4D Molecular Therapeutics
🇺🇸United States
- Country
- 🇺🇸United States
- Ownership
- Public
- Established
- 2013-01-01
- Employees
- 147
- Market Cap
- $807M
- Introduction
4DMT operates as a clinical-stage genetic medicines company focused on inventing and developing genetic medicines to treat large market diseases in ophthalmology, pulmonology and cardiology. It develops genetic medicines using its proprietary invention platform, Therapeutic Vector Evolution. It combines the power of the Nobel Prize-winning technology, directed evolution, with approximately one billion synthetic AAV capsid-derived sequences. Its product design, development and manufacturing engine create a valuable and diverse product pipeline. The company is currently advancing five clinical-stage and two preclinical product candidates, each tailored to address rare and large market diseases. 4DMT was founded by David H. Kirn, Melissa Kotterman, Theresa Janke, and David Schaffer on September 12, 2013 and is headquartered in Emeryville, CA.
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REGENXBIO's ABBV-RGX-314 Reduces Need for AntiVEGF Injections After Application in ...
REGENXBIO's ABBV-RGX-314 gene therapy for wet AMD reduced antiVEGF injections by 97% in 9 patients with bilateral disease, with 78% injection-free post-treatment. Safety was well-tolerated, with no serious adverse events. This marks the first bilateral treatment for wet AMD, potentially offering a one-time effective treatment.
4DMT presents data from phase 1/2 PRISM clinical trial and outlines 4FRONT phase 3 study
4D Molecular Therapeutics presented positive interim data from Phase 1/2 PRISM study and 4FRONT Phase 3 study design for 4D-150 in wet AMD, showing robust and durable treatment burden reduction and favorable safety profile. The company plans to initiate 4FRONT-1 Phase 3 study in Q1 2025, aiming to bring a paradigm-shifting treatment option to patients.
Neuralink 'Blindsight' Brain Implant Gets FDA 'Breakthrough Device' Nod
Neuralink's 'Blindsight' implant gets FDA 'breakthrough device' designation, aiming to restore vision in blind individuals. Additionally, 4D Molecular Therapeutics reports positive data for macular degeneration gene therapy, reducing the need for standard-of-care injections.
4DMT's Gene Therapy for AMD Clears Phase II, Heads to Late-Stage Studies
4D Molecular Therapeutics' gene therapy 4D-150 showed durable clinical activity in Phase I/II PRISM study for wet AMD, reducing standard-of-care injections by 89% in 30 patients and 83% in 27 severe cases. The therapy was well-tolerated with a 2.8% incidence of intraocular inflammation. 4DMT plans to advance 4D-150 into Phase III 4FRONT program, targeting 500 patients starting Q1 2025.
4DMT shares data from Phase 1/2 PRISM clinical trial, 4FRONT Phase 3 study design
4D Molecular Therapeutics announced positive interim data from Phase 1/2 PRISM study for 4D-150 in wet AMD, showing potential durable, multiyear clinical benefit with a safety profile comparable to approved anti-VEGF agents. The company plans to initiate 4FRONT-1, a Phase 3 study in wet AMD, in Q1 2025.
FDA Activity Recap: August 2024 Features TCR T-Cell Therapy Approval, REMS
In August 2024, the FDA approved Adaptimmune Therapeutics’ afami-cel for synovial sarcoma, modified REMS for CAR-T therapies, lifted a hold on 4D Molecular Therapeutics’ Fabry disease gene therapy, provided guidance for IN8bio’s INB-100 in AML, and cleared Biosyngen’s BRG01 for a pivotal trial in EBV-positive nasopharyngeal carcinoma.
FDA Lifts Clinical Hold on Trial for 4D Molecular Therapeutics' 4D-310 Gene Therapy
FDA lifted the clinical hold on 4DMT's 4D-310 gene therapy trial for Fabry disease, allowing patient enrollment to continue. The therapy showed clinical improvements in cardiac function and quality of life, with resolved adverse events. 4DMT also advances other gene therapies, including 4D-150 for wet AMD.
4DMT Presents Interim Data from 4D-310 INGLAXA Phase 1/2 Clinical Trials for Fabry Disease Cardiomyopathy at WORLDSymposium™ 2024
4D-310 showed significant cardiac improvements in Fabry disease patients, with durable transgene expression and Gb3 clearance in cardiomyocytes. No new severe adverse events were reported. FDA submission for NHP study data is expected in Q2 2024. 4DMT's platform demonstrates efficient delivery and clinical activity.
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