Welcome to our dedicated page for 4D Molecular Therapeutics news (Ticker: FDMT), a resource for investors and traders seeking the latest updates and insights on 4D Molecular Therapeutics stock.
4D Molecular Therapeutics, Inc. (Nasdaq: FDMT) is a late-stage biotechnology company developing durable, disease-targeted genetic medicines. News about 4D Molecular Therapeutics often focuses on progress in its lead programs, 4D-150 for retinal vascular diseases and 4D-710 for cystic fibrosis lung disease, as well as corporate, financial and partnership developments.
For ophthalmology, company updates highlight clinical data and milestones for 4D-150 in wet age-related macular degeneration and diabetic macular edema. These include interim results from the PRISM Phase 1/2 trial, enrollment and design details for the 4FRONT Phase 3 program, and plans for global Phase 3 trials in DME. News items also cover collaborations, such as the license and development agreement with Otsuka Pharmaceutical for 4D-150 in Asia-Pacific markets.
In pulmonology, 4DMT news includes interim clinical data from the AEROW Phase 1/2 trial of 4D-710 in cystic fibrosis lung disease, describing CFTR transgene expression, lung function measures and dose selection for Phase 2. Additional coverage addresses external support, including an equity investment from the Cystic Fibrosis Foundation to help advance 4D-710.
Investors can also find announcements on equity offerings, cash runway guidance, leadership changes, board appointments, employment inducement grants and participation in healthcare and investor conferences. This news page aggregates these updates so readers can follow clinical progress, strategic partnerships, capital markets activity and governance developments related to FDMT over time.
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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.
4D Molecular Therapeutics (Nasdaq: FDMT) has announced promising interim results from its Phase 1/2 trials for 4D-310 aimed at treating Fabry disease cardiomyopathy. All three patients showed improvements in FDA-recommended cardiac endpoints after 12 months of treatment at a low dose of 1E13 vg/kg. Cardiac biopsies revealed selective transgene expression in approximately 50% of cardiomyocytes. The treatment was generally well tolerated, with a transient acute adverse event (aHUS). The company is engaging with the FDA to lift the clinical hold and plans to update exclusion criteria and implement a new immunosuppressive regimen to mitigate safety risks.
4D Molecular Therapeutics (Nasdaq: FDMT) has announced a live webcast on February 22, 2023, to present interim clinical data from its Phase 1/2 trial of 4D-310 INGLAXA, aimed at treating Fabry disease cardiomyopathy. The presentation will include 12-month cardiac safety and efficacy data, including an analysis of a cardiac biopsy.
Additionally, 4DMT will present cardiac efficacy data at the 19th annual WORLD Symposium™ on February 25, 2023. Fabry disease affects over 50,000 individuals in the US and EU, leading to severe health issues like cardiac complications, necessitating innovative treatments like 4D-310.
4D Molecular Therapeutics (Nasdaq: FDMT) announced its participation in the SVB Securities Global Biopharma Conference on February 15, 2023, at 4:20 p.m. EST. CEO David Kirn, M.D., will engage in a virtual fireside chat, with management available for one-on-one meetings. Interested individuals can access the live webcast here. 4DMT focuses on innovating targeted genetic medicines in areas such as ophthalmology, pulmonology, and cardiology.
4D Molecular Therapeutics (Nasdaq: FDMT) announced FDA clearance for its Investigational New Drug Application (IND) for 4D-150, a genetic medicine targeting Diabetic Macular Edema (DME). The Phase 2 SPECTRA trial, set to start in Q3 2023, will evaluate 4D-150's effectiveness compared to aflibercept in 54 patients. Initial data from a related Phase 1/2 PRISM trial for wet age-related macular degeneration (wet AMD) has shown over a 95% reduction in anti-VEGF injection rates. 4DMT has successfully cleared all six US IND applications submitted to the FDA, highlighting its robust clinical development capabilities.