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Investing.com -- Shares of Aldeyra Therapeutics, Inc. (NASDAQ:ALDX) plunged 75% following the receipt of a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for reproxalap, intended to treat signs and symptoms of dry eye disease. The FDA’s letter highlighted the NDA’s failure to demonstrate efficacy in adequate and well-controlled studies for treating ocular symptoms associated with dry eyes.
The FDA’s concerns were based on potential methodological issues in the trial data, including a disparity in baseline scores across treatment arms, which could have affected the results. The regulatory body has requested at least one additional adequate and well-controlled study to establish a positive effect on ocular symptoms treatment for dry eye disease. This setback comes despite the company previously conducting multiple clinical trials and submitting data as part of an initial NDA in November 2022, followed by a resubmission in October 2024 after achieving the primary endpoint in a dry eye chamber clinical trial.
Aldeyra Therapeutics has planned to announce top-line results from ongoing field and chamber clinical trials in the second quarter of 2025. Subject to positive outcomes and further discussions with the FDA, the company aims to resubmit the NDA by mid-year 2025. The review period for the potential NDA resubmission is anticipated to be six months.
Despite the current hurdle, Aldeyra reported a solid financial standing with $101 million in cash, cash equivalents, and marketable securities as of December 31, 2024. The company also noted that a majority of the costs for the ongoing clinical trials were incurred in 2024, with an estimated $6 million expected for the full-year 2025.
Aldeyra’s CEO, Todd C. Brady, M.D., Ph.D., expressed optimism about the future, stating, “Pending positive results from the ongoing clinical trials and discussions with the FDA, we look forward to a potential NDA resubmission mid-year 2025.” He emphasized reproxalap’s unique position as the only late-stage topical ocular therapy suitable for chronic administration that has potentially demonstrated both acute reduction in ocular redness and discomfort, addressing the signs and symptoms of dry eye disease. However, this recent communication from the FDA has clearly impacted investor confidence, reflected in the significant drop in the company’s stock price.
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