Aldeyra (ALDX) 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. Based on new preclinical results in models of Parkinson’s disease and amyotrophic lateral sclerosis, which included improved grip strength, balance, and biomarkers of central nervous system function, potential clinical indications for the orally administered, next-generation RASP modulator ADX-248 were expanded to include neuroinflammatory diseases that affect the central nervous system. The FDA completed routine site inspections of reproxalap drug substance and drug product manufacturing facilities in 2025. The inspections resulted in Voluntary Action Indicated designations, and the FDA has notified the manufacturers that the inspections are closed, and that no further action was necessary.
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