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The FDA Issues Complete Response Letter For Unicycive Therapeutics' New Drug Application For Oxylanthanum Carbonate To Treat Hyperphosphatemia In Patients With Chronic Kidney Disease On Dialysis

Author: Benzinga Newsdesk | June 30, 2025 06:09am

Complete Response Letter (CRL) cited deficiencies previously identified at a third-party manufacturing vendor unrelated to Oxylanthanum Carbonate (OLC).
No other concerns stated, including pre-clinical, clinical, or safety data.
The Company identified a second manufacturing vendor that has already produced OLC drug product, which could also be used to support the resolution of the Clinical Manufacturing and Controls (CMC) issues identified in the CRL.
The Company plans to immediately request a Type A meeting with the FDA to align on next steps.
Unicycive currently has an unaudited cash balance of approximately $20.7 million, with cash runway currently expected into the second half of 2026

Posted In: UNCY