FMP

FMP

Aldeyra Therapeutics Shares Lost 50% as TRANQUILITY Misses the Primary Endpoint of Ocular Redness

Aldeyra Therapeutics, Inc. (NASDAQ:ALDX) shares lost more than 50% following the company’s announcement, according to which its Ph.3 TRANQUILITY trial of reproxalap for Dry Eye Disease (DED) missed the primary endpoint of ocular redness, but did meet the secondary endpoint of Schirmer test.

Although disappointing and likely the result of disease variability, the company has another opportunity to meet a primary sign endpoint in the ongoing Ph.3 TRANQUILITY-2 trial that the analysts at Berenberg Bank believe should support its NDA filing expected in mid-2022. The company is increasing patient enrollment to include the primary endpoint of Schirmer test in addition to ocular redness.

The analysts have pushed out their expectations for the U.S. launch of reproxalap to 2023 from 2022, which resulted in lowering their price target on the company’s shares to $28 from $32.