Conducted initial pivotal study interactions with the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA); Company has clear registration path for 4D-710 for treatment of cystic fibrosis (CF) lung disease in people with CF (pwCF) who are ineligible for or cannot tolerate approved CF modulator therapies AEROW clinical trial Phase 2 Expansion Cohort dose selection and initiation expected in Q2 2024,... Read More

EMERYVILLE, Calif., March 04, 2024 (GLOBE NEWSWIRE) -- 4D Molecular Therapeutics (Nasdaq: FDMT, 4DMT or the Company), a leading clinical-stage genetic medicines company focused on unlocking the full potential of genetic medicines to treat large market diseases, today announced that management will participate in fireside chats at upcoming investor conferences in March. Members of the management team will also be available... Read More

Presented positive interim data from randomized Dose Expansion cohort of the Phase 2 PRISM study evaluating 4D-150 in wet AMD patients with severe disease activity and high treatment burden, enabling advancement into Phase 3 pivotal development, with initiation expected in Q1 2025 Positive interim clinical data for 4D-710 in cystic fibrosis and 4D-310 in Fabry disease continue to demonstrate the potential of these product... Read More

4D-310 demonstrated clinically meaningful cardiac endpoint improvements through 12-24 months in contractility (echocardiography), peak VO 2 (cardiopulmonary exercise testing) and/or cardiac quality of life (KCCQ) in all five evaluable patients Cardiac biopsies were obtained from a patient at week 6 and 24 and showed robust and durable delivery, transgene expression and clearance of Gb3 substrate in cardiomyocytes No new... Read More

EMERYVILLE, Calif., Feb. 06, 2024 (GLOBE NEWSWIRE) -- 4D Molecular Therapeutics, Inc. (Nasdaq: FDMT), a leading clinical-stage genetic medicines company focused on unlocking the full potential of genetic medicines to treat large market diseases, announced today that it priced an upsized underwritten public offering of 6,586,015 shares of its common stock at a public offering price of $29.50 per share and, in lieu of shares... Read More

EMERYVILLE, Calif., Feb. 05, 2024 (GLOBE NEWSWIRE) -- 4D Molecular Therapeutics, Inc. (Nasdaq: FDMT), a leading clinical-stage genetic medicines company focused on unlocking the full potential of genetic medicines to treat large market diseases, announced today that it has commenced an underwritten public offering of $250.0 million of shares of its common stock. 4D Molecular Therapeutics also intends to grant the... Read More

51 wet AMD patients with severe disease activity (mean of 442 µm central subfield thickness & presence of retinal fluid) and high treatment burden (mean of 10 anti-VEGF injections in preceding 12 months) were randomized to high (3E10 vg/eye) or low (1E10 vg/eye) dose 4D-150 or aflibercept control regimen 4D-150 was well tolerated with a favorable safety profile when evaluated through up to 48 weeks of follow-up: no... Read More

Initial interim landmark data analysis (N=50 at 24 Weeks) will be presented by Arshad M. Khanani, M.D., M.A., FASRS, Principal Investigator of the PRISM clinical trial at Angiogenesis, Exudation, and Degeneration 2024 Conference on Saturday, February 3, 2024 during Session VI (3:30 to 5:00 p.m. ET) Company to host webcast on Monday, February 5, 2024 at 8:00 a.m. ET EMERYVILLE, Calif., Jan. 29, 2024 (GLOBE NEWSWIRE) -- 4D... Read More

4D-710 has demonstrated promising, reproducible, CFTR expression significantly above normal levels for seven patients across Cohorts 1 & 2 (1E15-2E15 vg) and durable improvement or stabilization of quality of life & pulmonary function for three patients through 12 months in Cohort 1 Given above normal CFTR transgene expression (~400% of normal lung levels), dose exploration continues with evaluation of lower doses (Cohort 3... Read More

Poised for multiple meaningful catalysts in 2024 driven by strong clinical progress across large market programs in wet age-related macular degeneration (wet AMD), diabetic macular edema (DME) and cystic fibrosis (CF) Established next-generation AAV & CRISPR/Cas-based genetic medicines partnership for central nervous system (CNS) diseases with Arbor Biotechnologies Announced organizational updates, including the appointment... Read More

Partnership brings together two leaders in next-generation genetic medicines to engineer, co-develop and co-commercialize (50:50 profit share) AAV-delivered CRISPR/Cas-based therapeutics for up to six product candidates in CNS Initial product candidate will be developed for a target in amyotrophic lateral sclerosis (ALS) with additional targets expected to be in diseases with high unmet need in both rare and large patient... Read More

Designation follows interim Phase 1 PRISM clinical data for 4D-150 that demonstrated an encouraging safety, tolerability and clinical activity profile in patients with wet age-related macular degeneration (wet AMD) 4D-150 is the first therapeutic candidate to receive either RMAT or Breakthrough Designation for wet AMD RMAT designation follows Priority Medicines (PRIME) designation received from the European Medicines Agency... Read More

