09:17 AM EDT, 03/17/2026 (MT Newswires) -- Aldeyra Therapeutics ( ALDX ) shares were down more than 73% in recent Tuesday premarket activity after the biotechnology company said it has received a complete response letter from the US Food and Drug Administration for its reproxalap application for dry eye disease, citing insufficient evidence of effectiveness.

The drugmaker said the FDA cited inconsistent results across studies and said the overall data did not support the drug's intended effect, while identifying no safety or manufacturing issues.

The agency recommended further analysis of trial failures and identification of patient groups or conditions where the treatment may demonstrate benefit, Aldeyra said.

Aldeyra said the FDA did not request additional trials or new confirmatory data, and it does not currently plan to start new studies.

The company said it plans to seek a meeting with the FDA to determine a path forward for the application.

Aldeyra had $70 million in cash and investments as of Dec. 31, 2025, expected to fund operations through 2028, the company said.