#FDMT

StockTitan

@stocktitan.net

2 months ago

4DMT Provides Company Update and Anticipated Development Milestones for 2026 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, 2026 4D-150 PRISM wet AMD 2-year Phase 2b data expected mid-2026 4D-150 DME global

#FDMT 4DMT Provides Company Update and Anticipated Development Milestones for 2026

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StockTitan

@stocktitan.net

2 months ago

4DMT Announces Positive Interim Clinical Data from 4D-710 AEROW Phase 1 Clinical Trial in Cystic Fibrosis Lung Disease Clinically meaningful lung function activity, measured by ppFEV 1 and LCI 2.5 , 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,

#FDMT 4DMT Announces Positive Interim Clinical Data from 4D-710 AEROW Phase 1 Clinical Trial in Cystic Fibrosis Lung Disease

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StockTitan

@stocktitan.net

4 months ago

#FDMT 4DMT Reports Third Quarter 2025 Financial Results, Operational Highlights and Expected Upcoming Milestones

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StockTitan

@stocktitan.net

4 months ago

4DMT Announces Pricing of $100 Million Offering of Common Stock and Pre-Funded Warrants 4D Molecular Therapeutics (Nasdaq: FDMT) priced an underwritten common stock offering to raise approximately $100 million gross. The company will sell 8,385,809 common shares at $10.51 per share and, in lieu of shares for certain investors, 1,128,949 pre-funded warrants at $10.5099 each (exercise price $0.0001).The offering is expected to close on November 7, 2025, subject to customary closing conditions; gross proceeds are before underwriting discounts, commissions and offering expenses. Leerink Partners, Evercore ISI and Cantor are joint book-running managers; RBC Capital Markets is co-manager.

#FDMT 4DMT Announces Pricing of $100 Million Offering of Common Stock and Pre-Funded Warrants

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StockTitan

@stocktitan.net

4 months ago

4DMT Announces Exclusive License Agreement with Otsuka Pharmaceutical Co., Ltd. for Development and Commercialization of 4D-150 in Asia-Pacific 4DMT (Nasdaq: FDMT) entered an exclusive license agreement with Otsuka to develop and commercialize 4D-150 for wet AMD and DME across the greater Asia-Pacific region, including Japan.Key terms include an $85 million upfront cash payment, an expected ≥$50 million of cost sharing over three years for global development, up to $336 million in regulatory and commercial milestones, and tiered double-digit royalties on net sales in Otsuka’s territories. 4DMT retains development and commercialization rights outside APAC and will continue to lead global Phase 3 activities; APAC sites for 4FRONT-2 are expected to open by year-end, with Japan sites expected in January 2026.

#FDMT 4DMT Announces Exclusive License Agreement with Otsuka Pharmaceutical Co., Ltd. for Development and Commercialization of 4D-150 in Asia-Pacific

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StockTitan

@stocktitan.net

5 months ago

4DMT Advances 4D-710 to Phase 2 with Additional Funding and Support from the Cystic Fibrosis Foundation Cystic Fibrosis Foundation to provide up to $11 million in additional funding to accelerate development of 4D-710 for cystic fibrosis, following program and clinical data review by its independent scientific advisors Funding supports second 4D-710 dosing ≥1 year post initial Phase 1 dose,

#FDMT 4DMT Advances 4D-710 to Phase 2 with Additional Funding and Support from the Cystic Fibrosis Foundation

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Kulturdesken

@kulturdesken.bsky.social

5 months ago

#FDMT did smaller size as I realized I was getting sloppy. Several mistakes last few days.

Also didn't have to to prepare scans so I missed that biotech sector was clearly setting up.

Weekend work is super important.

StockTitan

@stocktitan.net

6 months ago

4DMT Announces Leadership Expansion with Proven Late-Stage Executives to Drive 4D-150 Execution and BLA Readiness 4D Molecular Therapeutics (NASDAQ: FDMT) announced key leadership changes to strengthen its late-stage clinical development capabilities. Dr. Julie Clark has been promoted to Chief Medical Officer, bringing over 20 years of retina and clinical development experience, including involvement in 10 BLA-enabling studies and six Phase 3 trials. The company also welcomed Dr. Liansheng Zhu as SVP of Biometrics and Data Quality.The company's 4FRONT-1 Phase 3 trial for 4D-150 is progressing ahead of schedule, with enrollment completion expected in Q1 2026. Additionally, FDMT has added distinguished retina industry advisors, including Glenn P. Sblendorio, Dr. Cal Roberts, and Dr. Wiley A. Chambers, to enhance their development and commercialization expertise. Dr. Robert Kim has stepped down as Chief Medical Officer.

