Unicycive Resubmits OLC NDA With New Manufacturing Data; UNCY Falls 4.44%

Unicycive Therapeutics (UNCY) resubmitted its New Drug Application for oxylanthanum carbonate to the FDA on September 29, 2026, seeking approval of the oral phosphate binder for hyperphosphatemia in chronic kidney disease patients on dialysis. Shares fell 4.44% to $4.43. The resubmission includes Chemistry, Manufacturing and Controls data from a new third-party vendor, comprising 12 months of drug-product stability data and in vitro bridging data. The FDA inspected the facility in March 2024 and classified it as "No Action Indicated." The filing is supported by three clinical studies and is being pursued under the 505(b)(2) pathway. Unicycive said the June 2026 Complete Response Letter cited the same manufacturing deficiencies as the June 2025 CRL and raised no efficacy or safety concerns. The FDA is expected to decide on acceptance within 30 days. As of June 30, 2026, the company held $61.4 million in cash, funding operations into the second half of 2027.