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4D Molecular Therapeutics, Inc. - FDMT STOCK NEWS

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.

News

4DMT Gains Alignment with FDA on Plan to Lift Clinical Hold on Phase 1/2 INGLAXA Clinical Trial for 4D-310 for Fabry Disease Cardiomyopathy

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4D Molecular Therapeutics has reached an agreement with the FDA to lift the clinical hold on the Phase 1/2 INGLAXA clinical trial for 4D-310, a treatment for Fabry disease cardiomyopathy. The company has shared the most up-to-date clinical activity and safety data with the FDA and plans to submit the results of a non-clinical study evaluating the safety and biodistribution of 4D-310 to the FDA in Q2 2024. The INGLAXA trial protocol has been amended to minimize the risk of atypical hemolytic uremic syndrome (aHUS) by requiring an immunosuppressive regimen.
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4DMT to Present Interim Data from Aerosolized 4D-710 Phase 1/2 AEROW Clinical Trial for Cystic Fibrosis at 2023 NACFC

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4D Molecular Therapeutics to present interim data on 4D-710 at the North American Cystic Fibrosis Conference. Company will host a webcast to discuss the data and provide a program update.
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4DMT Receives EMA Priority Medicines (PRIME) Designation for 4D-150 Clinical-Stage Genetic Medicine for Treatment of Wet AMD

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The European Medicines Agency (EMA) has granted Priority Medicine (PRIME) designation to 4D-150, an investigational genetic medicine candidate for intravitreal treatment of wet age-related macular degeneration (wet AMD). The designation follows positive interim Phase 1 clinical data that demonstrated safety, tolerability, and clinical activity. 4D-150 has the potential to address an unmet medical need and maintain long-term visual acuity outcomes while avoiding repeated injections.
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4DMT Appoints Uneek Mehra as Chief Financial and Business Officer

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4D Molecular Therapeutics appoints Uneek Mehra as Chief Financial & Business Officer
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4DMT to Participate in Upcoming Investor Conferences

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4D Molecular Therapeutics to present at investor conferences in September and October
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4DMT Announces First Patient Enrolled in 4D-150 Phase 2 SPECTRA Clinical Trial in DME, and Expansion of 4D-150 Phase 2 Stage in PRISM Clinical Trial in Wet AMD

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4D Molecular Therapeutics enrolls first patient in Phase 2 SPECTRA trial for intravitreal 4D-150 in diabetic macular edema; adds Population Extension cohort to PRISM trial in wet AMD. FDA feedback on Phase 3 design expected in Q4 2023. Initial interim data for both trials expected in 2024.
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4D Molecular Therapeutics Reports Second Quarter 2023 Financial Results and Operational Highlights

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4D Molecular Therapeutics (Nasdaq: FDMT) reported positive interim data from intravitreal 4D-150 Phase 1/2 PRISM clinical trial for wet AMD and completed target enrollment ahead of schedule. They also presented positive interim data from aerosolized 4D-710 Phase 1/2 AEROW clinical trial for cystic fibrosis lung disease. The company entered a license agreement with Astellas Pharma and has a strong balance sheet with $310 million in cash. However, they reported a net loss of $29.6 million for the quarter.
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4DMT Presents Additional Positive Interim Data from Intravitreal 4D-150 Phase 1/2 PRISM Clinical Trial in Patients with Wet AMD at ASRS 2023

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4D Molecular Therapeutics (Nasdaq: FDMT) announced positive interim clinical data from the Phase 1 Dose Exploration stage of the 4D-150 Phase 1/2 PRISM clinical trial for patients with wet age-related macular degeneration (wet AMD). The data showed favorable safety profile and clinical activity of intravitreal 4D-150 in reducing anti-VEGF treatment burden at all dose levels, with statistically significant results in the highest tested dose cohort. The company plans to present initial interim Phase 2 Dose Expansion data in H1 2024.
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4DMT Completes Enrollment of Phase 2 PRISM Clinical Trial for Intravitreal 4D-150 in Patients with Wet AMD and Reports Interim Safety and Tolerability Data

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Astellas and 4D Molecular Therapeutics (4DMT) Enter into License Agreement to Use 4DMT's Proprietary Intravitreal R100 Vector for Rare Ophthalmic Targets

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FAQ

What is the current stock price of 4D Molecular Therapeutics (FDMT)?

The current stock price of 4D Molecular Therapeutics (FDMT) is $6.31 as of December 20, 2024.

What is the market cap of 4D Molecular Therapeutics (FDMT)?

The market cap of 4D Molecular Therapeutics (FDMT) is approximately 279.7M.

What is 4D Molecular Therapeutics' core business?

4DMT focuses on developing transformative gene therapy products for ophthalmology, cardiology, and pulmonology using proprietary AAV vectors.

What recent achievements has 4D Molecular Therapeutics accomplished?

The company has shown promising interim data for 4D-310 in Fabry disease cardiomyopathy and initiated a Phase 3 clinical trial for 4D-150 in wet AMD.

What are the key products in 4DMT's pipeline?

Key products include 4D-150 for wet AMD, 4D-310 for Fabry disease, 4D-710 for cystic fibrosis, and 4D-725 for A1AT deficiency.

How is 4DMT financially positioned?

4DMT reported $589 million in cash equivalents in Q1 2024, sufficient to fund operations into the first half of 2027.

What partnerships has 4DMT established?

4DMT has strategic partnerships in gene editing and other areas to advance its diverse product pipeline.

What is the Therapeutic Vector Evolution platform?

It's 4DMT's proprietary platform that employs directed evolution to create novel AAV vectors tailored for specific therapeutic applications.

What is 4D-150 and what does it treat?

4D-150 is a gene therapy product for treating wet age-related macular degeneration (wet AMD) and diabetic macular edema (DME).

Where can I find more information about 4D Molecular Therapeutics?

Visit their website at www.4DMT.com and follow them on LinkedIn for updates and further details.

What are the clinical-stage products in 4DMT’s pipeline?

4DMT has five clinical-stage products: 4D-150, 4D-310, 4D-710, 4D-725, and 4D-175.

What is the significance of 4D-310's interim data for Fabry disease?

The data show significant improvements in cardiac function, exercise capacity, and quality of life, indicating strong clinical activity and safety.

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4D Molecular Therapeutics, Inc.

Nasdaq:FDMT

FDMT Rankings

#3592 Ranked by Market Cap
N/A Ranked by Dividends

FDMT Stock Data

279.68M
44.42M
3.91%
115.24%
16.93%
Biotechnology
Biological Products, (no Disgnostic Substances)
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United States of America
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