BioCentury
ARTICLE | Regulation

Applied looks to next readout as FDA seeks more than biomarker data

Shares dip as long-planned galactosemia submission now on hold until clinical outcomes data clarify efficacy

January 5, 2022 12:13 AM UTC

The management team at Applied Therapeutics believed that years of discussions with FDA had set the company up for a pathway to accelerated approval of its galactosemia therapy, and is “surprised” that the agency wants to see clinical outcomes data for the product before considering its approval, Chairman, President and CEO Shoshana Shendelman told BioCentury.

Shares of Applied Therapeutics Inc. (NASDAQ:APLT) sank 31% on Monday, shaving more than $70 million from its market cap, after the company said an NDA submission for AT-007 to treat the rare disease will need to wait until the company has more data. Applied lost a further $0.40 to $5.82 on Tuesday...

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