#FDA #Pomerantz #Aldeyra

Pomerantz Law Firm Investigates Aldeyra Therapeutics

Pomerantz LLP, a distinguished law firm with a strong reputation in securities and antitrust class litigation, has recently embarked on an investigation aimed at uncovering potential securities fraud claims on behalf of investors associated with Aldeyra Therapeutics, Inc. (NASDAQ: ALDX). The firm is extending an invitation to affected investors to come forward and seek assistance in this matter.

The investigation was prompted by alarming news emanating from Aldeyra, which publicly revealed that it had received a Complete Response Letter from the U.S. Food and Drug Administration (FDA) regarding the resubmission of its New Drug Application (NDA) for reproxalap, a product intended for treating dry eye disease. On April 3, 2025, this press release from Aldeyra notably indicated that while there were no manufacturing or safety issues with reproxalap, the FDA concluded that the NDA "failed to demonstrate efficacy in adequate and well-controlled studies in treating ocular symptoms associated with dry eyes."

Furthermore, the FDA highlighted that the company must conduct at least one more adequate and controlled study to verify the drug’s positive impact on treating the ocular symptoms in patients suffering from dry eye condition. This revelation raised serious concerns about the integrity of the trial data submitted for review, as noted by potential methodological issues, particularly the differing baseline scores across the various treatment arms involved in the trial.

In light of this news, Aldeyra's stock experienced a drastic plummet, losing $3.90 per share, which translates to a staggering 73.31% drop, closing at a mere $1.42 per share on the same day. This decline has undoubtedly led to significant distress among investors, hence the initiation of investigations by Pomerantz.

Founded by the late Abraham L. Pomerantz, a prominent figure in the legal field often regarded as the