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4DMT Completes Enrollment for 4FRONT-1 Phase 3 Clinical Trial of 4D-150 in Wet AMD
Globenewswire· 2026-02-09 13:00
Core Insights - 4D Molecular Therapeutics has completed enrollment for the 4FRONT-1 Phase 3 clinical trial of 4D-150 in patients with wet age-related macular degeneration (wet AMD) [1][4] - The trial achieved enrollment in approximately 11 months, exceeding initial projections and reflecting strong interest from both investigators and patients [2][4] - Topline data from the 4FRONT-1 trial is expected in the first half of 2027, with a second Phase 3 trial, 4FRONT-2, on track for completion in the second half of 2026 [4] Company Overview - 4D Molecular Therapeutics is a late-stage biotechnology company focused on developing durable and disease-targeted therapeutics, particularly for retinal diseases [7] - The lead product candidate, 4D-150, aims to provide sustained delivery of anti-VEGF biologics through a single intravitreal injection, potentially reducing the treatment burden for patients [5][7] - The company is also developing 4D-710, a genetic medicine for cystic fibrosis, demonstrating its commitment to innovative therapeutic solutions [7] Clinical Trial Details - The 4FRONT-1 trial is a multicenter, randomized, double-masked study comparing intravitreal 4D-150 to aflibercept, with the primary endpoint being non-inferiority in best corrected visual acuity (BCVA) at 52 weeks [2][4] - The trial is specifically targeting treatment-naïve wet AMD patients across North America, with plans for supplemental aflibercept injections for participants [2][4] - The second Phase 3 trial, 4FRONT-2, will include both treatment-naïve and recently diagnosed treatment-experienced patients, with an identical design to 4FRONT-1 [4] Market Context - Wet AMD is a prevalent condition, with over 4 million individuals expected to be affected in major markets within the next five years, and 200,000 new diagnoses annually in the U.S. [6] - The disease is characterized by abnormal blood vessel growth in the retina, leading to vision loss, which underscores the need for effective treatment options [6]
Barclays Flags M&A Tailwinds and Pricing Relief as Upside Catalysts for 4D Molecular Therapeutics, Inc. (FDMT)
Yahoo Finance· 2026-02-02 14:53
Company Overview - 4D Molecular Therapeutics, Inc. (NASDAQ:FDMT) is a clinical-stage biotechnology company focused on developing targeted gene therapies using its proprietary Therapeutic Vector Evolution platform [4]. Clinical Developments - The company is conducting the 4FRONT Phase 3 investigations of 4D-150 for Wet AMD, involving 480 patients in each phase, with 381 participants already randomized for 4FRONT-1. Global enrollment for 4FRONT-2 is expected to be completed by the second half of 2026 [3]. - A global Phase 3 trial for diabetic macular edema is scheduled for Q3 2026, and results from the 2-year SPECTRA Phase 1/2 trial are anticipated in the second half of 2026. Additionally, updates on the Phase 2 4D-710 program for cystic fibrosis are expected in the same timeframe [3]. Market Position and Analyst Ratings - Barclays initiated coverage of FDMT with an Overweight rating and a price target of $33, citing solid fundamentals in the biotech industry, the undervaluation of several companies, and anticipated tailwinds from mergers and acquisitions [2][3]. - The report highlights pricing relief as a potential upside catalyst for FDMT and the broader biotech sector [2][3].
