Aldeyra Therapeutics, Inc. (ALDX) Faces Scrutiny After Stock Drops 70% On FDA's Reproxalap Complete Response Letter – Hagens Berman

Core Viewpoint - Aldeyra Therapeutics, Inc. experienced a significant decline in share price, dropping over 70% after receiving a Complete Response Letter from the FDA regarding its New Drug Application for reproxalap, a treatment for dry eye disease, leading to a loss of over $200 million in market capitalization [1][2][4]. Company Overview - Aldeyra Therapeutics, Inc. is focused on developing reproxalap for the treatment of dry eye disease, previously claiming successful Phase 3 trial results and assuring investors of imminent FDA approval [4][6]. - The FDA's Complete Response Letter indicated that the NDA did not demonstrate adequate efficacy and required at least one additional controlled study to validate the treatment's effectiveness [6]. Market Reaction - Following the announcement of the FDA's CRL, Aldeyra's share price plummeted, resulting in a substantial loss of shareholder value [2][4]. - The market's swift reaction reflects investor sentiment and confidence in the company's previous assurances regarding FDA approval [1][4]. Legal Investigation - Hagens Berman, a law firm, has initiated an investigation into potential securities law violations by Aldeyra, focusing on whether the company misrepresented the prospects of FDA approval [2][5]. - The firm is encouraging investors who suffered losses to come forward and assist in the investigation [3][5].