#FDMT 4DMT Announces Leadership Expansion with Proven Late-Stage Executives to Drive 4D-150 Execution and BLA Readiness

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StockTitan

@stocktitan.net

7 months ago

4DMT Reports Second Quarter 2025 Financial Results, Operational Highlights and Expected Upcoming Milestones 4D Molecular Therapeutics (NASDAQ:FDMT) reported Q2 2025 financial results and operational updates, highlighting significant progress in its clinical programs. The company announced an accelerated timeline for its 4D-150 Phase 3 program in wet AMD, with 4FRONT-1 data now expected in H1 2027. Additionally, positive 60-week results were presented from the 4D-150 SPECTRA trial in DME.Key financial metrics include $417 million in cash as of June 30, 2025, expected to fund operations into 2028. Q2 2025 saw R&D expenses of $48.0 million and a net loss of $54.7 million. The company implemented a 25% workforce reduction, expected to generate annual savings of $15 million.Clinical progress includes strong enrollment in the 4FRONT-1 trial, early initiation of 4FRONT-2, and positive DME trial results showing favorable tolerability and sustained durability. Both FDA and EMA indicated that a single successful Phase 3 study could support approval in the U.S. and Europe.

#FDMT 4DMT Reports Second Quarter 2025 Financial Results, Operational Highlights and Expected Upcoming Milestones

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StockTitan

@stocktitan.net

7 months ago

Breakthrough: 4D-150 DME Treatment Shows 78% Reduction in Injections, FDA and EMA Clear Path to Approval Phase 3 dose demonstrates 78% fewer injections vs standard treatment, plus sustained vision gains. FDA and EMA support accelerated approval pathway. See full results.

#FDMT 4DMT Presents Positive 60-Week Results from 4D-150 SPECTRA Clinical Trial in DME and Regulatory Update

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StockTitan

@stocktitan.net

7 months ago

4DMT Reveals New Phase 2 Trial Results for Revolutionary Eye Disease Treatment at Major Conference Latest clinical data from two Phase 2 trials for diabetic eye disease and macular degeneration treatments to be presented. Key efficacy results coming. Learn more.

#FDMT 4DMT Announces Presentations at 43rd Annual Scientific Meeting of the American Society of Retina Specialists

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Small Cap Strategist

@smcapstrategist.bsky.social

8 months ago

Small-cap stocks with declining money flow, Tue Jul 8th - #ULCC #RAPT #PRTA #MRKR #LTBR #KIRK #IKNA #GLRE #FDMT #EVAX #ONTH #STAA #TVNA #BLFS #BRCP #AYTU #ZEPP #VLRS #SEMR #OBK #LUXE #HBI #CHCG #REPL - More: crystalequityresearch.com/SmCpStr/ - #smallcap

StockTitan

@stocktitan.net

8 months ago

4DMT Announces Accelerated 4D-150 Phase 3 Development in Wet AMD and Streamlined Organization to Drive Late-Stage Execution 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.

#FDMT 4DMT Announces Accelerated 4D-150 Phase 3 Development in Wet AMD and Streamlined Organization to Drive Late-Stage Execution

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StockTitan

@stocktitan.net

10 months ago

4DMT Reports First Quarter 2025 Financial Results, Operational Highlights and Expected Upcoming Milestones 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.

#FDMT 4DMT Reports First Quarter 2025 Financial Results, Operational Highlights and Expected Upcoming Milestones

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StockTitan

@stocktitan.net

10 months ago

4DMT Announces RMAT Designation Granted by FDA for 4D-150 for DME 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.

#FDMT 4DMT Announces RMAT Designation Granted by FDA for 4D-150 for DME

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StockTitan

@stocktitan.net

1 year ago

4DMT Announces First Patients Enrolled in 4FRONT-1 Phase 3 Clinical Trial Evaluating 4D-150 in Wet AMD 4D Molecular Therapeutics (FDMT) has announced the enrollment of first patients in its 4FRONT-1 Phase 3 clinical trial evaluating 4D-150 for wet age-related macular degeneration (wet AMD) treatment. The trial is a multicenter, randomized, double-masked study comparing 4D-150 with aflibercept 2 mg.The primary endpoint aims to demonstrate non-inferiority in mean change from baseline in best corrected visual acuity at 52 weeks. A key secondary endpoint focuses on reducing treatment burden by comparing the number of aflibercept injections between treatment arms.The company plans to initiate 4FRONT-2, a second Phase 3 trial with identical design, in Q3 2025. Topline primary endpoint data from both trials is expected in the second half of 2027. The treatment aims to address the challenge of frequent eye injections while preserving eyesight for millions of wet AMD patients.

#FDMT 4DMT Announces First Patients Enrolled in 4FRONT-1 Phase 3 Clinical Trial Evaluating 4D-150 in Wet AMD

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StockTitan

@stocktitan.net

1 year ago

4DMT Reports Full Year 2024 Financial Results, Operational Highlights and Expected Upcoming Milestones 4D Molecular Therapeutics (FDMT) reported its full year 2024 financial results with significant progress in its clinical programs. The company highlighted positive interim data for 4D-150 in wet AMD and DME treatments, showing robust clinical activity and durability.Key financial metrics include $505 million in cash and equivalents as of December 31, 2024, expected to fund operations into 2028. The company reported a net loss of $160.9 million for 2024, compared to $100.8 million in 2023. R&D expenses increased to $141.3 million from $97.1 million in 2023.The company plans to initiate Phase 3 trials (4FRONT-1 and 4FRONT-2) for wet AMD in March and Q3 2025 respectively, with topline data expected in H2 2027. FDA alignment was achieved for a single Phase 3 trial for DME treatment.

