About Aldeyra Therapeutics, Inc. - Common Stock (ALDX)
Aldeyra Therapeutics is a biotechnology company focused on developing and commercializing innovative therapies to treat immune-mediated and metabolic diseases. The company is particularly known for its research in ocular disorders and rare diseases, utilizing its proprietary platform to create novel compounds that aim to modulate immune responses and address unmet medical needs. Aldeyra is committed to advancing its therapeutic pipeline through clinical trials, bringing potential new treatment options to patients facing debilitating health conditions. Read More
Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra), a biotechnology company devoted to discovering and developing innovative therapies designed to treat immune-mediated diseases, today announced receipt of a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) for the New Drug Application (NDA) of reproxalap, an investigational drug candidate, for the treatment of dry eye disease. The CRL stated that there is “a lack of substantial evidence consisting of adequate and well-controlled investigations … that the drug product will have the effect it purports or is represented to have under the conditions of use prescribed, recommended, or suggested in its proposed labeling” and that “the application has failed to demonstrate efficacy in adequate and well controlled studies in the treatment of signs and symptoms of dry eye disease.” The letter also stated that the “inconsistency of study results raises serious concerns about the reliability and meaningfulness of the positive findings” and that the “totality of evidence from the completed clinical trials does not support the effectiveness of the product.” Consistent with prior NDA reviews of reproxalap, no safety or manufacturing concerns were identified.
Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra), a biotechnology company devoted to discovering and developing innovative therapies designed to treat immune-mediated diseases, today announced that Todd C. Brady, M.D., Ph.D., President and Chief Executive Officer, will participate virtually in a fireside chat at the Oppenheimer 36th Annual Healthcare Life Sciences Conference.
Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra), a biotechnology company devoted to discovering and developing innovative therapies designed to treat immune-mediated diseases, today announced that the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) target action date for the reproxalap New Drug Application (NDA) for the treatment of dry eye disease. The extended PDUFA target action date is March 16, 2026.
Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra), a biotechnology company devoted to discovering and developing innovative therapies designed to treat immune-mediated diseases, today announced at a research and development webcast the expansion of the RASP platform to include programs in central nervous system diseases associated with inflammation, and provided updated manufacturing information on reproxalap.
Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra), a biotechnology company devoted to discovering and developing innovative therapies designed to treat immune-mediated diseases, today announced that Todd C. Brady, M.D., Ph.D., President and Chief Executive Officer, will participate in a fireside chat at the 2025 Jefferies Global Healthcare Conference in London, England.
Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra), a clinical-stage biotechnology company developing innovative therapies for the treatment of immune-mediated diseases, today announced that the company will host a Research & Development Update webcast on Thursday, November 13, 2025 at 8:00 a.m. ET.
Statistically significant improvement relative to baseline was observed in clinically relevant objective markers of hepatic function and inflammation in the study, the company said.
Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra), a biotechnology company devoted to discovering and developing innovative therapies designed to treat immune-mediated diseases, today announced achievement of statistically significant improvement in liver function in patients treated with ADX-629, an investigational new drug candidate, and focused the RASP modulator product candidate pipeline on next-generation molecules ADX-248 and ADX-246.
The SPDR S&P Biotech ETF (ARCA:XBI) is up more than 40% over the past six months and is on the verge of breaking out. Here's a look at several momentum standouts in the biotech space that appear to be rapidly gaining strength.
Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra), a biotechnology company devoted to discovering and developing innovative therapies designed to treat immune-mediated and metabolic diseases, today announced that Todd C. Brady, M.D., Ph.D., President and Chief Executive Officer, will participate in a fireside chat at the H.C. Wainwright 27th Annual Global Investment Conference on September 8, 2025.
Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra) today announced that the European Medicines Agency (EMA) has granted Orphan Designation for ADX-2191 (methotrexate intravitreal injection, USP) for the treatment of primary large B-Cell lymphomas of immune-privileged sites, including primary vitreoretinal lymphoma. There is currently no approved treatment for patients with primary vitreoretinal lymphoma, a rare, aggressive, high-grade cancer that affects approximately 100 to 200 people per year in the European Union.
Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra) today announced that the U.S. Food and Drug Administration (FDA) has granted fast track designation for ADX-2191 (methotrexate intravitreal injection, USP) for the treatment of retinitis pigmentosa. There is currently no approved treatment for patients with most forms of retinitis pigmentosa, a clinical group of rare genetic eye diseases characterized by retinal cell death and loss of vision. Retinitis pigmentosa affects more than one million people worldwide.
Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra), a biotechnology company devoted to discovering and developing innovative therapies designed to treat immune-mediated and metabolic diseases, today announced that Todd C. Brady, M.D., Ph.D., President and Chief Executive Officer, will participate in a fireside chat at the H.C. Wainwright 5th Annual Ophthalmology Virtual Conference on August 13, 2025.
