Workflow
4D Molecular Therapeutics(FDMT)
icon
Search documents
4DMT Provides Company Update and Anticipated Development Milestones for 2026
Globenewswire· 2026-01-07 13:00
Enrollment in 4D-150 Phase 3 wet AMD clinical trials exceeding expectations; 4FRONT-1 trial remains on track to complete enrollment in Q1 2026, with 381 patients randomized or approved to randomize as of January 6, 20264D-150 PRISM wet AMD 2-year Phase 2b data expected mid-20264D-150 DME global Phase 3 trial initiation expected Q3 2026; 2-year SPECTRA Phase 1/2 data expected H2 2026Appointed Glenn Sblendorio to Board of Directors, adding deep commercial and operating experience, including in retina therapeu ...
Why Everyone Is Watching 4D Molecular Therapeutics, Inc. (FDMT) Closely
Yahoo Finance· 2025-12-27 12:43
4D Molecular Therapeutics, Inc. (NASDAQ:FDMT) is among the Best Get Rich Fast Stocks to Buy Right Now. As of December 24, 4D Molecular Therapeutics, Inc. (NASDAQ:FDMT) has a ‘Buy’ or equivalent rating from 82% of the analysts covering the stock. While the price target ranges from $17 to $45, the one-year median price target of $33 translates to an upside potential of over 300%. On December 19, Scott Bizily, the CLO of 4D Molecular Therapeutics, Inc. (NASDAQ:FDMT), offloaded 1,635 shares of the company’s s ...
4D Molecular Therapeutics: Jury Still Out On CF Gene Therapy After Dense Data Drop (NASDAQ:FDMT)
Seeking Alpha· 2025-12-19 14:00
If you are interested in keeping up to date with stocks making moves within the biotech, pharma and healthcare industries, and understanding the key trends and catalysts driving valuations ahead of the market, why not subscribe to my weekly newsletter via my Investing Group, Haggerston BioHealth ?Edmund Ingham is a biotech consultant. He has been covering biotech, healthcare, and pharma for over 5 years, and has put together detailed reports of over 1,000 companies. He leads the investing group Haggerston B ...
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]
4D Molecular Therapeutics, Inc. (FDMT) Discusses Interim Phase I Data From AEROW Trial in Cystic Fibrosis and Platform Potential Transcript
Seeking Alpha· 2025-12-17 17:59
PresentationWith that, I will hand the call over to Julian Pei, Head of Investor Relations, who will make introductory comments.Hello, ladies and gentlemen. Thank you for standing by, and welcome to our investor webcast today. As a reminder, today's call is being recorded.Julian Pei Good morning, and thank you for joining our webcast to discuss interim Phase I data from our AEROW trial in cystic fibrosis. Before we begin, I encourage everyone to visit our Investor Relations website, where you can find a pre ...
4D Molecular Therapeutics (NasdaqGS:FDMT) Update / Briefing Transcript
2025-12-17 14:02
Summary of 4D Molecular Therapeutics Conference Call Company Overview - **Company**: 4D Molecular Therapeutics (NasdaqGS:FDMT) - **Focus**: Development of gene therapy for cystic fibrosis (CF) using AAV vectors Industry Context - **Cystic Fibrosis**: A genetic disorder affecting over 100,000 people globally, with a significant unmet need for effective therapies - **Current Treatments**: Existing modulators have improved outcomes for some patients, but many remain without effective options Key Points and Arguments Gene Therapy Development - **Need for Effective Gene Delivery**: The company emphasizes the urgent need for effective AAV vectors for gene delivery in CF, as previous attempts have failed due to ineffective delivery and expression [2][3] - **AAV Vector Technology**: Utilizes a novel AAV vector (A101) designed to penetrate mucus, transduce all airway cell types, and resist pre-existing immunity [2] - **Administration Method**: The therapy (4D-710) is administered via the FDA-approved AeroEclipse II nebulizer, ensuring widespread delivery throughout the airways [2] Clinical Trial Design and Results - **Phase 1 Trial Focus**: The trial aimed to find the optimal dose for safety and CFTR expression levels, with a focus on dose-finding and safety assessments [4][5] - **Dose Ranging**: Initial doses started at 1 x 10^15 vector genomes, with adjustments made based on safety and expression data [5] - **Safety Profile**: The lower dose (2.5 x 10^14 vector genomes) showed excellent safety and tolerability, with no significant adverse events beyond day 14 [8][9] Clinical Activity and Efficacy - **Endpoints**: The trial included multiple endpoints such as FEV1, Lung Clearance Index (LCI), and quality of life measures [18][31] - **Improvements Observed**: Participants receiving the selected lower dose showed greater improvements in clinical endpoints compared to those on higher doses [26][30] - **Durability of Expression**: Data indicated that the AAV-based approach could deliver durable CFTR expression for one to three years, supporting the decision to proceed with the selected dose in phase 2 [32][34] Regulatory Considerations - **FDA Engagement**: The company has had productive discussions with the FDA regarding the use of LCI as a primary efficacy endpoint, especially in pediatric studies [42][46] - **Future Plans**: The company plans to leverage data from ongoing studies to inform future regulatory submissions and potential accelerated approval pathways [66] Financial and Strategic Outlook - **Funding**: The program is fully funded by the Cystic Fibrosis Foundation, alleviating financial pressure on the company [53] - **Partnership Potential**: The company is open to future partnerships but aims to retain rights until more data is available [72] Additional Important Insights - **Patient Variability**: The variability in patient responses highlights the need for a diverse participant pool in future trials [39][41] - **Redosing Strategy**: The company anticipates a redosing interval of 12 to 18 months based on durability data, with LCI serving as a leading indicator for treatment effect [80] This summary encapsulates the critical aspects of the conference call, focusing on the company's innovative approach to treating cystic fibrosis through gene therapy and the ongoing clinical development of its lead product, 4D-710.
