Shares of biotech firm Aldeyra Therapeutics ALDX.O slump 74% to an all-time low of $1.07
FDA declines to approve its application for experimental dry eye drug, reproxalap, citing lack of reliable evidence it works
Health regulator, in its so-called complete response letter, flags inconsistent results across trials and says studies did not clearly show benefit on signs and symptoms
Agency finds no safety or manufacturing issues, but advises ALDX to analyze failed trials and patient subgroups
ALDX says it will not run new trials and plans to seek a meeting with the FDA to discuss next steps
Shares up ~4% in 2025