4D Molecular Therapeutics Inc. Stock Price, News & Analysis

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.