Welcome to our dedicated page for 4D Molecular Therapeutics news (Ticker: FDMT), a resource for investors and traders seeking the latest updates and insights on 4D Molecular Therapeutics stock.
4D Molecular Therapeutics, Inc. (Nasdaq: FDMT) is a clinical-stage gene therapy company dedicated to developing transformative medicines for serious, unmet medical conditions. Utilizing its proprietary Therapeutic Vector Evolution platform, the company designs novel adeno-associated virus (AAV) vectors to treat genetic diseases.
Core Business: 4DMT focuses on three primary therapeutic areas: Ophthalmology, Cardiology, and Pulmonology. In ophthalmology, intravitreal vectors are employed for treatments like 4D-150 for wet age-related macular degeneration (wet AMD) and diabetic macular edema (DME). Cardiology projects include 4D-310 for Fabry disease cardiomyopathy, while pulmonology efforts are highlighted by 4D-710 for cystic fibrosis.
Recent Achievements: The company has shown promising interim safety and efficacy data for 4D-310 in treating Fabry disease cardiomyopathy, with significant improvements in cardiac function, exercise capacity, and quality of life. For 4D-150, positive interim results from the PRISM clinical trial indicate its potential as a best-in-class treatment for wet AMD, leading to the initiation of a Phase 3 clinical trial in 2025.
Partnerships and Financial Condition: 4DMT has established strategic partnerships and recently secured substantial financing, bolstering its financial health. The company reported $589 million in cash equivalents by Q1 2024, sufficient to fund operations into the first half of 2027.
Innovative Pipeline: 4DMT’s product candidates, currently in clinical and preclinical stages, include 4D-175 for geographic atrophy, 4D-725 for A1AT deficiency, and additional CNS programs through gene editing partnerships. The company’s advanced manufacturing processes support the potential commercialization of these therapies.
Learn more at www.4DMT.com and follow on LinkedIn.
4D Molecular Therapeutics (Nasdaq: FDMT) announced positive interim results from the Phase 2 PRISM trial for 4D-150 in wet AMD patients. The planned Phase 3 dose (3E10 vg/eye) showed an 89% reduction in annualized injection rate, with 93% of patients receiving 0 or 1 injection and 77% injection-free through Week 24. Visual acuity improved by +4.2 letters, with a dose response favoring the 3E10 vg/eye dose (+5.7 letters vs low dose).
The treatment demonstrated a favorable safety profile across 139 patients in wet AMD and DME trials, with no significant inflammation reported in 51 patients treated with the 3E10 vg/eye dose. Long-term follow-up showed sustained efficacy for up to 2.5 years. 4DMT plans to initiate Phase 3 trials in Q1 2025, with final design updates expected in September 2024.
4D Molecular Therapeutics (Nasdaq: FDMT) announced that the FDA has cleared its Investigational New Drug (IND) application for 4D-175, a genetic medicine for treating geographic atrophy (GA) secondary to age-related macular degeneration (AMD).
The 4D-175 leverages the R100 AAV vector and a codon-optimized transgene encoding a shortened form of human complement factor H (sCFH). GA affects over 5 million people globally. Enrollment for the Phase 1 GAZE clinical trial is expected to start in the second half of 2024.
The trial will explore safety, dose levels, and biological activity. Preclinical data demonstrated recovery from complement dysregulation and reduced retinal injury in animal models. The company aims to offer a single-injection treatment, potentially improving long-term vision outcomes.
4D-175 may notably reduce the treatment burden compared to current complement inhibitor treatments, which require frequent injections.
4D Molecular Therapeutics (Nasdaq: FDMT) will present initial interim 24-week data from its Phase 2 PRISM trial's Population Extension cohort on July 17, 2024, at the ASRS Annual Scientific Meeting in Stockholm. The analysis will cover 45 patients, focusing on safety and clinical activity. Additionally, a webcast will be held on the same day at 6:30 a.m. ET, featuring Dr. Arshad M. Khanani for detailed data discussion and Q&A. This study evaluates 4D-150 in treating neovascular age-related macular degeneration (AMD). A high-level safety update from PRISM and SPECTRA studies involving 139 patients will also be provided.
