By Colin Kellaher


Shares of Acer Therapeutics Inc. fell more than 10% and hit a new 52-week low on Tuesday after the pharmaceutical company said the U.S. Food and Drug Administration had rejected its application seeking approval of its lead drug candidate.

The Newton, Mass., company, which was seeking approval of ACER-001 for the treatment of patients with urea cycle disorders, said the agency turned away the application because it wasn't able to inspect a contract packaging manufacturer's facility.

Acer, which is developing ACER-001 in collaboration with Switzerland's Relief Therapeutics Holding SA, said the FDA didn't raise any approvability concerns related to the efficacy, safety or pharmacokinetics of ACER-001 and didn't request any additional clinical or pharmacokinetic studies.

Acer said it is working with the contract manufacturer and the FDA to address the agency's comments, and that it plans to resubmit the application in the third quarter. However, the company also warned that it couldn't give assurance that it would be able to meet the intended timeline, or that the FDA's inspection of the manufacturer's plant would be satisfactory.

Acer shares were recently changing hands at $1.52, down 13.6%, after hitting a 52-week low of $1.50 earlier in the session.


Write to Colin Kellaher at colin.kellaher@wsj.com


(END) Dow Jones Newswires

06-21-22 1145ET