Board Change • Jul 01
High number of new directors There are 5 new directors who have joined the board in the last 3 years. Chair of Retina Advisory Board Arshad Khanani was the last director to join the board, commencing their role in 2024. The company’s lack of board continuity is considered a risk according to the Simply Wall St Risk Model. FDMT
Live News • Jul 01
4D Molecular Therapeutics Concludes Phase 3 4D-150 Trial Enrollment Early in Wet AMD 4D Molecular Therapeutics completed enrollment for its 4FRONT-2 global Phase 3 trial of lead gene therapy candidate 4D-150 in wet age-related macular degeneration, with over-enrollment achieved about four months ahead of projections and 52-week topline data targeted for the second half of 2027.
The faster-than-planned and over-enrolled study suggests strong engagement from clinicians and patients with 4D-150, which is being tested as a long-acting treatment option for blinding retinal vascular disease.
4D Molecular Therapeutics shares trade at $13.30, with the stock up 81.7% year to date, reflecting a market that is already assigning value to pipeline progress.
The key question from here is whether the eventual Phase 3 readout will support regulatory filings, since any disappointment or delay around the 2027 topline data could have an outsized impact on sentiment toward 4DMT. Announcement • Jun 29
4D Molecular Therapeutics Completes Enrollment for 4Front-2 Global Phase 3 Clinical Trial of 4D-150 in Wet Amd 4D Molecular Therapeutics announced enrollment completion for 4FRONT-2, the second Phase 3 clinical trial in its global program, evaluating 4D-150 in patients with wet age-related macular degeneration (wet AMD). 4FRONT-2 global enrollment was completed approximately 4 months ahead of initial projections. 4FRONT-2 was over-enrolled (anticipated N>500), with final patient randomization expected in the Third Quarter 2026. 4FRONT-2 52-week topline data is expected in the Second Half 2027. The high enrollment rate across both 4FRONT-1 and 4FRONT-2 trials, predominantly in treatment-naïve patients, reflects the enthusiasm of patients and retina physicians for 4D-150, as well as the high unmet medical need for a vision-preserving durable backbone therapy in wet AMD. Two Phase 3 readouts are expected in 2027 and initiation of a Phase 3 trial in diabetic macular edema in the Third Quarter of this year. 4FRONT-2 is a global Phase 3 multicenter, randomized, double-masked, aflibercept 2 mg (Q8W) comparator-controlled study of intravitreal 4D-150 in wet AMD that has enrolled both treatment-naïve and recently diagnosed treatment-experienced patients. The primary endpoint is non-inferiority in the mean change from baseline in best corrected visual acuity (BCVA) at 52 weeks. The key secondary endpoint is treatment burden reduction comparing the number of aflibercept injections received in the 4D-150 arm versus the aflibercept comparator arm over 52 weeks. Patients in both arms are eligible for supplemental aflibercept injections. 4FRONT-2 52-week topline data is expected in the Second Half 2027. 4FRONT-1, the first 4D-150 wet AMD Phase 3 trial, is being conducted in North America evaluating treatment-naïve patients with an otherwise identical design to 4FRONT-2. 4FRONT-1 52-week topline data is expected in the First Half 2027. 4D-150 is a potential backbone therapy designed to provide multi-year, and potentially lifelong, sustained delivery of anti-VEGF biologics (aflibercept and anti-VEGF-C) within the retina following a single intravitreal injection. 4D-150 utilizes a customized and evolved intravitreal AAV vector, R100, which was invented at 4DMT through its proprietary Therapeutic Vector Evolution platform. 4D-150 is being developed for wet AMD and diabetic macular edema (DME), which both affect millions of patients globally, with the goal of freeing patients from burdensome injections while preserving vision. Wet AMD, or wet age-related macular degeneration, is a highly prevalent disease, with more than 4 million individuals expected to be affected in the next five years in certain major markets, including the U.S., the EU and Japan. The disease also has a high incidence, with 200,000 individuals estimated to be newly diagnosed every year in the U.S. alone. Wet AMD is a type of macular degeneration in which abnormal blood vessels grow into the macula (macular neovascularization or MNV), the central area of the retina. MNV causes swelling and edema of the retina, bleeding and scarring, leading to visual distortion and reduced visual acuity. The proliferation and leakage of abnormal blood vessels is stimulated by VEGF. This process distorts and, without treatment, can potentially destroy central vision and may progress to blindness.