4D Molecular Therapeutics(FDMT)
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4D Molecular Therapeutics, Inc. (FDMT) Special Call Transcript
Seeking Alpha· 2024-07-18 03:38
4D Molecular Therapeutics, Inc. (NASDAQ:FDMT) Special Call July 17, 2024 6:30 AM ET Company Participants Uneek Mehra - Chief Financial and Business Officer David Kirn - Chief Executive Officer and Co-Founder Robert Kim - Chief Medical Officer Arshad Khanani - Lead Investigator of PRISM Clinical Trial, Sierra Eye Associates Conference Call Participants Salveen Richter - Goldman Sachs Tazeen Ahmad - BofA Securities Jonathan Miller - Evercore ISI Gena Wang - Barclays Clara Dong - Jefferies Operator Ladies and ...
4DMT Announces Positive Phase 2 PRISM Interim Results for Intravitreal 4D-150 in a Broad Wet AMD Population Affirming Favorable Safety Profile and Robust Clinical Activity
Newsfilter· 2024-07-17 17:00
Robust reduction in anti-VEGF injection treatment burden through Week 24 achieved in 30 patients at planned Phase 3 dose (3E10 vg/eye) with 89% reduction in annualized injection rate; 93% of patients received 0 or 1 injection and 77% were injection-freeImprovement in mean best corrected visual acuity (BCVA) from baseline through Week 24 achieved at 3E10 vg/eye dose (+4.2 letters); dose response in favor of 3E10 vg/eye dose demonstrated (+5.7 letters vs low dose)3E10 vg/eye dose demonstrated sustained and gr ...
4D Molecular Therapeutics (FDMT) Moves 11.1% Higher: Will This Strength Last?
ZACKS· 2024-07-12 22:41
4D Molecular Therapeutics, Inc. (FDMT) shares soared 11.1% in the last trading session to close at $25.79. The move was backed by solid volume with far more shares changing hands than in a normal session. This compares to the stock's 3.6% loss over the past four weeks. Investors are bullish on the stock due to the recent pipeline progress. Last month, the FDA cleared the company's investigational new drug application or 4D-175, an R100 vector-based intravitreal genetic medicine, for the treatment of patient ...
4DMT Announces FDA Clearance of IND Application for 4D-175 Genetic Medicine for the Treatment of Geographic Atrophy
Newsfilter· 2024-06-24 20:00
4D-175 comprises the proprietary low-dose intravitreal R100 AAV vector and a codon-optimized transgene encoding a highly functional shortened form of human complement factor H (sCFH) Complement factor H (CFH) variants with reduced function are a well-validated genetic risk factor for geographic atrophy (GA), with approximately 75% of age-related macular degeneration (AMD) patients carrying a high-risk variant of CFH Over 150 patients have been treated with the R100 vector, including those with wet AMD and d ...
4DMT to Present Initial Interim 24-week Landmark Analysis from the 4D-150 Phase 2 PRISM Population Extension Cohort in a Broad Wet AMD Population at ASRS and Host a Corporate Webcast
Newsfilter· 2024-06-18 20:00
24-week landmark safety and clinical activity data for 45 patients enrolled in the Population Extension cohort expected to be presented (N=30 at 3E10 vg/eye) Clinical data will be presented by Raj K. Maturi, M.D., a Principal Investigator in the PRISM study, at the American Society of Retina Specialists (ASRS) Annual Scientific Meeting on July 17, 2024 at 8:49 a.m. CEST Company to provide a high-level safety update on 4D-150 treated patients from PRISM and SPECTRA studies (N=139) Company to host webcast on ...
4DMT Presents Injection-Free Subgroup Analyses from 4D-150 Phase 2 PRISM Randomized Dose Expansion Cohort in Wet AMD Patients with Severe Disease Activity & High Treatment Burden at the Clinical Trials at the Summit 2024 Meeting
Newsfilter· 2024-06-09 04:30
Injection-free subgroup results demonstrated that a single intravitreal dose of 4D-150 without any supplemental anti-VEGF injections resulted in stable mean visual acuity that was equal to or higher than in the standard bimonthly aflibercept control group at all six timepoints through Week 24 Single intravitreal 3E10 vg/eye dose resulted in sustained reduction and stabilization of mean central subfield thickness (CST) compared to aflibercept at all timepoints In the 3E10 vg/eye injection-free subgroup, the ...
4DMT Presents Positive Interim Data from Phase 1/2 AEROW Clinical Trial of Aerosolized 4D-710 for Modulator-Ineligible/-Intolerant Cystic Fibrosis at 47th European Cystic Fibrosis Conference
Newsfilter· 2024-06-06 19:30
Clinically meaningful improvements in ppFEV1 at 12 months observed in 2 of 3 participants with mild to moderate baseline lung function impairment (ppFEV1 50-80%) and >6 months follow up Aerosolized 4D-710 was well tolerated at doses up to 1E15 vg (n=6) Dose-dependent and widespread 4D-710-mediated CFTR transgene RNA and protein expression observed in all lung biopsies from all participants evaluated to date Pre-existing AAV immunity cross-reactive with A101 did not affect transgene expression, biological ac ...
4DMT Presents Positive Interim Data from Phase 1/2 AEROW Clinical Trial of Aerosolized 4D-710 for Modulator-Ineligible/-Intolerant Cystic Fibrosis at 47th European Cystic Fibrosis Conference
GlobeNewswire News Room· 2024-06-06 19:30
Clinically meaningful improvements in ppFEV1 at 12 months observed in 2 of 3 participants with mild to moderate baseline lung function impairment (ppFEV1 50-80%) and >6 months follow up Aerosolized 4D-710 was well tolerated at doses up to 1E15 vg (n=6) Dose-dependent and widespread 4D-710-mediated CFTR transgene RNA and protein expression observed in all lung biopsies from all participants evaluated to date Pre-existing AAV immunity cross-reactive with A101 did not affect transgene expression, biological ac ...
4D Molecular Therapeutics(FDMT) - 2024 Q1 - Quarterly Results
2024-05-10 04:22
Exhibit 99.1 4DMT Reports First Quarter 2024 Financial Results and Operational Highlights • Announced positive interim data from PRISM Phase 2 Dose Expansion cohort evaluating 4D-150 in wet AMD patients with severe disease activity and high treatment burden enabling advancement into Phase 3 expected by Q1 2025 • Interim 24-week landmark analysis from PRISM Phase 2 Population Extension cohort evaluating 4D-150 in broader wet AMD population expected to be presented at the American Society of Retina Specialist ...
4D Molecular Therapeutics(FDMT) - 2024 Q1 - Quarterly Report
2024-05-10 04:09
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO Commission File Number 001-39782 4D Molecular Therapeutics, Inc. (Exact name of registrant as specified in its Charter) Delaware 47-3506994 (State or other ...