Initial interim landmark data analysis (N=50 at 24 Weeks) to be presented by Arshad M. Khanani, M.D., M.A., FASRS, Principal Investigator of the PRISM clinical trial, on Saturday, February 3, 2024 at 4:20 p.m. ET EMERYVILLE, Calif., Dec. 04, 2023 (GLOBE NEWSWIRE) -- 4D Molecular Therapeutics (Nasdaq: FDMT, 4DMT or the Company), a clinical-stage biotherapeutics company with three novel, highly targeted next generation AAV... Read More

EMERYVILLE, Calif., Nov. 15, 2023 (GLOBE NEWSWIRE) -- 4D Molecular Therapeutics, Inc. (Nasdaq: FDMT, 4DMT, or the Company), a genetic medicines company with three novel, highly targeted next generation AAV vectors currently in human clinical studies, announced today that management will participate in a fireside chat at an upcoming investor conference in November. Members of the management team will also be available for... Read More

Rapidly advanced 4D-150 development for wet age-related macular degeneration (wet AMD): completed enrollment of PRISM Phase 2 Dose Expansion nearly two quarters earlier than expected and enrolled first patient in Population Extension cohort Interim data update from 4D-150 PRISM Phase 2 Dose Expansion (n=50; high anti-VEGF need patients) in wet AMD expected in early 2024; update on FDA feedback on Phase 3 pivotal trial plans... Read More

Aerosolized 4D-710 was generally well tolerated with no inflammation in any lung biopsy across Cohorts 1 and 2 (1E15 & 2E15 vg; n=7) with up to 17 months follow-up Promising, reproducible, CFTR expression significantly above normal levels across all participants and all lung tissue samples collected (n=34), substantially exceeding target profile Durable clinical activity demonstrated by improvements in quality of life by... Read More

Initiated single non-human primate (NHP) safety study evaluating intravenous 4D-310 combined with rituximab/sirolimus (R/S) immunosuppressive regimen Amended INGLAXA protocol to minimize risk of atypical hemolytic uremic syndrome (aHUS) associated with intravenous (IV) AAV dosing, including addition of R/S immunosuppressive regimen 4D-310 combines a novel, targeted next generation AAV vector (C102) and GLA transgene for a... Read More

4D-710 interim data to be presented in plenary and symposium sessions at the North American Cystic Fibrosis Conference in Phoenix, Arizona held on November 2-4, 2023 Company to host webcast on Wednesday, November 1, 2023 at 4:30 p.m. ET EMERYVILLE, Calif., Oct. 25, 2023 (GLOBE NEWSWIRE) -- 4D Molecular Therapeutics (Nasdaq: FDMT, 4DMT or the Company), a clinical-stage genetic medicines company with three novel, highly... Read More

The European Medicines Agency’s priority medicines status is granted to drug candidates that may offer a major therapeutic advantage over existing treatments or benefit patients without treatment options 4D-150 combines a novel, targeted intravitreal next generation AAV vector with a dual transgene that inhibits four VEGF pathway targets (VEGF A, B, C, and PlGF) in wet age-related macular degeneration (wet AMD) and diabetic... Read More

EMERYVILLE, Calif., Sept. 12, 2023 (GLOBE NEWSWIRE) -- 4D Molecular Therapeutics (Nasdaq: FDMT, 4DMT or the Company), a clinical-stage biotherapeutics company harnessing the power of directed evolution for targeted genetic medicines, today announced the appointment of Uneek Mehra as Chief Financial & Business Officer of 4DMT. Mr. Mehra will succeed August J. Moretti, J.D., who is retiring, and has agreed to serve in an... Read More

EMERYVILLE, Calif., Sept. 07, 2023 (GLOBE NEWSWIRE) -- 4D Molecular Therapeutics, Inc. (Nasdaq: FDMT, 4DMT), a clinical-stage biotherapeutics company harnessing the power of directed evolution for genetic medicines targeting large market diseases, announced today that management will present company overviews and participate in fireside chats at upcoming investor conferences in September and October. Members of the... Read More

First patient has been enrolled in the Dose Confirmation stage (n=18) of the Phase 2 SPECTRA clinical trial for intravitreal 4D-150 in patients with diabetic macular edema First patient enrolled in Population Extension cohort of Phase 2 stage of PRISM clinical trial in wet AMD (n=up to 45) to evaluate intravitreal 4D-150 in patients with lower anti-VEGF need compared with initial cohorts All PRISM patient cohorts to inform... Read More

