Acer Says FDA Accepts NDA for ACER-001 in Urea-Cycle Disorders; Shares Up

By Michael Dabaie

Acer Therapeutics Inc. and collaboration partner Relief Therapeutics Holding SA said the U.S. Food and Drug Administration accepted for filing the new drug application for ACER-001 in urea-cycle disorders.

The FDA assigned a Prescription Drug User Fee Act target action date of June 5, 2022.

UCDs are a group of disorders caused by genetic mutations that result in a deficiency in one of the six enzymes that catalyze the urea cycle. That can lead to an excess accumulation of ammonia in the bloodstream, or hyperammonemia. Acute hyperammonemia can cause lethargy, somnolence, coma, and multi-organ failure, while chronic hyperammonemia can lead to headaches, confusion, lethargy, failure to thrive, behavioral changes, and learning and cognitive deficits.

Acer shares rose 18%, to $2.93, in pre-market trading.

Write to Michael Dabaie at [e-mail]

(END) Dow Jones Newswires

10-06-21 0901ET