other material
confidence high
sentiment negative
materiality 0.85
4DMT reports pipeline progress; Fabry trial halted after aHUS, FDA aligns on endpoints
4D Molecular Therapeutics, Inc.
- Filed IND for Phase 2 SPECTRA trial of 4D-150 in DME; enrollment expected Q3 2023.
- Initiated randomized Phase 2 PRISM trial in wet AMD; 50 patients, 2:2:1 vs aflibercept.
- Fabry program: 3 aHUS cases among 6 patients; one grade 4 DLT requiring hemodialysis.
- Cardiac efficacy promising: improvements in peak VO2, KCCQ, GLS in evaluable patients.
- FDA aligned on pivotal endpoints (peak VO2, KCCQ); co. halts enrollment, will re-evaluate in H2 2023.