Presented positive interim data from intravitreal 4D-150 Phase 1/2 PRISM clinical trial for patients with wet age-related macular degeneration (wet AMD) Completed target enrollment of 50 patients in the randomized Phase 2 Dose Expansion stage of the PRISM clinical trial in July, nearly two quarters ahead of initially projected enrollment completion Presented positive interim data from aerosolized 4D-710 Phase 1/2 AEROW... Read More

Dose response demonstrated in favor of highest tested dose of 3E10 vg/eye, including 100% reduction in supplemental anti-VEGF injections (4 of 4 evaluable patients injection-free) and a clinically meaningful reduction in mean central subfield thickness (CST) at 36 weeks in patient population with high anti-VEGF need Assessment... Read More

Completed target enrollment of 50 patients in the randomized Phase 2 Dose Expansion stage of the PRISM clinical trial over approximately two quarters, nearly two quarters ahead of initial projections No reported treatment-emergent Grade ≥1 inflammatory cells or required deviations from protocol-specified topical corticosteroid taper, and no hypotony or treatment-related serious adverse events with maximum follow-up through... Read More

TOKYO and EMERYVILLE, Calif. , July 10, 2023 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503) (President and CEO: Naoki Okamura , "Astellas") and 4D Molecular Therapeutics, Inc. (NASDAQ: FDMT) (CEO: David Kirn , MD, "4DMT") today announced a license agreement under which Astellas gains rights to utilize the intravitreal retinotropic R100* vector invented by 4DMT for one genetic target implicated in rare monogenic ophthalmic... Read More

Reported data from cohort 1 (n=3, 1E15 vg dose) of cystic fibrosis modulator treatment ineligible/intolerant participants with 9-12 months follow-up Quality of life outcomes measured by Cystic Fibrosis Questionnaire-Revised respiratory symptom score (CFQ-R-R) meaningfully improved for all three participants Percent predicted... Read More

EMERYVILLE, Calif., June 01, 2023 (GLOBE NEWSWIRE) -- 4D Molecular Therapeutics, Inc. (Nasdaq: FDMT), a clinical-stage biotherapeutics company harnessing the power of directed evolution for genetic medicines targeting large market diseases, announced today it will participate in the following upcoming investor conferences: Jefferies Global Healthcare Conference Fireside Chat Date: Friday, June 9, 2023 Fireside Chat Time:... Read More

Interim data to be presented in an oral presentation by Dr. Jennifer L. Taylor-Cousar, MD, MSCS at the 2023 ECFS Annual Meeting in Vienna, Austria on Thursday, June 8, 2023 at 5:00 p.m. CET (11:00 a.m. ET) Company to host live webcast on Wednesday, June 7, 2023 at 4:30 p.m. ET EMERYVILLE, Calif., May 24, 2023 (GLOBE NEWSWIRE) -- 4D Molecular Therapeutics (Nasdaq: FDMT, 4DMT or the Company), a clinical-stage biotherapeutics... Read More

EMERYVILLE, Calif., May 11, 2023 (GLOBE NEWSWIRE) -- 4D Molecular Therapeutics (Nasdaq: FDMT), a clinical-stage biotherapeutics company harnessing the power of directed evolution for targeted genetic medicines, today announced a presentation on 4D-710 for the treatment of cystic fibrosis lung disease at the American Society of Gene & Cell Therapy (ASGCT) 26th Annual Meeting held in Los Angeles, California on May 16-20, 2023.... Read More

Presented positive interim data from intravitreal 4D-150 Phase 1/2 PRISM clinical trial for wet age-related macular degeneration (wet AMD) at the 2023 ARVO Annual Meeting On track for completion of enrollment of the Phase 2 Dose Expansion Stage of the PRISM clinical trial in Q3 Acquired all worldwide rights to short-form human complement factor H (sCFH) from Aevitas Therapeutics, Inc. and announced sCFH as payload for 4D-175... Read More

EMERYVILLE, Calif., May 09, 2023 (GLOBE NEWSWIRE) -- 4D Molecular Therapeutics, Inc. (Nasdaq: FDMT), a clinical-stage biotherapeutics company harnessing the power of directed evolution for genetic medicines targeting large market diseases, announced today the closing of an upsized underwritten public offering of 8,625,000 shares of its common stock at a public offering price of $16.00 per share. The shares of common stock... Read More

EMERYVILLE, Calif., May 08, 2023 (GLOBE NEWSWIRE) -- 4D Molecular Therapeutics, Inc. (Nasdaq: FDMT), a clinical-stage biotherapeutics company harnessing the power of directed evolution for genetic medicines targeting large market diseases, announced today it will participate in the following upcoming investor conferences: BofA Securities 2023 Health Care Conference Fireside Chat Date: Tuesday, May 9, 2023 Fireside Chat Time:... Read More

