4D Molecular Therapeutics Inc. Stock Price, News & Analysis

4D Molecular Therapeutics (NASDAQ:FDMT) announced positive 60-week results from the SPECTRA clinical trial evaluating 4D-150 in diabetic macular edema (DME) patients. The Phase 3 dose (3E10 vg/eye) demonstrated significant efficacy with a 78% reduction in treatment burden compared to projected aflibercept treatment.

Key results include sustained visual acuity gains of +9.7 letters and anatomic improvement with CST reduction of -174 µm. The treatment was well-tolerated with no intraocular inflammation observed. Notably, patients receiving the Phase 3 dose required only 1.6 mean supplemental injections compared to 3.7 for lower doses and 7.0 projected for aflibercept.

Both FDA and EMA have aligned that a single Phase 3 clinical trial would be acceptable for regulatory submission for 4D-150 in DME, streamlining the path to potential approval.

4D Molecular Therapeutics (NASDAQ:FDMT) announced two upcoming presentations at the 43rd Annual Scientific Meeting of the American Society of Retina Specialists (ASRS) in Long Beach, CA, from July 30 – August 2, 2025.

The presentations will feature interim results from two clinical trials: the SPECTRA Phase 2a trial evaluating 4D-150 for Diabetic Macular Edema, including 52-week primary endpoint and 60-week analyses, and the PRISM Phase 2b trial evaluating 4D-150 for neovascular Age-related Macular Degeneration with 52-week results. Both presentations will be available on the company's website.

4D Molecular Therapeutics (Nasdaq: FDMT), a late-stage biotechnology company, has granted 4,600 Restricted Stock Units (RSUs) to one new non-executive employee on July 8, 2025. The RSUs were awarded under the Company's 2025 Employment Inducement Award Plan, which was established in February 2025 in accordance with Nasdaq Global Market Rule 5635(c)(4) to incentivize new employee recruitment.

4D Molecular Therapeutics (NASDAQ:FDMT) announced significant acceleration of its 4D-150 Phase 3 program for wet age-related macular degeneration (wet AMD). The 4FRONT-1 Phase 3 trial's topline data readout has been moved forward to H1 2027 from H2 2027, while the 4FRONT-2 Phase 3 trial was initiated ahead of schedule in June 2025.

The company implemented a 25% workforce reduction, primarily affecting early-stage R&D and support functions, expected to generate $15 million in annual cash savings. With $458 million in cash as of March 31, 2025, FDMT maintains its cash runway into 2028, supporting both Phase 3 trials, BLA preparation, and ongoing development programs in diabetic macular edema and cystic fibrosis.

4D Molecular Therapeutics (FDMT), a late-stage biotechnology company, has announced its participation in two major upcoming investor conferences in June 2025. The company's management will engage in fireside chats at the Jefferies Global Healthcare Conference on June 4 at 3:45 p.m. ET and the Goldman Sachs Global Healthcare Conference on June 11 at 11:20 a.m. ET. One-on-one meetings with management will be available, and webcasts of the presentations will be accessible for up to one year on the company's investor relations website.

4D Molecular Therapeutics (Nasdaq: FDMT) has announced the granting of employment inducement awards to eight new non-executive employees. On May 13, 2025, the company's compensation committee approved the issuance of 31,800 Restricted Stock Units (RSUs) under its 2025 Employment Inducement Award Plan. This plan was established in February 2025 and approved by the board of directors in compliance with Nasdaq Global Market Rule 5635(c)(4), which specifically allows for equity grants as employment inducements for new hires.

4D Molecular Therapeutics (FDMT) reported Q1 2025 financial results and key operational updates. The company has enrolled first patients in its 4D-150 Phase 3 clinical trial (4FRONT-1) for wet AMD, with over 50 clinical sites active. A second Phase 3 trial (4FRONT-2) is expected to begin in Q3 2025, with topline data from both trials anticipated in H2 2027.

The company maintains a strong financial position with $458 million in cash and equivalents as of March 31, 2025, expected to fund operations into 2028. Q1 2025 saw a net loss of $48.0 million, with R&D expenses of $40.7 million and G&A expenses of $12.9 million.

Notable achievements include receiving RMAT designation for 4D-150 in DME and positive Phase 1/2 trial results showing an 83% reduction in injection burden for wet AMD patients. The company has focused its pipeline on core programs 4D-150 and 4D-710, while pausing several other programs to extend cash runway.

4D Molecular Therapeutics (FDMT), a late-stage biotechnology company, has announced its participation in two major healthcare investor conferences in May 2025. The company's management will engage in fireside chats at the BofA Securities 2025 Healthcare Conference on May 14 at 2:20 p.m. PT and the RBC Capital Markets 2025 Global Healthcare Conference on May 21 at 9:00 a.m. ET. Management will also be available for one-on-one meetings with investors. Webcasts of both presentations will be accessible through the company's investor relations website for up to one year.

4D Molecular Therapeutics (FDMT) has achieved a significant milestone as the FDA granted Regenerative Medicine Advanced Therapy (RMAT) designation to 4D-150 for treating diabetic macular edema (DME). This marks 4D-150 as the first investigational medicine to receive RMAT designation for both DME and wet age-related macular degeneration (wet AMD). The designation, based on results from the ongoing SPECTRA DME study, suggests 4D-150's potential to maintain visual acuity improvements while reducing treatment burden. The RMAT status, part of the 21st Century Cures Act, will expedite development through enhanced FDA interaction. The company plans to advance 4D-150 into Phase 3 development with a single trial for DME approval, alongside two wet AMD 4FRONT Phase 3 clinical trials.