#FDMT 4DMT Reports Full Year 2024 Financial Results, Operational Highlights and Expected Upcoming Milestones

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Thiard News@F4F

@newsen.bsky.social

1 year ago

Pomerantz Law Firm Launches Investigation Into 4D Molecular Therapeutics for Investor Claims Pomerantz LLP investigates claims regarding 4D Molecular Therapeutics, potentially involving securities fraud and business misconduct. Contact for details.

Pomerantz Law Firm Launches Investigation Into 4D Molecular Therapeutics for Investor Claims #United_States #New_York #Pomerantz_LLP #4D_Molecular #FDMT

StockTitan

@stocktitan.net

1 year ago

Revolutionary AMD Treatment Cuts Eye Injections by 83% - 4D Molecular's Game-Changing Phase 2b Results 4D Molecular's 4D-150 achieves 83% reduction in eye injection burden with 70% of wet AMD patients needing 0-1 supplemental treatments over 52 weeks.

#FDMT 4DMT Presents Positive 52-Week Results from Phase 2b Cohort of PRISM Wet AMD Study and Long-term Durability Data Supporting 4D-150 4FRONT Global Registration Program

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StockTitan

@stocktitan.net

1 year ago

Breakthrough Eye Treatment Data: 4D Molecular's AMD Trial Results Coming February 4D Molecular announces webcast to reveal important 52-week Phase 2b trial data for 4D-150 in wet AMD patients, featuring expert insights and comprehensive efficacy analysis.

#FDMT 4DMT Announces Corporate Webcast to Review Interim 52-week Results from the Phase 2b Cohort of PRISM in a Broad Wet AMD Population

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Thiard News@F4F

@newsen.bsky.social

1 year ago

Pomerantz Law Firm Launches Investigation into 4D Molecular Therapeutics, Inc. for Potential Securities Fraud Pomerantz LLP is looking into potential securities fraud involving 4D Molecular Therapeutics, Inc., following a downgrade by BMO Capital Markets.

Pomerantz Law Firm Launches Investigation into 4D Molecular Therapeutics, Inc. for Potential Securities Fraud #United_States #New_York #Pomerantz_Law #4D_Molecular #FDMT

StockTitan

@stocktitan.net

1 year ago

4D Molecular's DME Drug Shows 86% Injection Reduction, Strong Vision Gains in Clinical Trial 4D-150 demonstrates significant vision improvement and reduced treatment burden in diabetic macular edema trial. FDA agrees to streamlined Phase 3 pathway for potential approval.

#FDMT 4DMT Announces Positive Interim Data from 4D-150 SPECTRA Clinical Trial in DME and Alignment with FDA on Registrational Path

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StockTitan

@stocktitan.net

1 year ago

4D Molecular Therapeutics Streamlines Pipeline, Advances Key Eye Disease & CF Programs with $506M Cash 4D Molecular focuses on 4D-150 for wet AMD/DME and 4D-710 for cystic fibrosis, securing FDA/EMA alignment for Phase 3 trials. $506M cash extends operations to 2028.

#FDMT 4DMT Focuses Pipeline to Prioritize 4D-150 in Wet AMD & DME and 4D-710 in CF and Extends Cash Runway

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StockTitan

@stocktitan.net

1 year ago

4D Molecular's R100 Vector Shows 10X Potency Breakthrough in Landmark Eye Disease Study Groundbreaking preclinical data reveals 4D Molecular's R100 vector outperforms standard treatments by 10-fold in retinal cells, advancing novel gene therapy for eye diseases.

#FDMT 4DMT Announces Landmark Publication of 4D-150 Preclinical Data for the Treatment of Neovascular Retinopathies in IOVS

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StockTitan

@stocktitan.net

1 year ago

#FDMT 4DMT to Participate in Upcoming Investor Conferences and Ophthalmology Innovation Summit XIV

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StockTitan

@stocktitan.net

1 year ago

#FDMT 4DMT Reports Third Quarter 2024 Financial Results, Operational Highlights and Expected Upcoming Milestones

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InsiderFinance

@insiderfinance.com

1 year ago

🎯 #UnusualOptionsActivity trade ideas! Strong census from institutions on #options with short expirations.

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InsiderFinance

@insiderfinance.com

1 year ago

🎯 #UnusualOptionsActivity trade ideas! Strong census from institutions on #options with short expirations.

AM Algo #TradeIdea from 🔥 INSIDERFINANCE.COM 🔥
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InsiderFinance

@insiderfinance.com

1 year ago

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AM Top Unusual Activity from 🔥 INSIDERFINANCE.COM 🔥
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