4D Molecular Therapeutics, Inc. - FDMT STOCK NEWS

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.

4D Molecular Therapeutics (Nasdaq: FDMT) announced the expansion of its ophthalmology and pulmonology portfolios following positive clinical data in wet AMD and cystic fibrosis. The company filed an IND for a Phase 2 trial of 4D-150 in Diabetic Macular Edema and initiated a Phase 2 trial for wet AMD. A new preclinical candidate for Geographic Atrophy was also introduced. The interim results of the 4D-310 Fabry disease trial indicated promising cardiac endpoint improvements, with full data expected at the WORLDSymposium in February 2023. Cash guidance remains stable, funding operations through H1 2025.

4D Molecular Therapeutics (Nasdaq: FDMT) announced promising interim data from cohort 1 of their Phase 1/2 clinical trial of 4D-150 for wet AMD, showcasing a 96.7% reduction in the annualized anti-VEGF injection rate. The trial involved 5 patients who had a high pre-treatment injection rate. Notably, 80% of these patients remained injection-free for up to 10 months post-treatment, with no significant safety concerns reported. The company plans to move into randomized Phase 2 enrollment in Q1 2023, further validating the potential of their innovative gene therapy.

4D Molecular Therapeutics (Nasdaq: FDMT) has completed enrollment in all three cohorts of its Phase 1 Dose Exploration clinical trial for 4D-150 in patients with wet AMD, totaling 15 patients. All cohorts reported no dose-limiting toxicities, indicating safety. Interim clinical data from cohort 1 will be released on November 14, 2022, at 7:30 am E.T., followed by a conference call at 8:00 am E.T. The data will cover safety, efficacy, and aflibercept transgene expression. This investigational treatment aims to manage wet AMD, a condition leading to vision loss.