4D Molecular Therapeutics (Nasdaq: FDMT) presented injection-free subgroup analyses from its Phase 2 PRISM clinical trial evaluating 4D-150 in wet age-related macular degeneration (wet AMD) patients. Results showed that a single dose of 4D-150 maintained or improved visual acuity compared to the standard bimonthly aflibercept injections over 24 weeks. The treatment also resulted in a significant reduction in central subfield thickness (CST). The company plans to present interim results from the Population Extension cohort at the ASRS Annual Meeting on July 17, 2024, and will provide updates on Phase 3 trial designs later in the year.
4D Molecular Therapeutics (Nasdaq: FDMT) announced positive interim data from its Phase 1/2 AEROW clinical trial of aerosolized 4D-710 for treating cystic fibrosis (CF) lung disease. Clinically meaningful improvements in pulmonary function (ppFEV1) were observed in 2 of 3 participants with mild to moderate baseline lung function impairment over 12 months. The treatment was well tolerated across all doses up to 1E15 vg, and widespread CFTR transgene expression was observed in lung biopsies from all participants. The 1E15 vg dose has been cleared for Phase 2 Dose Expansion, expected to begin in H2 2024, with further interim data anticipated in mid-2025.
4D Molecular Therapeutics (Nasdaq: FDMT) announced its participation at the Clinical Trials at the Summit (CTS) Meeting in Park City, Utah, on June 8, 2024. The company will present 24-week data from the Phase 2 Dose Expansion Stage of the PRISM Trial evaluating 4D-150 in wet AMD patients with severe disease activity. The presentations will cover topics including designing registration trials with the latest FDA guidance and challenges in bringing new treatment options to market. Key speakers include Robert Kim, M.D., Carl Danzig, M.D., and David Kirn, M.D.
4D Molecular Therapeutics (Nasdaq: FDMT), a leader in genetic medicines, has announced its participation in key investor conferences in June 2024. The company will be represented at the Jefferies Global Healthcare Conference on June 6 at 2:30 p.m. ET and the Goldman Sachs Global Healthcare Conference on June 11 at 2:00 p.m. ET. These events will feature fireside chats and one-on-one meetings with the management team. Archived webcasts of these presentations will be available for up to a year on the 4DMT website for interested investors.
4D Molecular Therapeutics (Nasdaq: FDMT) will present interim data from the Phase 1/2 AEROW clinical trial of aerosolized 4D-710 for cystic fibrosis lung disease at the 47th European Cystic Fibrosis Conference on June 6, 2024. Dr. Jennifer L. Taylor-Cousar will present the data at 5:00 p.m. BST. The company will also host a webcast to discuss the data and provide a program update on the same day at 8:00 a.m. ET.
The presentation, titled 'CFTR transgene expression in airway epithelial cells following aerosolized administration of the AAV-based gene therapy 4D-710 to adults with cystic fibrosis lung disease,' will be part of the session 'Where are we with new therapeutic approaches?'
The webcast will be archived on the 4DMT website for one year.
4DMT reported positive interim data from the PRISM Phase 2 Dose Expansion cohort evaluating 4D-150 in wet AMD patients, advancing into Phase 3 by Q1 2025. They presented 24-week analysis from the Population Extension cohort and Phase 1/2 AEROW trial at upcoming conferences. Additionally, they completed a public follow-on offering raising $337 million, ensuring cash runway into H1 2027.
4D Molecular Therapeutics, a leading genetic medicines company, will participate in an investor conference in May. The management team will conduct a fireside chat and be available for one-on-one meetings. The presentation will take place on May 14, 2024, at the Bank of America Health Care Conference.
FAQ
What is 4D Molecular Therapeutics' core business?
What recent achievements has 4D Molecular Therapeutics accomplished?
What are the key products in 4DMT's pipeline?
How is 4DMT financially positioned?
What partnerships has 4DMT established?
What is the Therapeutic Vector Evolution platform?
What is 4D-150 and what does it treat?
Where can I find more information about 4D Molecular Therapeutics?
What are the clinical-stage products in 4DMT’s pipeline?
What is the significance of 4D-310's interim data for Fabry disease?
