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4D Molecular Therapeutics has reached an agreement with the FDA to lift the clinical hold on the Phase 1/2 INGLAXA clinical trial for 4D-310, a treatment for Fabry disease cardiomyopathy. The company has shared the most up-to-date clinical activity and safety data with the FDA and plans to submit the results of a non-clinical study evaluating the safety and biodistribution of 4D-310 to the FDA in Q2 2024. The INGLAXA trial protocol has been amended to minimize the risk of atypical hemolytic uremic syndrome (aHUS) by requiring an immunosuppressive regimen.
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4D Molecular Therapeutics to present interim data on 4D-710 at the North American Cystic Fibrosis Conference. Company will host a webcast to discuss the data and provide a program update.
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The European Medicines Agency (EMA) has granted Priority Medicine (PRIME) designation to 4D-150, an investigational genetic medicine candidate for intravitreal treatment of wet age-related macular degeneration (wet AMD). The designation follows positive interim Phase 1 clinical data that demonstrated safety, tolerability, and clinical activity. 4D-150 has the potential to address an unmet medical need and maintain long-term visual acuity outcomes while avoiding repeated injections.
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4D Molecular Therapeutics appoints Uneek Mehra as Chief Financial & Business Officer
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4D Molecular Therapeutics to present at investor conferences in September and October
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4D Molecular Therapeutics enrolls first patient in Phase 2 SPECTRA trial for intravitreal 4D-150 in diabetic macular edema; adds Population Extension cohort to PRISM trial in wet AMD. FDA feedback on Phase 3 design expected in Q4 2023. Initial interim data for both trials expected in 2024.
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4D Molecular Therapeutics (Nasdaq: FDMT) reported positive interim data from intravitreal 4D-150 Phase 1/2 PRISM clinical trial for wet AMD and completed target enrollment ahead of schedule. They also presented positive interim data from aerosolized 4D-710 Phase 1/2 AEROW clinical trial for cystic fibrosis lung disease. The company entered a license agreement with Astellas Pharma and has a strong balance sheet with $310 million in cash. However, they reported a net loss of $29.6 million for the quarter.
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4D Molecular Therapeutics (Nasdaq: FDMT) announced positive interim clinical data from the Phase 1 Dose Exploration stage of the 4D-150 Phase 1/2 PRISM clinical trial for patients with wet age-related macular degeneration (wet AMD). The data showed favorable safety profile and clinical activity of intravitreal 4D-150 in reducing anti-VEGF treatment burden at all dose levels, with statistically significant results in the highest tested dose cohort. The company plans to present initial interim Phase 2 Dose Expansion data in H1 2024.
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4D Molecular Therapeutics, Inc.
Nasdaq:FDMT
FDMT Rankings
FDMT Stock Data
1.31B
31.64M
3.53%
85.52%
18.72%
Biological Product (except Diagnostic) Manufacturing
Manufacturing
United States of America
EMERYVILLE
About FDMT
the mission of 4d molecular therapeutics is to design and develop transformative gene therapy products using our proprietary technology to create novel adeno-associated virus variants to be utilized as treatments for serious unmet medical conditions. our products are unlocking the full potential of gene therapy to treat, and potentially cure, genetic diseases. a large number of patients and diseases, who previously were not treatable by gene therapy, will be addressable by 4d products. 4d has one of the deepest and most diverse product pipelines in the gene therapy field. adeno-associated virus (aav) vectors have emerged as a favored delivery vehicle for gene therapy in the human body. they can deliver the genes for therapeutic proteins to accessible tissues in the body and are generally considered safe. several aav gene therapy products are in late-stage clinical development, and one product is approved in the eu (glybera, uniqure). however, these first-generation aav vectors have lim