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Applied Therapeutics Gets Fast Track Designation from FDA

Applied Therapeutics says drug candidate to treat rare disorder affecting sugar processing gets fast track designation from the FDA.

Applied Therapeutics  (APLT) - Get Applied Therapeutics, Inc. Report said Thursday that the U.S. Food and Drug Administration granted the biopharma fast track designation to its drug candidate for the treatment of a rare disorder that inhibits the body’s ability to process a simple sugar.

Shares of the New York company were up 1.50% to $23.29 at last check.

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Applied Therapeutics said its candidate, AT-007, is intended for the treatment of galactosemia. 

AT-007 is the company’s central nervous system-penetrant Aldose Reductase inhibitor in development for multiple rare metabolic disorders.

The company said AT-007 significantly reduced plasma galactitol levels compared with a placebo in adults with Galactosemia in a Phase 2 registrational trial. The long-term extension in adults remains ongoing.

AT-007 is currently being studied in a registrational trial in children ages 2-17 with galactosemia.

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Applied Therapeutics said it plans to submit a new drug application for accelerated approval of AT-007 for the treatment of galactosemia in the third quarter.

The FDA has previously granted orphan drug designation and pediatric rare disease status to AT-007 for galactosemia. 

The Orphan Drug Designation Program provides orphan status to drugs and biologics that are intended for the treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people.

The fast track designation is granted to drugs being developed for the treatment of serious or life-threatening diseases or conditions where there is an unmet medical need.

"There are currently no drugs approved for galactosemia, and we believe AT-007 has the potential to be the first drug approved for patients urgently in need of treatment," Shoshana Shendelman, founder and CEO, said in a statement. 

Separately, Nanox Imaging  (NNOX) - Get Nano X Imaging LTD Report shares on Thursday jumped after the medical imaging technology company said it applied to the FDA for clearance of a system that produces scans of human body parts.

Earlier this month, Constellation Pharmaceuticals  (CNST) - Get Constellation Pharmaceuticals, Inc. Report after it agreed to be acquired by the Munich biopharma MorphoSys  (MOR) - Get MorphoSys AG Sponsored ADR Report for $34 a share, or $1.7 billion, cash.

Last month, Syros Pharmaceuticals  (SYRG) jumped after an Oppenheimer analyst assigned a buy rating to the biopharma.