Update: Applied Therapeutics' Shares Fall After FDA Rejects NDA for Govorestat in Classic Galactosemia

MT Newswires Live

2024/11/29

(Updates with share price movement in the headline and first paragraph.)

Applied Therapeutics (APLT) shares fell over 75% premarket Friday after the company disclosed late Wednesday that the US Food and Drug Administration issued a complete response letter indicating its decision not to approve a new drug application for govorestat to treat classic galactosemia due to "deficiencies in the clinical application."

The drugmaker said it is reviewing the regulator's feedback and plans to request a meeting to discuss requirements for a potential NDA resubmission or appeal.

Govorestat is also being developed to treat sorbitol dehydrogenase deficiency, the company said, adding it plans to file an NDA for that indication in Q1 2025.

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