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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 (RGNX) reports Q1 2022 financial results, highlighting a revenue increase to $22.2 million, primarily from Zolgensma royalties. The company has $765 million in cash, providing operational runway into 2025. Key developments include ongoing enrollment in pivotal trials for RGX-314 targeting wet AMD and diabetic retinopathy, and delayed initiation of the AFFINITY DUCHENNE trial. The in-house cGMP facility is now operational, enhancing manufacturing capacity. CEO Kenneth T. Mills expresses optimism about advancing five AAV Therapeutics into pivotal stages by 2025.
REGENXBIO Inc. (Nasdaq: RGNX) announced its participation in two upcoming investor conferences. The Bank of America Securities 2022 Healthcare Conference will take place on May 10, 2022, at the Encore Hotel in Las Vegas, with a presentation scheduled for 4:00 p.m. PT. The UBS Global Healthcare Conference 2022 is set for May 24, 2022, at Lotte New York Palace, with a presentation at 10:45 a.m. ET. Webcasts of both events will be available on the REGENXBIO website for approximately 30 days following their presentations.
REGENXBIO Inc. (Nasdaq: RGNX) will present at the American Society of Gene & Cell Therapy (ASGCT) 25th Annual Meeting from May 16-19, 2022, in Washington, D.C. Key presentations include interim analyses of the RGX-121 and RGX-111 gene therapies for MPS II and MPS I, respectively, and insights on novel AAV vectors. Notable speakers include Nina Hunter, Ph.D., and Roberto Giugliani, M.D., among others. The event highlights REGENXBIO's capabilities in gene therapy, emphasizing its NAV Technology Platform with over 100 AAV vectors developed for various therapeutic areas.
REGENXBIO Inc. (Nasdaq: RGNX) will host a conference call on May 4, 2022, at 4:30 p.m. ET to discuss its financial results for Q1 2022 and operational highlights. Interested parties can access the call via phone or a live webcast on the company's website. REGENXBIO focuses on gene therapy, utilizing its proprietary NAV Technology Platform, which includes rights to over 100 novel AAV vectors applicable across various therapeutic areas.
REGENXBIO Inc. (Nasdaq: RGNX) announced its participation in a fireside chat at Chardan's 6th Annual Genetic Medicines and Cell Therapy Manufacturing Summit, scheduled for April 26, 2022, at 8:30 a.m. ET. The virtual conference will allow investors to access a webcast of the chat through REGENXBIO's website, with an archived version available for approximately 30 days afterward. The company focuses on gene therapy, leveraging its proprietary NAV Technology Platform, which includes over 100 novel AAV vectors, to develop treatments across various therapeutic areas.
REGENXBIO Inc. (RGNX) will participate in two investor conferences: the Barclays Global Healthcare Conference on March 17, 2022, at 11:15 a.m. ET in Miami, FL, and the Morgan Stanley Healthcare Corporate Access Day on March 29, 2022, in Boston, MA. A live webcast of the Barclays presentation will be available on the company's website, with an archived replay accessible for 30 days. REGENXBIO is a clinical-stage biotechnology firm focused on gene therapy, utilizing its NAV Technology Platform for a variety of therapeutic developments.
REGENXBIO announced a closed eye care collaboration agreement with AbbVie, receiving an upfront payment of $370 million and up to $1.38 billion in additional milestones. The company is advancing its RGX-314 program for wet AMD and diabetic retinopathy, with two pivotal trials ongoing. Positive six-month data from RGX-314 Phase II trials were presented. Additionally, RGX-202 received FDA clearance and designations, with a Phase I/II clinical trial set to begin in 2022. Financially, the company reported revenues of $398.7 million for Q4 2021 and a net income of $294 million.
REGENXBIO Inc. (Nasdaq: RGNX) will host a conference call on March 1, 2022, at 4:30 p.m. ET to discuss its financial results for Q4 and full-year 2021, along with recent operational highlights. Investors can join via phone or webcast, with the recorded version available for 30 days post-call. The company leverages its proprietary NAV® Technology Platform for gene therapy, holding exclusive rights to over 100 novel AAV vectors applicable in various therapeutic areas.
REGENXBIO Inc. (Nasdaq: RGNX) announced promising interim results from the Phase II ALTITUDE™ trial for RGX-314, aimed at treating diabetic retinopathy (DR). Presented at the Angiogenesis conference, data shows nearly 50% of patients in Cohort 1 achieved a significant improvement on the Diabetic Retinopathy Severity Scale after six months post-injection. The treatment was well tolerated with minimal adverse events. The trial continues to enroll patients in subsequent cohorts, suggesting positive potential for RGX-314 as a viable option for patients suffering from DR.
REGENXBIO presented positive interim data for RGX-111, a potential one-time gene therapy for MPS I, at the 18th Annual WORLD Symposium on Feb 9, 2022. RGX-111 showed good tolerability with no serious drug-related adverse events across two dosing cohorts. Biomarker and neurodevelopmental assessments revealed encouraging results, indicating biological activity in the CNS after treatment. The Phase I/II trial has expanded to enroll up to six additional patients. RGX-111 aims to address the limitations of current MPS I treatments, highlighting its potential in gene therapy.
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