secwatch.observer — SEC 8-K summary
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Issuer:     Aldeyra Therapeutics, Inc. (ALDX)
CIK:        0001341235
Form:       8-K
Filed at:   2026-09-29T11:01:15+00:00
Accession:  0001193125-26-405954
Event type: regulatory
Sentiment:  neutral
Materiality: 0.60
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4.1-flash:cloud@v2

Aldeyra to appeal FDA's March 16 CRL for reproxalap dry eye; cash runway extended to 2029
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- Plans Formal Dispute Resolution Request to FDA's Office of New Drugs appealing the March 16, 2026 Complete Response Letter denying approval of reproxalap for dry eye disease.
- FDRR submission and OND meeting expected in Q4 2026; FDA has issued three CRLs for reproxalap after the original NDA and two resubmissions.
- Most recent CRL did not request further trials but said totality of evidence from completed trials does not support effectiveness; prior two CRLs recommended an additional clinical trial.
- Aldeyra cites data from nine adequate and well-controlled clinical trials, five of which achieved all multiplicity-controlled primary endpoints.
- Reported $45.1M cash and equivalents as of June 30, 2026; projected operational cash runway extended into 2029.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1341235/000119312526405954/0001193125-26-405954-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1341235/000119312526405954/aldx-20260929.htm
  HTML page:      https://secwatch.observer/filing/0001193125-26-405954

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