In a recent development, the U.S. Food and Drug Administration (FDA) has announced an extension of the review period for Applied Therapeutics Inc.'s drug govorestat, a treatment for Classic Galactosemia. The new Prescription Drug User Fee Act (PDUFA) target action date has been set for November 28, 2024, extending the review period by three months. Govorestat (AT-007) is an investigational Aldose Reductase Inhibitor (ARI) that has shown promising results in reducing galactitol, a toxic metabolite associated with Galactosemia. Applied Therapeutics remains confident in the potential approval of govorestat and continues to provide the drug to patients through an expanded access program. The CEO of Applied Therapeutics, Shoshana Shendelman, PhD, has expressed the company's commitment to working closely with the FDA throughout the review process. Additionally, govorestat has also been submitted for review to the European Medicines Agency (EMA), with a decision expected in Q4 2024 [ffd065a6].