---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-23-023004"
form_type: "8-K"
ticker: "FDMT"
cik: "0001650648"
company_name: "4D Molecular Therapeutics, Inc."
filed_at: "2023-02-03T23:59:59+00:00"
generated_at: "2026-06-20T01:08:43.853244+00:00"
event_type: "regulatory"
sentiment: "negative"
materiality_score: 0.8
calibrated_materiality_score: 0.8
confidence: "high"
source: SEC EDGAR
---

# FDA clears IND for 4D-150 DME trial; places clinical hold on 4D-310 Fabry program after aHUS cases

## Summary
- 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.

## SEC filing metadata
- accession: 0001193125-23-023004
- form_type: 8-K
- ticker: FDMT
- cik: 0001650648
- company_name: 4D Molecular Therapeutics, Inc.
- filed_at: 2023-02-03T23:59:59+00:00
- event_type: regulatory
- sentiment: negative
- materiality_score: 0.8
- calibrated_materiality_score: 0.8
- confidence: high
- sec_items: 8.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1650648/000119312523023004/0001193125-23-023004-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1650648/000119312523023004/d435190d8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-23-023004
- JSON: https://secwatch.observer/filing/0001193125-23-023004.json
- Plain text: https://secwatch.observer/filing/0001193125-23-023004.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.