4D Molecular Therapeutics, Inc. (FDMT) Presents at 44th Annual J.P. Morgan Healthcare Conference - Slideshow (NASDAQ:FDMT) 2026-01-19
Seeking Alpha· 2026-01-19 23:02
Group 1 - The article discusses the importance of enabling Javascript and cookies in browsers to prevent access issues [1] - It highlights that users with ad-blockers may face restrictions when trying to access content [1]
4D Molecular Therapeutics, Inc. (FDMT) Presents at 44th Annual J.P. Morgan Healthcare Conference Transcript
Seeking Alpha· 2026-01-14 18:35
Company Overview - 4D Molecular Therapeutics is focused on developing innovative solutions for retinal care, aiming to eliminate the need for lifelong injections [2][3] - The company is led by Dr. David Kirn, who serves as the Co-Founder and CEO [2] Product Pipeline - The lead product candidate of 4D Molecular Therapeutics is 4D-150, which targets neovascular diseases of the retina [3] - The presentation will outline the company's recent accomplishments and future potential, particularly regarding 4D-150 [2][3] Market Potential - The presentation will discuss the size and growth of the markets related to retinal care, highlighting significant unmet medical needs [3] - There is an emphasis on the importance of addressing these unmet needs to capture market opportunities [3] Development Strategy - The company will outline its strategy for Phase III trials and commercialization, focusing on derisking the approval process and enhancing commercial potential [3]
4D Molecular Therapeutics (NasdaqGS:FDMT) FY Conference Transcript
2026-01-14 16:32
Summary of 4D Molecular Therapeutics FY Conference Call Company Overview - **Company**: 4D Molecular Therapeutics (NasdaqGS:FDMT) - **Industry**: Biotechnology, specifically focusing on genetic medicines for retinal diseases Core Points and Arguments Product Pipeline and Development - **Lead Product**: 4D-150, targeting neovascular diseases of the retina, specifically wet AMD and diabetic macular edema (DME) [2][3] - **Clinical Trials**: Two ongoing Phase 3 trials for wet AMD with excellent enrollment; a Phase 3 trial for DME expected to initiate in Q3 2026 [4][6] - **Safety and Efficacy**: Strong Phase 1 and 2 results reported, with no significant inflammation observed in over 80 patients [5][6][26] - **Durability**: Promises a significant reduction in treatment burden, with an 80-90% reduction in the need for injections compared to traditional therapies [24][30] Market Opportunity - **Market Size**: The retinal vascular disease market is approximately $17 billion annually, with $14 billion specifically for wet AMD and DME [12] - **Patient Population**: Approximately 9 million people in the U.S., Europe, and Japan suffer from these diseases, with 600,000 new diagnoses each year [12][13] - **Unmet Needs**: Current treatments require lifelong injections, leading to high discontinuation rates (40% within a year) due to the burden of therapy [17][18] Regulatory and Commercial Strategy - **Regulatory Designations**: Received RMAT designation for DME and wet AMD, indicating recognition of the unmet medical need [7][32] - **Partnerships**: Collaboration with Otsuka for Asia-Pacific rights, retaining U.S. and European rights; the deal includes $135 million in upfront and cost coverage [4][49] - **Financial Position**: Closed a $100 million raise in Q4 2025, providing a runway into the second half of 2028 [8][39] Team and Expertise - **Leadership Team**: Comprised of industry veterans with extensive experience in retina therapeutics, including prior roles at Novartis and Iveric [10][11] - **External Engagement**: Strong pre-commercial team engaging with physicians, indicating high interest in gene therapy solutions [44][46] Additional Important Content - **Patient Journey**: Emphasizes the emotional and psychological burden of current treatment regimens on patients, highlighting the need for a more manageable solution [13][14][15] - **Innovative Delivery**: Utilizes a proprietary capsid for safe, low-dose intravitreal injections, aiming for continuous expression of aflibercept [25][41] - **Market Differentiation**: Positioned as a unique offering in the gene therapy space, distinct from traditional TKIs, with a focus on long-term durability and reduced treatment burden [46][47] Future Catalysts - **Upcoming Milestones**: Expected completion of Phase 3 enrollment for wet AMD in Q1 2026 and DME in Q2 2026, with top-line data anticipated in the first half of 2027 [38][39] - **Financial Outlook**: Strong cash position expected to support ongoing clinical activities and potential commercialization efforts [39]
4D Molecular Therapeutics (NasdaqGS:FDMT) FY Earnings Call Presentation
2026-01-14 15:30
The New Backbone of Retina Care: Moving Beyond Lifelong Injections Corporate Overview J.P. Morgan Healthcare Conference | January 2026 This Presentation shall not constitute an offer to sell or the solicitation of an offer to buy securities. © 2026 4D Molecular Therapeutics. All Rights Reserved. 2 Overview 1 4DMT Vision & Pipeline 2 4D-150 Overview & 2025 Accomplishments 3 Retinal Vascular Disease Market & Unmet Medical Needs 4 Derisking Phase 3 & Commercialization 5 2026-27 Catalysts 6 Summary © 2026 4D Mo ...
