Aldeyra Therapeutics (NASDAQ:ALDX) lost ~74% in the premarket on Thursday after the company said that the U.S. Food and Drug Administration (FDA) for the second time declined to approve its lead asset, reproxalap, targeted at the ophthalmic disorder dry eye disease.

Issuing a complete response letter regarding ALDX’s new drug application resubmitted in 2024, the regulator has required the company to conduct an additional clinical trial to show the clinical efficacy of reproxalap in addressing the ocular symptoms of DED.

Lexington, Massachusetts-based Aldeyra (NASDAQ:ALDX) was forced to seek the FDA nod for reproxalap in DED for the second time after the agency refused to approve its initial NDA in 2023, citing a need for at least one additional symptom trial.

Despite the latest setback, the company said it would resubmit the NDA in mid-2025 following a Type A meeting scheduled to take place about 30 days from the issuance of the CRL.

“Pending positive results from the ongoing clinical trials and discussions with the FDA, we look forward to a potential NDA resubmission mid-year 2025,” CEO Todd Brady added.