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REGENXBIO Inc. (RGNX) will host a conference call to discuss its Q4 and full-year 2023 financial results and recent operational highlights on February 27, 2024.
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REGENXBIO Inc. (RGNX) announced topline results from the Phase I/II/III CAMPSIITE® trial of RGX-121, a treatment for Mucopolysaccharidosis Type II (MPS II) or Hunter syndrome. The trial met its primary endpoint with statistical significance, supporting the BLA submission in 2024 using the accelerated approval pathway. Patients treated with RGX-121 showed continued improvement in neurodevelopmental skill acquisition up to four years, and the company plans to discuss these results as part of a full rare disease program update on its conference call.
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REGENXBIO Inc. (Nasdaq: RGNX) has completed enrollment in cohort 2 of the Phase I/II AFFINITY DUCHENNE trial of RGX-202, demonstrating strong microdystrophin expression across a wide range of patients. The third patient at dose level 1 showed the largest increase in microdystrophin expression at 83.4% of control. The company is on track to initiate a pivotal trial in the second half of 2024 and plans to discuss the new results in a conference call. Enrollment has been completed at dose level 2, and RGX-202 has been well tolerated with no drug-related serious adverse events in five patients. The company expects to make a pivotal dose determination in mid-2024 and share initial strength and functional assessment data for both dose levels. The Phase I/II AFFINITY DUCHENNE trial is a multicenter, open-label dose escalation and dose expansion clinical study to evaluate the safety, tolerability, and clinical efficacy of a one-time intravenous dose of RGX-202 in patients with Duchenne.
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REGENXBIO Inc. announced presentations on its program for the treatment of mucopolysaccharidosis type II (MPS II), also known as Hunter syndrome, at the 20th Annual WORLDSymposium™ 2024. The topline results from the pivotal phase of the Phase I/II/III CAMPSIITE® trial of RGX-121 for the treatment of MPS II will be presented. The company will also discuss intracisternal administration of investigational AAV9 gene therapies to target the central nervous system in pediatric lysosomal disorders. A conference call will be held to discuss the CAMPSIITE trial pivotal phase topline results and the expedited plan for filing a Biologics License Application using the accelerated approval pathway in 2024.
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REGENXBIO Inc. announced positive interim data from the Phase II AAVIATE trial of ABBV-RGX-314 for the treatment of wet age-related macular degeneration (wet AMD) using suprachoroidal delivery. The treatment demonstrated the potential to sustain constant anti-VEGF therapy and stabilize or improve vision long-term. The data showed that ABBV-RGX-314 was well tolerated in over 100 patients, with no drug-related serious adverse events. The treatment also resulted in an 80% reduction in annualized injection rate and 50% of patients remaining injection-free.
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REGENXBIO Inc. (Nasdaq: RGNX) will present data from the Phase II AAVIATE® trial of suprachoroidal ABBV-RGX-314 for the treatment of wet age-related macular degeneration (AMD) at the Hawaiian Eye and Retina 2024 Meeting. ABBV-RGX-314 is an investigational one-time AAV Therapeutic developed in collaboration with AbbVie for the treatment of wet AMD, diabetic retinopathy, and other chronic retinal conditions.
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REGENXBIO Inc. (RGNX) faces a setback as the U.S. District Court for the District of Delaware granted Sarepta Therapeutics, Inc. summary judgment on invalidity in a patent infringement suit. The lawsuit concerns Sarepta's use of cultured host cell technology covered by a University of Pennsylvania patent to make clinical and commercial supplies of SRP-9001 for the treatment of Duchenne muscular dystrophy. REGENXBIO intends to file an immediate appeal. The ruling does not impact REGENXBIO's current licenses or therapeutic pipeline.
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REGENXBIO Inc. (Nasdaq: RGNX) announced the first patient received dose level 2 of RGX-202, a potential one-time AAV Therapeutic for Duchenne muscular dystrophy. The Phase I/II AFFINITY DUCHENNE trial is on track for pivotal dose determination and initiation of pivotal program in 2024. Initial biomarker data and preclinical efficacy studies show promising results for RGX-202, supporting its potential to be a best-in-class product.
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REGENXBIO Inc. (Nasdaq: RGNX) announces pipeline prioritization and corporate restructuring to focus on clinical stage AAV Therapeutic product candidates. Highest priority programs include ABBV-RGX-314 for wet AMD and diabetic retinopathy, RGX-202 for Duchenne, and RGX-121 for MPS II. Restructuring plan includes a 15% reduction in workforce, expected to save at least $100 million. Anticipated cost savings, along with $365 million in cash, expected to fund operational runway into the second half of 2025. Conference call on Wednesday, November 8, 2023, at 4:30 p.m. (EST)
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REGENXBIO Inc. (RGNX) will participate in two upcoming investor conferences: the Stifel 2023 Healthcare Conference on November 14, 2023, and the Piper Sandler 35th Annual Healthcare Conference on November 29, 2023, both in New York, NY. The fireside chats will be live webcasted and available for replay on the company's website.
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REGENXBIO Inc.
Nasdaq:RGNX
RGNX Rankings
RGNX Stock Data
825.39M
37.36M
7.18%
81.62%
8.05%
Biological Product (except Diagnostic) Manufacturing
Manufacturing
United States of America
ROCKVILLE
About RGNX
regenxbio is a leading biotechnology company focused on the development, commercialization and licensing of recombinant adeno‐associated virus (aav) gene therapy. regenxbio's nav® technology platform, a proprietary aav gene delivery platform, consists of exclusive rights to more than 100 novel aav vectors, including aav7, aav8, aav9 and aavrh10. regenxbio's mission is to transform the lives of patients suffering from severe diseases with significant unmet medical need by developing and commercializing in vivo gene therapy products based on regenxbio's nav technology platform. regenxbio seeks to accomplish this mission through a combination of internal development efforts and third‐party nav technology platform licensees.