4DMT Provides Company Update and Anticipated Development Milestones for 2026
Globenewswire· 2026-01-07 13:00
Core Insights - 4D Molecular Therapeutics (4DMT) is advancing its lead product candidate, 4D-150, aimed at treating retinal vascular diseases, with significant milestones expected in 2026 [1][14] Leadership Changes - Glenn P. Sblendorio has joined the Board of Directors, bringing extensive experience from IVERIC Bio and The Medicines Company, which will support the company's late-stage execution and commercial readiness [3][7] - Katy Barglow, Ph.D., has been promoted to Chief Technical Officer, overseeing the transition to commercial manufacturing [12] - Kim Maplestone has been promoted to Chief Clinical Operations Officer, responsible for global clinical operations [12] - Chris Simms' role has expanded to Chief Commercial & Business Officer, including business development oversight [12] - Fred Kamal, Ph.D., has transitioned to Chief Technical Advisor, supporting CMC and regulatory strategy for 4D-150 [12] Clinical Development Updates - Enrollment in the 4D-150 Phase 3 wet AMD clinical trials is exceeding expectations, with 381 patients randomized or approved to randomize as of January 6, 2026, and completion expected in Q1 2026 [4][5] - The target enrollment for the 4FRONT Global Phase 3 Program has increased from 400 to 480 patients per trial, providing approximately 90% power for regulatory success [5] - Topline data from the 4FRONT-1 trial is expected in H1 2027, while the 4FRONT-2 trial is on track for completion in H2 2026 [5] - 4D-150's Phase 2b data from the PRISM trial is expected to be presented in mid-2026 [4][5] Financial Position - As of December 31, 2025, the company reported $514 million in cash, cash equivalents, and marketable securities, which is expected to fund operations into the second half of 2028 [9] Upcoming Events - The company will present its strategic outlook at the 44th Annual J.P. Morgan Healthcare Conference on January 14, 2026, at 7:30 a.m. PT [10]
Why Everyone Is Watching 4D Molecular Therapeutics, Inc. (FDMT) Closely
Yahoo Finance· 2025-12-27 12:43
Company Overview - 4D Molecular Therapeutics, Inc. (NASDAQ:FDMT) is a California-based late-stage biotechnology company specializing in adeno-associated virus vectors, founded in 2013. The company operates through a proprietary synthetic vector discovery platform known as Therapeutic Vector Evolution [5]. Investment Potential - 4D Molecular Therapeutics, Inc. is considered one of the best stocks for rapid wealth accumulation, with 82% of analysts covering the stock giving it a 'Buy' or equivalent rating. The price target ranges from $17 to $45, with a one-year median price target of $33, indicating an upside potential of over 300% [1]. Clinical Trial Results - On December 17, the company reported positive interim clinical data from its 4D-710 Phase 1 AEROW clinical trial targeting cystic fibrosis lung disease. The higher-dose cohorts showed no new pulmonary or safety events over up to 3.5 years of follow-up, and any unfavorable events related to 4D-710 were mild and resolvable within 2 months in lower-dose cohorts [3]. - Airway biopsy and brushing outcomes indicated stable and dose-dependent CFTR transgene RNA levels at or above physiologically relevant levels compared to non-CF control samples. In the 2.5E14 vg dose cohort, results aligned with the target expression profile, showing meaningful activity across all endpoints, particularly ppFEV1 and LCI2.5 [4]. Insider Activity - On December 19, Scott Bizily, the Chief Legal Officer of 4D Molecular Therapeutics, sold 1,635 shares of the company's stock for approximately $17,821 [2].
4D Molecular Therapeutics: Jury Still Out On CF Gene Therapy After Dense Data Drop (NASDAQ:FDMT)
Seeking Alpha· 2025-12-19 14:00
Group 1 - The article promotes a weekly newsletter focused on stocks in the biotech, pharma, and healthcare industries, highlighting key trends and catalysts that influence market valuations [1] - The newsletter is led by a biotech consultant with over 5 years of experience, who has compiled detailed reports on more than 1,000 companies [1] - The investing group, Haggerston BioHealth, caters to both novice and experienced investors, providing insights on product sales, forecasts for major pharmaceutical companies, and various financial analyses [1]
BlackBerry, FedEx, Nike And Other Big Stocks Moving Lower In Friday's Pre-Market Session
Benzinga· 2025-12-19 13:08
Group 1 - U.S. stock futures were mostly higher, with Nasdaq 100 futures gaining around 100 points [1] - BlackBerry reported third-quarter revenue of $141.8 million, exceeding analyst estimates of $137.4 million [2] - BlackBerry's adjusted earnings were 5 cents per share, beating estimates of 4 cents per share [2] Group 2 - BlackBerry's total revenue decreased approximately 1% year-over-year, while QNX revenue grew by 10% [2] - BlackBerry shares fell 4.6% to $4.13 in pre-market trading [2] - Aimei Health Technology Co Ltd shares dropped 15.8% to $44.00 after a significant increase the previous day [3] - Nike Inc shares decreased 9.9% to $59.11 despite better-than-expected earnings and sales, due to a decline in gross margins [3] - FedEx Corp shares fell 2.2% to $281.00, despite posting strong financial results and raising FY2026 guidance [3]