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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 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.
REGENXBIO (RGNX) reported $22 million in Q2 2021 revenue, up from $16.6 million in Q2 2020, driven by a $6.5 million increase in Zolgensma royalties. The company holds $593 million in cash as of June 30, 2021, positioning it well to fund operations through mid-2023. Ongoing clinical trials for RGX-314 and RGX-121 show promise, with interim data set for presentation at the Retina Society meeting. Meanwhile, the net loss rose to $57.6 million, reflecting increased R&D and G&A expenses. The firm aims to submit an IND for RGX-202 by year-end 2021.
REGENXBIO Inc. (Nasdaq: RGNX) will host a conference call on August 9, 2021, at 4:30 p.m. ET to discuss its Q2 2021 financial results and operational highlights. Interested participants can join the call by dialing (855) 422-8964 or accessing the webcast on the company's website. REGENXBIO focuses on gene therapy using its proprietary NAV® Technology Platform, which includes over 100 adeno-associated viral vectors. The company aims to develop a robust pipeline across various therapeutic areas.
REGENXBIO Inc. (Nasdaq: RGNX) announced its participation in two upcoming virtual investor conferences in June 2021. The Bank of America 2021 Napa Biopharma Virtual Conference will feature a fireside chat on June 16, 2021, at 12:30 p.m. E.T. Additionally, the Raymond James Human Health Innovation Conference is scheduled for June 21, 2021. Investors can access the live webcast of the Bank of America event on REGENXBIO's website, with an archived replay available for 30 days thereafter. REGENXBIO focuses on gene therapy through its proprietary NAV Technology Platform.
REGENXBIO has announced positive interim data from the ongoing Phase I/II trial of RGX-121, a gene therapy for Mucopolysaccharidosis Type II (MPS II). Key findings include no serious drug-related adverse events and evidence of CNS activity in patients up to two years post-administration. Biomarkers indicate strong I2S enzyme activity, and most patients showed continued neurocognitive development. The company has initiated dosing in Cohort 3 at an increased dosage, further enhancing prospects for RGX-121 as a treatment option for MPS II.
REGENXBIO Inc. (Nasdaq: RGNX) will present at three upcoming virtual investor conferences in May 2021. The events include:
- Bank of America Securities 2021 Virtual Health Care Conference on May 12, 2021, at 12:30 p.m. E.T.
- RBC Capital Markets 2021 Global Healthcare Virtual Conference on May 18, 2021, at 10:55 a.m. E.T.
- UBS Global Healthcare Virtual Conference on May 25, 2021, at 11:00 a.m. E.T.
Live webcasts will be accessible on the REGENXBIO website, with replays available for 30 days.
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