Unicycive FDA update: cGMP deficiencies at OLC manufacturing subcontractor; PDUFA June 28

Unicycive Therapeutics, Inc.

FDA identified cGMP deficiencies at a third-party manufacturing subcontractor (not drug substance vendor) for oxylanthanum carbonate.
Label discussions precluded due to deficiencies; company has responded to all FDA information requests.
Final FDA decision expected by PDUFA action date of June 28, 2025.
Company is working with partners to resolve FDA concerns.
CEO expresses confidence in OLC based on clinical and preclinical data.

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