ALDX

Relative to Baseline, Signal-Finding Molecule ADX‑629 Demonstrated Statistically Significant Improvement in Liver Function in Patients with Alcohol-Associated Hepatitis RASP Modulator Product Candidate Pipeline Focused on ADX‑248 and ADX‑246 for Dermatologic, Metabolic, and Retinal Immune-Mediated Diseases Cash Runway Extended into the Second Half of 2027 LEXINGTON, Mass., October 28, 2025--(BUSINESS WIRE)--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. ADX-629, a signal-finding RASP modulator for proof-of-concept clinical testing, was administered orally for one month in a single-arm, multicenter Phase 2 clinical trial in four patients with mild to moderate alcohol-associated hepatitis. Relative to baseline, statistically significant improvement was observed in clinically relevant objective markers of hepatic function and inflammation, including the Model for End-Stage Liver Disease (MELD) score (P=0.001), triglyceride levels (P<0.0001), and levels of C-Reactive Protein (P<0.0001). No serious adverse events were reported, and no adverse events were deemed related to ADX-629. "Consistent with clinical trials in patients with atopic dermatitis, psoriasis, chronic cough, and asthma, the orally administered RASP modulator ADX-629, relative to baseline, demonstrated activity in improving liver function and reducing inflammation in patients with mild to moderate alcohol-associated hepatitis, a chronic and challenging disease that proves difficult to manage in many cases," stated Todd C. Brady, M.D., Ph.D., President and Chief Executive Officer of Aldeyra. "The positive results announced today, which we look forward to sharing in more detail in the future, mark the culmination of our clinical proof of concept with ADX-629, as we focus our pipeline on next-generation RASP modulators ADX-248 and ADX-246 for the treatment of immune-mediated diseases." The RASP modulator product candidate pipeline was updated: Based on Phase 1 clinical trial results generated to date in heal...

LEXINGTON, Mass., May 05, 2025--(BUSINESS WIRE)--Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra) today announced it will host a webcast and conference call on Tuesday, May 6, 2025, at 8:00 a.m. ET to announce topline results from Phase 3 dry eye disease clinical trials of reproxalap. The dial-in numbers are (833) 470-1428 for domestic callers and (404) 975-4839 for international callers. The access code is 127477. A live audio webcast of the conference call will also be accessible from the "Investors & Media" section of Aldeyra's website at ir.aldeyra.com. After the live webcast, the event will remain archived on Aldeyra’s website for 90 days. About ReproxalapReproxalap is an investigational new drug candidate in development for the treatment of dry eye disease and allergic conjunctivitis, two of the largest markets in ophthalmology. Reproxalap is a first-in-class small-molecule modulator of RASP, which are elevated in ocular and systemic inflammatory diseases. The mechanism of action of reproxalap has been supported by the demonstration of statistically significant and clinically relevant activity in multiple physiologically distinct late-phase clinical indications. Reproxalap has been studied in more than 2,900 patients with no observed safety concerns; mild and transient instillation site irritation is the most commonly reported adverse event in clinical trials. About AldeyraAldeyra Therapeutics is a biotechnology company devoted to discovering innovative therapies designed to treat immune-mediated and metabolic diseases. Our approach is to develop pharmaceuticals that modulate protein systems, instead of directly inhibiting or activating single protein targets, with the goal of optimizing multiple pathways at once while minimizing toxicity. Our product candidates include RASP (reactive aldehyde species) modulators ADX-629, ADX‑248, ADX-743, ADX-631, ADX-246, and chemically related molecules for the potential treatment of systemic and retinal immune-mediated and metabolic diseases. Our late-stage product candidates are reproxalap, a RASP modulator for the potential treatment of dry eye disease and allergic conjunctivitis, and ADX-2191, a novel formulation of intravitreal methotrexate for the potential treatment of retinitis pigmentosa. View source version on businesswire.com: https://www.businesswire.com/news/home/20250505228210/en/ Contacts Investor...