secwatch.observer — SEC 8-K summary
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Issuer:     Aldeyra Therapeutics, Inc. (ALDX)
CIK:        0001341235
Form:       8-K
Filed at:   2024-11-18T23:59:59+00:00
Accession:  0001213900-24-099333
Event type: regulatory
Sentiment:  positive
Materiality: 0.80
Item codes: 1.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Aldeyra's reproxalap NDA accepted by FDA with April 2, 2025 PDUFA; expands AbbVie option deal
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- FDA accepted resubmitted NDA for reproxalap for dry eye disease; PDUFA date April 2, 2025.
- Expanded option with AbbVie: upon exercise, AbbVie pays $100M upfront (less $6M fees) plus up to $300M milestones.
- If option exercised, profit/loss split 60% AbbVie, 40% Aldeyra; Aldeyra pre-commercial costs 60% reimbursed by AbbVie.
- Option exercise period amended to 10 business days after FDA approval of reproxalap for dry eye disease.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1341235/000121390024099333/0001213900-24-099333-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1341235/000121390024099333/ea0221568-8k_aldeyra.htm
  HTML page:      https://secwatch.observer/filing/0001213900-24-099333

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