secwatch.observer — SEC 8-K summary
======================================

Issuer:     4D Molecular Therapeutics, Inc. (FDMT)
CIK:        0001650648
Form:       8-K
Filed at:   2023-02-03T23:59:59+00:00
Accession:  0001193125-23-023004
Event type: regulatory
Sentiment:  negative
Materiality: 0.80
Item codes: 8.01
LLM model:  deepseek-v4-flash:cloud@v2

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

- 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.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1650648/000119312523023004/0001193125-23-023004-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1650648/000119312523023004/d435190d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-23-023004

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer