Applied Therapeutics granted pre-NDA meeting by FDA for govorestat

Applied Therapeutics provided a regulatory update on the Galactosemia program, including updates on the regulatory paths for govorestat in both the U.S. and Europe. The United States Food and Drug Administration has granted a Pre-New Drug Application meeting to be held this summer to discuss a potential NDA submission for govorestat for the treatment of Galactosemia. The Company believes that the clinical efficacy demonstrated to date, combined with galactitol biomarker data and a favorable safety profile, may support an NDA submission, and is seeking feedback from the FDA and alignment on the details of the submission. If the FDA is in agreement on the potential path forward to approval, the Company will plan to submit an NDA in the fall. The Company expects to provide a further update following the meeting. Regarding regulatory submission plans in Europe, Applied Therapeutics and its European commercial partner, Advanz Pharma, met with the European Medicines Agency rapporteurs earlier this summer, and plan to proceed with an EMA Marketing Authorization Application submission as expeditiously as possible. The EMA submission is anticipated in the fall in order to provide sufficient time for approval of the Pediatric Investigational Plan, as well as incorporation of rapporteur comments and suggestions from the meeting.