By Dhirendra Tripathi

Investing.com – Applied Therapeutics stock (NASDAQ:) sank 25% in Monday’s pre-market trading after receiving bad news from the FDA for the company’s lead drug candidate.

An earlier expectation was that AT-007 would be approved by the Food and Drug Administration. But, the regulator now states that the FDA will require data from clinical outcomes to approve it. In the meantime, the FDA is continuing discussions and the company decided not to submit a second drug application for AT007.

Release stated that the initial clinical assessment will be done in the first quarter, then each 6 months until the study attains statistical significance.

AT-007 is being developed by the company to treat galactosemia. This rare metabolic disorder results in inability of galactose simple sugars to be metabolized. Galactose becomes toxic when it isn’t metabolized correctly, causing neurological problems such as impaired speech, cognition, and behavioral skills.

AT-007, a Phase 3 clinical outcomes trial for galactosemia Kids in 2-17 year-olds is currently under investigation. Galactosemia is a common condition in America, with approximately 3,000 cases and about 80 births each year.