ACER - Acer/Relief urea cycle disorder therapy still under FDA review surpassing target date

Acer Therapeutics (NASDAQ:ACER) said the U.S. Food and Drug Administration (FDA) has not yet made a decision on its application for ACER-001 seeking approval of the drug for urea cycle disorders (UCDs). The FDA had accepted the company's new drug application (NDA) for review on Oct. 5, and was expected to make a decision by June 5. Acer said that the FDA informed the company that the review for ACER-001 (sodium phenylbutyrate) is ongoing and the agency currently does not have a set target date. The company said it will issue a press release once FDA provides a written decision to it. Relief Therapeutics (OTCQB:RLFTF) and Acer (ACER) have a development and commercialization agreement for ACER-001.

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Acer/Relief urea cycle disorder therapy still under FDA review, surpassing target date