secwatch.observer — SEC 8-K summary
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Issuer:     Applied Therapeutics, Inc. (—)
CIK:        0001697532
Form:       8-K
Filed at:   2024-05-09T23:59:59+00:00
Accession:  0001104659-24-059107
Event type: earnings
Sentiment:  positive
Materiality: 0.70
Item codes: 2.02, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Applied Therapeutics Q1 net loss $83.9M; govorestat NDA PDUFA Nov 28, 2024
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- 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.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1697532/000110465924059107/0001104659-24-059107-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1697532/000110465924059107/tm2413888d2_8k.htm
  HTML page:      https://secwatch.observer/filing/0001104659-24-059107

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer