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UNCY. disaster du jour ( or a buying op ? More experienced biotech investors here , please opine )
GlobeNewswire
Unicycive Provides Update on New Drug Application for Oxylanthanum Carbonate to Treat Hyperphosphatemia in Patients with Chronic Kidney Disease on Dialysis
Unicycive Therapeutics, Inc.
Tue, June 10, 2025 at 3:00 AM PDT 5 min read


In This Article:
UNCY
-24.21%

Unicycive Therapeutics, Inc.
Unicycive Therapeutics, Inc.
- The U.S. Food and Drug Administration (FDA) identified deficiencies at a third-party manufacturing vendor

- FDA to provide final decision by PDUFA action date of June 28, 2025

LOS ALTOS, Calif., June 10, 2025 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY or the “Company”), a clinical-stage biotechnology company developing therapies for patients with kidney disease, today announced an update on its New Drug Application (NDA) for oxylanthanum carbonate (OLC) to treat hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis.


The FDA communicated to the Company that it had identified deficiencies in cGMP compliance at a third-party manufacturing vendor (one of its CDMO's third-party subcontractors and not its Drug Substance vendor) following an FDA inspection.

The FDA indicated that, given the identified deficiencies, any label discussions between the FDA and the Company are precluded. The Company has responded to all FDA information requests and expects a final decision from the FDA by the PDUFA action date of June 28, 2025.

Kiwi