secwatch.observer — SEC 8-K summary
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Issuer:     4D Molecular Therapeutics, Inc. (FDMT)
CIK:        0001650648
Form:       8-K
Filed at:   2025-12-10T23:59:59+00:00
Accession:  0001193125-25-314167
Event type: other_material
Sentiment:  neutral
Materiality: 0.65
Item codes: 8.01
LLM model:  deepseek-v4-flash:cloud@v2

4D Molecular Therapeutics increases wet AMD trial enrollment to 480 patients for global regulatory submissions
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- Target enrollment for 4FRONT-1 and 4FRONT-2 Phase 3 trials raised from 400 to 480 patients each.
- Amendments aim for ~90% power with ~4-letter noninferiority margin for non-FDA agencies (e.g., PMDA, EMA).
- No impact on guided enrollment completion or financial runway into H2 2028; 4FRONT-1 topline expected H1 2027.
- Asia-Pacific regulatory submissions supported by Otsuka partnership, leveraging global commercial opportunity.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1650648/000119312525314167/0001193125-25-314167-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1650648/000119312525314167/fdmt-20251210.htm
  HTML page:      https://secwatch.observer/filing/0001193125-25-314167

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