Shares of Applied Therapeutics, Inc. (NASDAQ: APLT) are experiencing notable gains during the pre-market session today. As of the latest check, APLT stock was trading at $6.61 on the US stock charts, about 42% higher from the previous close.
Regulatory Progress for Govorestat
A significant update on the New Drug Application (NDA) for govorestat, a medication intended to treat Classic Galactosemia, has been released by Applied Therapeutics. The US Food and Drug Administration and the firm wrapped up a late-cycle review meeting recently (FDA). The FDA said during this meeting that it would not be necessary to have the tentatively scheduled October 9, 2024, Advisory Committee meeting.
The FDA attested that the NDA’s Priority Review is moving along according to schedule, with post-marketing requirements expected to be finalized by October 2024. November 28, 2024, is still the anticipated action date for the Prescription Drug User Fee Act (PDUFA).
Continued Cooperation and Prospects
Applied Therapeutics has engaged in continuous dialogue with the FDA throughout the NDA review process and remains committed to collaborating with the agency to potentially provide the first treatment for Classic Galactosemia patients. This progressive disease urgently requires new therapeutic options, and the potential approval of govorestat represents a transformative development for affected patients and their families.
Applied Therapeutics’ dedication to the Classic Galactosemia community is evident through strategic commercial preparations, which include developing a robust patient access program, enhancing physician awareness, and fostering strong payor engagement.
European Market Considerations
Applied Therapeutics has submitted a Marketing Authorization Application (MAA) for govorestat to the European Medicines Agency (EMA) in addition to the FDA evaluation. The EMA’s Committee for Medicinal Products for Human Use is presently reviewing this application, which was validated in December 2023 (CHMP).
Applied Therapeutics (APLT) expects an early 2025 judgment from the EMA, following a three-month extension granted in April 2024. The NDA and MAA submissions are underpinned by evidence of a significant reduction in galactitol levels, which correlates with improved clinical outcomes in pediatric patients and a favorable safety profile.
