secwatch.observer — SEC 8-K summary
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Issuer:     Aldeyra Therapeutics, Inc. (ALDX)
CIK:        0001341235
Form:       8-K
Filed at:   2025-12-16T23:59:59+00:00
Accession:  0001193125-25-319638
Event type: regulatory
Sentiment:  negative
Materiality: 0.80
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Aldeyra: FDA extends reproxalap PDUFA to March 16, 2026 after requesting failed trial report
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- PDUFA target action date extended three months to March 16, 2026 from original Dec 16, 2025.
- FDA requested CSR of dry eye field trial that missed primary endpoint; CSR submitted Dec 12 as major amendment.
- FDA shared draft label in early December; Aldeyra responded; labeling and postmarketing plans expected by Feb 16, 2026.
- No other specific issues or requests identified by FDA during review.
- Field trial top-line results announced May 5, 2025; safety data previously submitted Aug 21, 2025.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1341235/000119312525319638/0001193125-25-319638-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1341235/000119312525319638/aldx-20251215.htm
  HTML page:      https://secwatch.observer/filing/0001193125-25-319638

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