---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-23-016298"
form_type: "8-K"
ticker: "FDMT"
cik: "0001650648"
company_name: "4D Molecular Therapeutics, Inc."
filed_at: "2023-01-26T23:59:59+00:00"
generated_at: "2026-06-20T08:16:27.949743+00:00"
event_type: "other_material"
sentiment: "negative"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# 4DMT reports pipeline progress; Fabry trial halted after aHUS, FDA aligns on endpoints

## Summary
- 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.

## SEC filing metadata
- accession: 0001193125-23-016298
- form_type: 8-K
- ticker: FDMT
- cik: 0001650648
- company_name: 4D Molecular Therapeutics, Inc.
- filed_at: 2023-01-26T23:59:59+00:00
- event_type: other_material
- sentiment: negative
- materiality_score: 0.85
- calibrated_materiality_score: 0.85
- confidence: high
- sec_items: 8.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1650648/000119312523016298/0001193125-23-016298-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1650648/000119312523016298/d427358d8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-23-016298
- JSON: https://secwatch.observer/filing/0001193125-23-016298.json
- Plain text: https://secwatch.observer/filing/0001193125-23-016298.txt

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