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4D Molecular Therapeutics, Inc. (Nasdaq: FDMT) is a clinical-stage gene therapy company dedicated to developing transformative medicines for serious, unmet medical conditions. Utilizing its proprietary Therapeutic Vector Evolution platform, the company designs novel adeno-associated virus (AAV) vectors to treat genetic diseases.
Core Business: 4DMT focuses on three primary therapeutic areas: Ophthalmology, Cardiology, and Pulmonology. In ophthalmology, intravitreal vectors are employed for treatments like 4D-150 for wet age-related macular degeneration (wet AMD) and diabetic macular edema (DME). Cardiology projects include 4D-310 for Fabry disease cardiomyopathy, while pulmonology efforts are highlighted by 4D-710 for cystic fibrosis.
Recent Achievements: The company has shown promising interim safety and efficacy data for 4D-310 in treating Fabry disease cardiomyopathy, with significant improvements in cardiac function, exercise capacity, and quality of life. For 4D-150, positive interim results from the PRISM clinical trial indicate its potential as a best-in-class treatment for wet AMD, leading to the initiation of a Phase 3 clinical trial in 2025.
Partnerships and Financial Condition: 4DMT has established strategic partnerships and recently secured substantial financing, bolstering its financial health. The company reported $589 million in cash equivalents by Q1 2024, sufficient to fund operations into the first half of 2027.
Innovative Pipeline: 4DMT’s product candidates, currently in clinical and preclinical stages, include 4D-175 for geographic atrophy, 4D-725 for A1AT deficiency, and additional CNS programs through gene editing partnerships. The company’s advanced manufacturing processes support the potential commercialization of these therapies.
Learn more at www.4DMT.com and follow on LinkedIn.
4D Molecular Therapeutics (Nasdaq: FDMT) announced interim clinical results from its Phase 1/2 PRISM trial of 4D-150 for wet age-related macular degeneration (AMD). The treatment was well-tolerated, with no severe side effects across 15 patients. Key findings include:
- 80% of patients in the high-dose cohort (3E10 vg/eye) did not require additional anti-VEGF injections at 36 weeks.
- Clinically meaningful reduction in mean central subfield thickness (CST) of -92 µm after treatment.
- No inflammation or serious adverse events reported.
The trial’s Phase 2 Dose Expansion stage is over 50% enrolled, with expected completion in Q3 2023. 4DMT aims to advance this therapy into late-stage development swiftly, which may significantly impact the treatment landscape for wet AMD.
4D Molecular Therapeutics (Nasdaq: FDMT) has acquired worldwide rights to short-form human complement factor H (sCFH) from Aevitas Therapeutics. This innovative technology, developed at the University of Pennsylvania, will be incorporated into 4D-175, a product candidate targeting geographic atrophy (GA) secondary to age-related macular degeneration (AMD).
Approximately 75% of AMD patients have high-risk CFH variants, underscoring the potential market for 4D-175. Geographic atrophy affects over one million individuals in the U.S., presenting a significant unmet medical need. The sCFH is engineered to provide sustained therapeutic expression from a single injection, potentially improving treatment adherence and outcomes.
4D Molecular Therapeutics (FDMT) has announced the oral presentation of interim data from its 4D-150 Phase 1/2 PRISM clinical trial for wet age-related macular degeneration (wet AMD) at the 2023 ARVO Annual Meeting on April 27, 2023. The trial involves a low-dose intravitreal delivery system that targets multiple angiogenic factors. The interim results, to be presented by Dr. Arshad M. Khanani, include data from three dose cohorts and a total of 15 patients. Additionally, 4DMT has promoted Dr. Robert Kim to Chief Medical Officer, aiming to enhance its genetic medicine pipeline targeting large market ophthalmologic diseases. A live webcast detailing the trial data and program updates is scheduled for the same day.
4D Molecular Therapeutics (Nasdaq: FDMT) announced its full-year 2022 financial results, reporting a net loss of $107.5 million, up from $71.3 million in 2021. Total revenue fell to $3.1 million from $18.0 million, mainly due to the termination of a collaboration agreement. The company expanded its clinical pipeline with updates on lead candidates, including 4D-150 for wet age-related macular degeneration and 4D-710 for cystic fibrosis. Positive clinical data and cash reserves of $218.5 million are expected to fund operations through the first half of 2025. Key milestones projected for 2023 include multiple clinical data updates.
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