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Acer Therapeutics Resubmits FDA Application for ACER-001

By Colin Kellaher

 

Acer Therapeutics Inc. on Monday said it has once again filed for U.S. Food and Drug Administration approval of ACER-001 for the treatment of patients with urea cycle disorders.

The FDA in June rejected Acer's application for its lead drug candidate after the agency couldn't complete an inspection of a third-party contract packaging manufacturer because its plant wasn't ready for inspection.

Acer, a Newton, Mass., pharmaceutical company that is developing ACER-001 in collaboration with Switzerland's Relief Therapeutics Holding SA, said it believes the resubmission addresses the FDA's concerns in full, adding that the contract manufacturer is now ready for inspection by the agency.

Acer said it expects notification of the FDA's decision to accept or reject the resubmission for review within 14 days of the agency's receipt.

 

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

 

(END) Dow Jones Newswires

July 18, 2022 09:00 ET (13:00 GMT)

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