Regulatory Setback For Applied Therapeutics' Lead Program, FDA Highlights Deficiencies In Clinical Application

1. FDA issued a Complete Response Letter for APLT's govorestat NDA. 2. Deficiencies in clinical application cited, delaying potential approval and launch. 3. William Blair downgraded success probability for galactosemia to 30%. 4. SORD program remains unaffected; potential revenue by late 2025 possible. 5. APLT stock dropped 67.2% following the FDA's decision.