By Michael Dabaie

Acer Therapeutics Inc. shares were up 15% to $2.87 after the U.S. Food and Drug Administration accepted a new drug application.

Acer and collaboration partner Relief Therapeutics Holding SA said before the market open that the Food and Drug Administration accepted for filing the new drug application for ACER-001 in urea-cycle disorders, with a target action date of June 5, 2022.

UCDs 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.

The company said it continues to work with partners to ensure it is well positioned to support a commercial launch of ACER-001.

"With FDA commencing a substantive review of our NDA, ACER-001 is one step closer to potentially providing an alternative treatment option for patients with UCDs," said Acer Chief Executive Chris Schelling.

Write to Michael Dabaie at michael.dabaie@wsj.com

(END) Dow Jones Newswires

10-06-21 1509ET