Applied Therapeutics raises $100M; FDA accepts govorestat NDA with Priority Review, PDUFA Aug 28

Applied Therapeutics, Inc.

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.

Key facts

Extracted from this filing and checked against the source text.

Material Agreements SEC 8-K Item 1.01/1.02 confidence 0.9

Applied Therapeutics, Inc. entered into Securities Purchase Agreement with a select group of accredited investors valued at approximately $100 million (effective 2024-02-27).

Action: entry
Agreement: equity purchase
Counterparty: a select group of accredited investors
Value: approximately $100 million
Effective: 2024-02-27

Exact text from the filing

On February 27, 2024, Applied Therapeutics, Inc. (the “Company”) entered into a Securities Purchase Agreement (the “Securities Purchase Agreement”) for a private placement (the “Private Placement”) with a select group of accredited investors (collectively, the “Purchasers”).

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Source: SEC EDGAR

accession 0001104659-24-029384

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