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ALDX FDA decision: Mar 17, 2026

Page updated ·next FDA decision on the calendar ·Data as of Oct 11, 2026 9:31 PM ET
The FDA's own letter · Complete Response Letter, NDA 216442 (PDF), dated March 16, 2026, released under FDA's CRL transparency program. The company announced the decision on March 17, 2026; the FDA acted on March 16, 2026.
✕ COMPLETE RESPONSE LETTER

Aldeyra Therapeutics Inc., Reproxalap (ADX-102) · Dry Eye Disease.

Run-up into the decision (T-120 → T+5)

PDUFA 3/17/26$5.74$3.999/30/25
Daily close, T-120 (9/30/25) through T+5. Run-up high $5.74 on 10/10/25, low $3.99 on 12/19/25 (T-120 to T-1). FDA decision 3/17/26. Historical price action, not a forecast.

Key facts

FDA decision date2026-03-17
OutcomeCRL
Drug / candidateReproxalap (ADX-102) - (CHAMBER)
CompanyAldeyra Therapeutics Inc.
120-day run-up (T-120→T-1)-17.2%

Every FDA approval letter and released Complete Response Letter we hold, by FDA action date: FDA approval letters.

Questions

Was Reproxalap (ADX-102) approved by the FDA?

Not in this review cycle. A Complete Response Letter, declining to approve the application for Reproxalap (ADX-102) in its current form, was announced on March 17, 2026. A CRL is not final; the primary source is linked on this page.

Which company is behind Reproxalap (ADX-102)?

Reproxalap (ADX-102) is an Aldeyra Therapeutics Inc. (ALDX) program. The company announced the FDA decision on March 17, 2026; the FDA's own record of the decision is linked on this page.

How did ALDX stock trade into the FDA decision?

Measured over the 120 trading days before the decision (T-120 to T-1), ALDX moved -17.2%. That is the recorded price path into this specific event. Historical measurement, not a prediction, and not investment advice.