secwatch.observer — SEC 8-K summary
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Issuer:     Applied Therapeutics, Inc. (—)
CIK:        0001697532
Form:       8-K
Filed at:   2024-02-29T23:59:59+00:00
Accession:  0001104659-24-029384
Event type: other_material
Sentiment:  positive
Materiality: 0.85
Item codes: 1.01, 3.02, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Applied Therapeutics raises $100M; FDA accepts govorestat NDA with Priority Review, PDUFA Aug 28
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- Private placement of 12,285,714 shares at $7.00/share and 2M pre-funded warrants at $6.999 for gross proceeds of ~$100M.
- FDA accepted NDA for govorestat (AT-007) for Classic Galactosemia with Priority Review; PDUFA target date Aug 28, 2024.
- Cash balance $43.6M as of Feb 23, 2024; combined with private placement proceeds and milestones expected to extend runway into 2026.
- Investors include Perceptive Advisors, Janus Henderson, Venrock, Adage Capital, Frazier Life Sciences, Logos Capital, others.
- Govorestat previously received Orphan Drug, Pediatric Rare Disease, and Fast Track designations; MAA under EMA review, decision expected Q4 2024.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1697532/000110465924029384/0001104659-24-029384-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1697532/000110465924029384/tm247481d1_8k.htm
  HTML page:      https://secwatch.observer/filing/0001104659-24-029384

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