4D Molecular Therapeutics (NasdaqGS:FDMT) Update / Briefing Transcript
2025-12-17 14:02
4D Molecular Therapeutics (NasdaqGS:FDMT) Update / Briefing December 17, 2025 08:00 AM ET Company ParticipantsJulian Pei - Head of Investor RelationsDaniel Giraldo - VP of Equity ResearchFelix Ratjen - Paediatric RespirologistJonathan Miller - Managing Director of Biotech and Pharma Equity ResearchJennifer Taylor Cousar - Professor of Internal Medicine and PediatricsGena Wang - Managing Director of Biotech Equity ResearchRyan McElroy - Equity Research AssociateDavid Kirn - Founder and CEOConference Call Par ...
4D Molecular Therapeutics (NasdaqGS:FDMT) Earnings Call Presentation
2025-12-17 13:00
4D-710 Phase 1 Interim Data Key Takeaways - 4D-710 was well-tolerated with 4 to 24 months follow-up[14] - 4D-710 demonstrated clinically meaningful activity in lung function (FEV1, LCI2.5) and quality-of-life (CFQ-R-R)[14] - 4D-710 has durable CFTR transgene expression through at least 1 year[14] - Phase 2 enrollment is underway at Cohort 4 dose level[14] Cystic Fibrosis (CF) Market & 4D-710 Design - The CFTR modulator market size is approximately $11 billion in 2024[17] - 4D-710 is designed as a durable, redosable, variant-agnostic, disease-modifying therapy for CF lung disease[30] - 4D-710 utilizes aerosol delivery of a novel A101 vector invented with directed evolution[25] - The A101 vector enhances transduction of airway cells and overcomes potential barriers[26] Clinical Trial Results & Next Steps - In the Phase 1 trial, the 2.5E14 vg dose (Cohort 4) met the target expression profile of approximately 10-25% airway cells for CFTR RNA[63] - Durable expression of CFTR was observed with levels consistent with non-CF samples over 1 year[142] - The Cystic Fibrosis Foundation (CFF) has provided approximately $31 million in financial support for 4D-710 development[146] - The company expects to complete Phase 2 enrollment in H1 2026 and provide a program update in H2 2026[152]
4DMT Announces Positive Interim Clinical Data from 4D-710 AEROW Phase 1 Clinical Trial in Cystic Fibrosis Lung Disease
Globenewswire· 2025-12-17 12:00
Clinically meaningful lung function activity, measured by ppFEV1 and LCI2.5, with follow-up through 1 year at dose selected for Phase 2 Durable CFTR transgene expression within target therapeutic range with follow-up through at least 1 year Data support 4D-710’s potential to be a durable, redosable, variant-agnostic, disease-modifying treatment for people with cystic fibrosis lung disease with high unmet needWebcast today at 8:00 a.m. ET with distinguished cystic fibrosis KOLs EMERYVILLE, Calif., Dec. 17, 2 ...
4DMT to Present at the 44th Annual J.P. Morgan Healthcare Conference
Globenewswire· 2025-12-08 13:00
Core Viewpoint - 4D Molecular Therapeutics is a late-stage biotechnology company focused on developing durable and disease-targeted therapeutics that aim to transform treatment paradigms and provide significant benefits to patients [1][3]. Group 1: Company Overview - 4DMT's lead product candidate, 4D-150, is designed to treat blinding retinal vascular diseases through multi-year sustained delivery of anti-VEGF with a single intravitreal injection, reducing the treatment burden associated with current methods [3]. - The primary indication for 4D-150 is wet age-related macular degeneration, which is currently in Phase 3 development, while the second indication is diabetic macular edema [3]. - The second product candidate, 4D-710, is the first genetic medicine to successfully deliver and express the CFTR transgene in the lungs of cystic fibrosis patients via aerosol delivery [3]. Group 2: Upcoming Events - 4D Molecular Therapeutics will present at the 44th Annual J.P. Morgan Healthcare Conference on January 14, 2026, at 7:30 a.m. PT [2]. - A webcast of the presentation will be available for one year on the company's investor relations website [2].