secwatch.observer — SEC 8-K summary
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Issuer:     Aldeyra Therapeutics, Inc. (ALDX)
CIK:        0001341235
Form:       8-K
Filed at:   2023-03-09T23:59:59+00:00
Accession:  0001157523-23-000419
Event type: earnings
Sentiment:  positive
Materiality: 0.80
Item codes: 2.02, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Aldeyra posts FY2022 net loss $62.0M, cash $174.3M; two NDAs under FDA review with PDUFA dates June and Nov 2023
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- Net loss $62.0M ($1.06/share) vs $57.8M ($1.07/share) in 2021; R&D $47.3M, G&A $15.4M.
- Cash $174.3M at Dec 31, 2022; runway into H2 2024, covering launch preparations if approved.
- FDA Priority Review for ADX-2191 (vitreoretinal lymphoma) with PDUFA June 21, 2023; no filing issues identified.
- FDA accepted NDA for reproxalap (dry eye disease) with PDUFA Nov 23, 2023; no advisory committee planned.
- Upcoming: Phase 3 INVIGORATE-2 allergic conjunctivitis, Phase 2 ADX-2191 RP, Phase 2 ADX-629 cough results expected H1 2023.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1341235/000115752323000419/0001157523-23-000419-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1341235/000115752323000419/a53358602.htm
  HTML page:      https://secwatch.observer/filing/0001157523-23-000419

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