earnings
confidence high
sentiment positive
materiality 0.70
Applied Therapeutics Q1 net loss $83.9M; govorestat NDA PDUFA Nov 28, 2024
Applied Therapeutics, Inc.
2024-Q1 EPS reported
-$0.67
revenue$190,000
- Net loss $83.9M ($0.67/share) vs $10.1M ($0.18/share) Q1 2023; cash $146.5M up from $49.9M.
- Govorestat NDA for Classic Galactosemia under priority review; PDUFA date Nov 28, 2024.
- MAA under EMA review; decision expected early Q1 2025 after Day 120 clock-stop extension.
- Discussing potential NDA submission for SORD Deficiency under Accelerated Approval with FDA.
- Appointed Dale Hooks as Chief Commercial Officer; presented Phase 3 ARISE-HF data at ACC.