Aldeyra Therapeutics NASDAQ: ALDX Chief Executive Todd Brady said the company expects near-term feedback from the U.S. Food and Drug Administration on its dry eye disease candidate reproxalap, following a third complete response letter tied to efficacy questions.
Aldeyra Therapeutics stock plunges 71% after the FDA issues a third CRL for the resubmitted reproxalap NDA for the treatment of dry eye disease.
Here is how Aldeyra Therapeutics, Inc. (ALDX) and Iovance Biotherapeutics (IOVA) have performed compared to their sector so far this year.
| Biotechnology Industry | Healthcare Sector | Todd C. Brady CEO | XSTU Exchange | US01438T1060 ISIN |
| US Country | 9 Employees | - Last Dividend | - Last Split | - IPO Date |
Aldeyra Therapeutics, Inc. is a biotechnology enterprise focused on the invention and delivery of therapeutic solutions for immune-mediated diseases. Having begun its journey as Aldexa Therapeutics, Inc., the company underwent a rebranding in March 2014 to become Aldeyra Therapeutics, Inc. Since its establishment in 2004, and based out of Lexington, Massachusetts, it has dedicated itself to addressing the unmet needs of patients suffering from various immune-mediated conditions through the development and commercialization of novel medications.
As Aldeyra Therapeutics, Inc.'s flagship product candidate, reproxalap is a pioneering RASP (Reactive Aldehyde Species) modulator presently in Phase III clinical trials. It’s specifically aimed at treating dry eye diseases, showcasing the company's innovative approach to mitigating symptoms by targeting underlying inflammation.
This orally administered RASP modulator expands the company's portfolio into the treatment of COVID-19, atopic asthma, psoriasis, and alcohol intoxication. By regulating the body's immune response, ADX-629 represents a versatile approach with potential applications across a variety of immune-mediated diseases.
ADX-2191 is a dihydrofolate reductase inhibitor in development for the treatment of retinitis pigmentosa and other rare retinal diseases characterized by inflammation and vision loss. It emphasizes Aldeyra’s commitment to addressing rare diseases with significant unmet medical needs.
The company is also exploring the therapeutic potential of ADX-246 and ADX-248 in the realms of systemic immune-mediated disease and geographic atrophy, respectively. While specific details and trial phases are not disclosed, these products signify Aldeyra’s ongoing research and development efforts to broaden its impact on immune-mediated diseases.