regulatory
confidence high
sentiment negative
materiality 0.80
FDA clears IND for 4D-150 DME trial; places clinical hold on 4D-310 Fabry program after aHUS cases
4D Molecular Therapeutics, Inc.
- FDA cleared IND for 4D-150 in diabetic macular edema; Phase 2 SPECTRA trial enrollment expected Q3 2023.
- Initial 4D-150 wet AMD data showed >95% reduction in annualized anti-VEGF injections; Phase 2 PRISM enrolling.
- 4D-310 Fabry program placed on clinical hold by FDA after 3 atypical hemolytic uremic syndrome cases; no new enrollment.
- Improvements in cardiac endpoints observed in 3 of 6 4D-310 patients at 12 months; FDA allows long-term follow-up.