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 late-stage biotechnology company developing durable, disease-targeted genetic medicines. News about 4D Molecular Therapeutics often focuses on progress in its lead programs, 4D-150 for retinal vascular diseases and 4D-710 for cystic fibrosis lung disease, as well as corporate, financial and partnership developments.
For ophthalmology, company updates highlight clinical data and milestones for 4D-150 in wet age-related macular degeneration and diabetic macular edema. These include interim results from the PRISM Phase 1/2 trial, enrollment and design details for the 4FRONT Phase 3 program, and plans for global Phase 3 trials in DME. News items also cover collaborations, such as the license and development agreement with Otsuka Pharmaceutical for 4D-150 in Asia-Pacific markets.
In pulmonology, 4DMT news includes interim clinical data from the AEROW Phase 1/2 trial of 4D-710 in cystic fibrosis lung disease, describing CFTR transgene expression, lung function measures and dose selection for Phase 2. Additional coverage addresses external support, including an equity investment from the Cystic Fibrosis Foundation to help advance 4D-710.
Investors can also find announcements on equity offerings, cash runway guidance, leadership changes, board appointments, employment inducement grants and participation in healthcare and investor conferences. This news page aggregates these updates so readers can follow clinical progress, strategic partnerships, capital markets activity and governance developments related to FDMT over time.
4D Molecular Therapeutics (Nasdaq: FDMT) announced positive interim data for 4D-150, its gene therapy candidate for wet age-related macular degeneration (wet AMD). The Phase 1/2 PRISM trial showed robust and durable clinical activity across all wet AMD patient populations:
- In the broad population (Phase 2b), 70% were injection-free through 52 weeks
- In the severe population (Phase 1/2a), there was an 83% overall reduction in annualized injections through 52 weeks
- 4D-150 demonstrated a favorable safety profile with intraocular inflammation rates similar to approved anti-VEGF agents
The company plans to initiate the 4FRONT-1 Phase 3 study in Q1 2025, comparing a single dose of 4D-150 to aflibercept in recently diagnosed, treatment-naïve wet AMD patients. The trial design aims to maximize clinical, regulatory, and commercial success potential across global markets.
4D Molecular Therapeutics (Nasdaq: FDMT) has announced upcoming presentations at two major retina conferences. At the Retina Society 57th Annual Scientific Meeting in Lisbon on September 15, 2024, Dr. David Eichenbaum will present interim results from the PRISM Phase 1/2 clinical trial of intravitreal 4D-150 for neovascular age-related macular degeneration (AMD).
At the 24th EURETINA Congress in Barcelona on September 19, 2024, Dr. Arshad M. Khanani will provide an update on gene therapy for neovascular AMD. Additionally, Dr. Allen Hu will present interim 24-week results from a randomized Phase 2 clinical trial evaluating 4D-150 in high-need patients with wet AMD. These presentations will also be available on the 4DMT website.
4D Molecular Therapeutics (Nasdaq: FDMT), a clinical-stage genetic medicines company, has announced its participation in the 2024 Cantor Global Healthcare Conference. The company's management will engage in a fireside chat on Thursday, September 19, 2024, at 8:35 a.m. ET. Additionally, they will be available for one-on-one meetings with investors.
A live webcast of the presentation will be accessible, and an archived version will remain available for up to one year on the company's website. This event provides an opportunity for 4DMT to showcase its progress in developing genetic medicines for large market diseases and engage with the investment community.
4D Molecular Therapeutics (Nasdaq: FDMT) is set to host a 4D-150 Wet AMD Development Day on September 18, 2024 at 4:15 p.m. ET. The event will showcase the company's product development strategy for 4D-150 and present Phase 1/2 PRISM clinical trial data in wet age-related macular degeneration (wet AMD), including the longest available interim follow-up data.
The agenda includes presentations on the 4D-150 Phase 1/2 development strategy, featuring details on clinical trial design, treatment cohorts, and study objectives. Data presentation will cover interim follow-up results from various cohorts and dose levels, with efficacy data focusing on supplemental aflibercept injections, Best Corrected Visual Acuity (BCVA), and Central Subfield Thickness (CST). The event will also provide an overview of the 4FRONT Phase 3 clinical trial program in wet AMD.
A KOL panel featuring renowned retinal disease experts will participate in discussions and a live Q&A session alongside senior company leadership.
4D Molecular Therapeutics (Nasdaq: FDMT), a clinical-stage genetic medicines company, has announced its participation in the H.C. Wainwright 4th Annual Ophthalmology Virtual Conference. The company's management will engage in a fireside chat and be available for one-on-one meetings during the event.
Key details of the presentation:
- Date: Thursday, August 15, 2024
- Time: 12:00 p.m. ET
A webcast of the presentation will be available, and an archived version will be accessible for up to one year on the company's investor relations website. This event provides an opportunity for 4DMT to showcase its progress in developing genetic medicines for large market diseases, particularly in the field of ophthalmology.
4D Molecular Therapeutics (Nasdaq: FDMT) reported Q2 2024 financial results and operational highlights. Key points include:
1. Positive interim results from Phase 2 PRISM trial for 4D-150 in wet AMD
2. Strengthened leadership team and formed Ophthalmology Advisory Board
3. FDA removed clinical hold on Phase 1/2 INGLAXA study for 4D-310 in Fabry disease
4. $578 million in cash as of June 30, 2024, expected to fund operations into H1 2027
5. R&D expenses increased to $31.9 million in Q2 2024
6. Net loss of $35.0 million in Q2 2024
7. Upcoming milestones include PRISM trial data presentation at EURETINA Congress and initiation of Phase 3 trial for 4D-150 in wet AMD in Q1 2025
4D Molecular Therapeutics (Nasdaq: FDMT) has strengthened its leadership in large market ophthalmology with key senior management hires and the formation of an Ophthalmology Advisory Board. The company appointed Dhaval Desai as Chief Development Officer, Christopher Simms as Chief Commercial Officer, and Carlos Quezada-Ruiz as SVP, Therapeutic Area Head, Ophthalmology. These appointments bring extensive experience in ophthalmology drug development, regulatory affairs, and commercialization to 4DMT.
The company also announced the formation of an Ophthalmology Advisory Board chaired by Dr. Arshad M. Khanani, comprising world-renowned retina specialists. This board will support development strategy and registration across large market ophthalmology indications including wet AMD, DME, DR, and GA. These strategic moves position 4DMT for advancement in late-stage development, particularly for its promising 4D-150 program.
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.