
REGENXBIO Inc. (Nasdaq: RGNX) announced the presentation of interim data for the RGX-314 Phase II trial targeting wet age-related macular degeneration (AMD) at the Retina Society 54th Annual Scientific Meeting from September 29 to October 2, 2021. The data from Cohort 1 will be discussed during two oral presentations on October 1, featuring experts in ophthalmology. This investigational gene therapy aims for a one-time treatment to inhibit VEGF and reduce fluid accumulation in the retina. A conference call is scheduled for the same day to review the findings.
AbbVie and REGENXBIO announced a partnership to develop RGX-314, a gene therapy for wet age-related macular degeneration (AMD) and diabetic retinopathy (DR). REGENXBIO will complete ongoing trials, while AbbVie leads global development and commercialization. AbbVie will pay REGENXBIO $370 million upfront, with potential total payments of up to $1.38 billion based on milestones. They will share profits from U.S. sales equally, with AbbVie paying tiered royalties internationally. The deal is expected to close by the end of 2021, contingent on regulatory approvals.
REGENXBIO Inc. (Nasdaq: RGNX) announced its participation in upcoming virtual investor conferences. Key events include a fireside chat at the Morgan Stanley 19th Annual Global Healthcare Conference on September 14, 2021, and another at Chardan's 5th Annual Genetic Medicines Conference on October 5, 2021. Webcasts for these chats will be available on the company's website for 90 days post-event. REGENXBIO specializes in gene therapy utilizing its proprietary NAV Technology Platform, which includes over 100 AAV vectors aimed at various therapeutic applications.
REGENXBIO Inc. (Nasdaq: RGNX) has appointed Dr. Jean Bennett and Mr. George Migausky to its Board of Directors, effective September 3, 2021. Dr. Bennett is known for her expertise in gene therapy and has contributed significantly to the field, including the development of Luxturna®. Mr. Migausky brings over 30 years of financial and operational leadership experience. The appointments come as REGENXBIO advances its clinical programs, particularly RGX-314 for wet age-related macular degeneration. The company also announced the resignation of Luke M. Beshar from the board.
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