4D Molecular Therapeutics, Inc. - FDMT STOCK NEWS

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.

4D Molecular Therapeutics (FDMT) announced its third quarter 2022 financial results, reporting total revenue of $0.5 million, down from $1.4 million in Q3 2021. The net loss increased to $25.7 million from $22.2 million year-over-year. The company highlighted promising interim data from its Phase 1/2 clinical trial of 4D-710 for cystic fibrosis, showing safety and transgene expression in patients. With $239 million in cash and equivalents, FDMT expects to fund operations into the first half of 2025, emphasizing efficient cash utilization.

4D Molecular Therapeutics (Nasdaq: FDMT) announced positive interim results from the Phase 1/2 trial of 4D-710 for cystic fibrosis at the NACFC. All three patients in Cohort 1 exhibited 100% successful delivery and expression of the CFTR∆R transgene in lung tissue samples. The treatment was well tolerated with no drug-related adverse events reported. Ongoing enrollment for Cohort 2 is underway, and further data is expected in 2023, highlighting the potential of 4D-710 for patients not eligible for current CFTR modulators.

4D Molecular Therapeutics (Nasdaq: FDMT) will present interim clinical data from its Phase 1/2 trial of 4D-710 at the North American Cystic Fibrosis Conference (NACFC) from November 3-5, 2022. The presentation will cover safety, tolerability, delivery, and CFTR transgene expression in cystic fibrosis patients. Following the presentation, a conference call will be hosted on November 3rd at 4:30 PM ET to discuss results. 4D-710 aims to treat cystic fibrosis via aerosol delivery, potentially benefiting a wide range of patients with various CFTR mutations.