FDA Raises Manufacturing Concerns, Delays Unicycive's Kidney Disease Drug Approval

The U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) on Monday for Unicycive Therapeutics, Inc.’s UNCY New Drug Application (NDA) for Oxylanthanum Carbonate (OLC) for hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis.

Hyperphosphatemia is a condition characterized by elevated phosphate levels in the blood, most commonly resulting from impaired kidney function, and can lead to complications like vascular calcification, organ damage, and increased mortality.

“We plan to immediately seek a Type A meeting with the Agency to gain alignment on the best strategy to ensure rapid resolution of the CRL,” said Shalabh Gupta, CEO of Unicycive. “With a second manufacturing, vendor identified that has produced OLC drug product, we remain optimistic about our ability to bring this promising new treatment option to patients with CKD on dialysis who are managing hyperphosphatemia, and we plan to provide an update as soon as we have additional clarity on next steps from the FDA.”

After submitting the NDA, and as a part of the application review and routine information requests, the FDA notified Unicycive that a third-party manufacturing vendor of its main contract development and manufacturing organization was cited for deficiencies following a cGMP inspection.

This citation is unrelated to OLC. Unicycive also notes that the Agency has not highlighted any other technical concerns related to the submitted CMC documentation or testing of OLC itself as part of the NDA review.

As part of its overall manufacturing strategy, the company had previously identified a backup third-party manufacturing vendor to build redundancy into its supply chain.

Unicycive currently has an unaudited cash balance of approximately $20.7 million, with a cash runway expected to last into the second half of 2026.

Earlier in June, following an inspection, the FDA identified deficiencies at a third-party subcontractor of Unicycive’s Contract Development and Manufacturing Organization. As a result, the FDA said any label discussions with the company are currently precluded.

Unicycive noted the issues do not involve its Drug Substance vendor and said it has responded to all FDA information requests.

In June, Unicycive Therapeutics implemented a 1-for-10 reverse split.

Price Action: UNCY stock was down 23.9% at $5.18 at the last check on Monday.

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