secwatch.observer — SEC 8-K summary
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Issuer:     4D Molecular Therapeutics, Inc. (FDMT)
CIK:        0001650648
Form:       8-K
Filed at:   2023-01-26T23:59:59+00:00
Accession:  0001193125-23-016298
Event type: other_material
Sentiment:  negative
Materiality: 0.85
Item codes: 8.01
LLM model:  deepseek-v4-flash:cloud@v2

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

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1650648/000119312523016298/0001193125-23-016298-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1650648/000119312523016298/d427358d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-23-016298

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