The stock of Applied Therapeutics has plummeted after the FDA rejected its Metabolic Disease drug

The Key Takeaways

• Applied Therapeutics' application for a treatment of a rare metabolic disease was rejected by the Food and Drug Administration.
• The FDA said the drug, govorestat for galactosemia, had "deficiencies in the clinical application."
• Shares in Applied Therapeutics fell 75% after Friday’s news.

Applied Therapeutics shares plummeted Friday after the biopharmaceutical giant reported that FDA rejected their application for an experimental treatment of a rare disease called Galactosemia.

The company said it had received a Complete Response Letter (CRL) from the FDA that explained that after it completed a review of the drug, govorestat, it was unable to approve Applied Therapeutics' New Drug Application (NDA) in its current form. The FDA pointed to "deficiencies in the clinical application."

Galactosemia patients cannot digest the sugar galactose. About 3,300 Americans and 4,400 European Union citizens suffer from Galactosemia, according to the firm. “Newborn screening for Galactosemia is mandatory in the U.S. and most E.U. countries,” “The company” said.

Shoshana Shndelman, the CEO and founder of Shoshana Group (founded in 1998) expressed her disappointment at this decision. She argued that it was a govorestat “has the potential to change the lives of patients with Galactosemia, which we believe is evidenced by the breadth of efficacy and safety data demonstrating its ability to stop the decline on progressive clinical outcomes, including cognition and behavior.”

Applied Therapeutics Plans Request Meeting with FDA or Appeal FDA’s Decision

Applied Therapeutics added that it is "reviewing the feedback from the FDA and plans to immediately request a meeting to discuss requirements for a potential resubmission of the NDA or appeal of the decision along with appropriate next steps."

Applied Therapeutics shares lost around three quarters of their worth at the beginning of morning trading. 

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