Unicycive resubmits FDA application for phosphate treatment drug

• Unicycive Therapeutics resubmitted its FDA New Drug Application for oxylanthanum carbonate, a treatment for high phosphate levels in dialysis patients.
• The resubmission includes updated manufacturing information, 12 months of stability data, and comparisons between manufacturing vendors.
• The company expects FDA acceptance within 30 days and a potential review deadline six months after resubmission.

Unicycive Therapeutics (NASDAQ:UNCY) resubmitted its New Drug Application (NDA) to the U.S. Food and Drug Administration for oxylanthanum carbonate, an investigational treatment for hyperphosphatemia in patients receiving dialysis.

The resubmitted application includes manufacturing data from a new drug-product vendor, 12 months of product stability data, and laboratory comparisons between products manufactured by the previous and new vendors.

Unicycive said the new vendor’s manufacturing facility received a “No Action Indicated” classification following an FDA inspection in March 2024.

The company expects the FDA to accept the resubmitted application within 30 days and assign a review deadline approximately six months after resubmission.

The FDA’s June 2026 complete response letter identified previously reported manufacturing deficiencies at the original vendor.

The agency did not raise concerns regarding clinical efficacy or safety data and did not request additional clinical information from Unicycive.

The company said the original vendor’s reinspection had not taken place as of September 29, 2026.

As of June 30, 2026, Unicycive reported unaudited cash, cash equivalents, and marketable securities of $61.4 million, supporting an expected cash runway into the second half of 2027.