EMERYVILLE, Calif., May 04, 2023 (GLOBE NEWSWIRE) -- 4D Molecular Therapeutics, Inc. (Nasdaq: FDMT), a clinical-stage biotherapeutics company harnessing the power of directed evolution for genetic medicines targeting large market diseases, announced today that it priced an upsized underwritten public offering of 7,500,000 shares of its common stock at a public offering price of $16.00 per share. In addition, 4D Molecular... Read More

EMERYVILLE, Calif., May 04, 2023 (GLOBE NEWSWIRE) -- 4D Molecular Therapeutics, Inc. (Nasdaq: FDMT), a clinical-stage biotherapeutics company harnessing the power of directed evolution for genetic medicines targeting large market diseases, announced today that it has commenced an underwritten public offering of $100.0 million of shares of its common stock. 4D Molecular Therapeutics also intends to grant the underwriters a... Read More

Intravitreal 4D-150 was well-tolerated with no inflammation in 14 of 15 patients and only trace mixed cells at a single timepoint in one patient; no dose-limiting toxicities, treatment-related serious adverse events (SAE) or hypotony reported across all three dose cohorts with follow-up of 24 – 64 weeks Dose response demonstrated in favor of high dose 3E10 vg/eye, including superior reduction in supplemental anti-VEGF... Read More

4DMT acquires all world-wide rights to short-form human complement factor H (sCFH) from Aevitas Therapeutics, Inc.; technology invented at University of Pennsylvania Announces sCFH as payload for 4D-175 lead product candidate for geographic atrophy (GA); sCFH extensively characterized in 3 genetic mouse models and in non-human primates (NHP) CFH variants with reduced complement inhibitory function are a well-validated... Read More

Interim data to be presented in an oral presentation by Dr. Arshad M. Khanani, M.D., M.A., FASRS at the 2023 ARVO Annual Meeting on Thursday, April 27, 2023 at 11:30 a.m. ET Promoted Robert Kim, M.D. from SVP to Chief Medical Officer and Therapeutic Head, Ophthalmology Company to host live webcast on Thursday, April 27, 2023 at 8:00 a.m. ET EMERYVILLE, Calif., April 13, 2023 (GLOBE NEWSWIRE) -- 4D Molecular Therapeutics... Read More

Provided updates on clinical pipeline, including 4D-150 for wet age-related macular degeneration (wet AMD) and diabetic macular edema (DME), 4D-710 for cystic fibrosis lung disease, and 4D-310 for Fabry disease cardiomyopathy Demonstrated robust clinical gene delivery, tolerability and initial biological activity with first three customized and evolved vectors generated from Therapeutic Vector Evolution platform Expanded... Read More

All three patients with 12 months of follow-up demonstrated improvement in multiple FDA-recommended cardiac endpoints at relatively low dose of 1E13 vg/kg Cardiac biopsy demonstrated selective and widespread transgene expression within ~50% of cardiomyocytes Engaging with FDA to lift clinical hold and resume enrollment with updated exclusion criteria and highly effective rituximab/sirolimus immunosuppressive regimen to... Read More

Company to host live webcast on Wednesday, February 22, at 4:30 p.m. EST Platform presentation to be presented at WORLDSymposium™ on Saturday, February 25 EMERYVILLE, Calif., Feb. 16, 2023 (GLOBE NEWSWIRE) -- 4D Molecular Therapeutics (Nasdaq: FDMT, ‘4DMT’), a clinical-stage biotherapeutics company harnessing the power of directed evolution for targeted genetic medicines, today announced that the Company will host a live... Read More

EMERYVILLE, Calif., Feb. 08, 2023 (GLOBE NEWSWIRE) -- 4D Molecular Therapeutics (Nasdaq: FDMT, ‘4DMT’), a clinical-stage biotherapeutics company harnessing the power of directed evolution for targeted genetic medicines, today announced that the Company will present at the SVB Securities Global Biopharma Conference. David Kirn, M.D., Co-founder and Chief Executive Officer of 4DMT, will participate in a virtual fireside chat... Read More

4D-150 Phase 2 SPECTRA clinical trial for diabetic macular edema enrollment is expected to initiate in Q3 2023 Initial Phase 1 PRISM clinical trial with 4D-150 for wet age-related macular degeneration further validates R100 intravitreal vector potential for other large market eye diseases including geographic atrophy Interim PRISM data for dose Cohorts 1, 2, & 3 (n=15) to be presented at the 2023 Association for Research in... Read More

Expands Large Market Ophthalmology Portfolio Following Positive Clinical Data in wet Age-Related Macular Degeneration to Include Diabetic Macular Edema Clinical Program and Geographic Atrophy Preclinical Program Expands Large Market Pulmonology Portfolio Following Positive Clinical Data in Cystic Fibrosis to Include Alpha-1 Antitrypsin Deficiency Preclinical Program Reports Program Updates and Interim Clinical Data from... Read More