Unicycive Therapeutics' Oxylanthanum Carbonate NDA Resubmission Gets FDA Acceptance, Stock Up

Unicycive Therapeutics (UNCY) announced the FDA accepted its resubmission for oxylanthanum carbonate, a drug for chronic kidney disease. The FDA set a target action date of March 25, 2027, and the resubmission includes data from a new manufacturing vendor. The company received a Complete Response Letter in June 2026 due to issues with the original manufacturer. Unicycive seeks approval via the 505(b)(2) pathway.

Unicycive Therapeutics (UNCY) announced the FDA accepted its resubmitted NDA for oxylanthanum carbonate, setting a PDUFA action date of March 25, 2027. The resubmission includes CMC data from a new manufacturer, addressing prior CRLs related to manufacturing issues.

Unicycive Therapeutics (Nasdaq: UNCY) announced the FDA accepted its resubmitted NDA for oxylanthanum carbonate, a kidney-disease drug, with a PDUFA target action date of March 25, 2027. The resubmission includes new manufacturing data. The FDA did not raise concerns about the drug's clinical or safety data.

Unicycive Therapeutics (Nasdaq: UNCY) resubmitted its NDA for oxylanthanum carbonate, an oral phosphate binder for CKD patients on dialysis. The resubmission includes new CMC data from a different vendor. The company expects FDA acceptance within 30 days and a PDUFA date 6 months from resubmission. Unicycive has $61.4M in cash, supporting operations into 2H 2027.

Unicycive Therapeutics, Inc. (UNCY) filed an SEC Form 8-K — Other Events. Item 8.01 Other Events . On September 3, 2026, a securities class action lawsuit was filed in United States District Court for the Northern District of California against Unicycive Therapeutics, Inc. (the “Company”) and certain of its officers. This action alleges violations of t

Unicycive Therapeutics (NASDAQ:UNCY) shares rose about 2% premarket after it reported a Q2 loss of $0.06 per share versus a $0.48 consensus. Net loss was $1.7M, down from $6.5M, helped by $8.0M other income from warrant liability fair value changes. The FDA issued a Complete Response Letter for OLC, citing third-party manufacturing deficiencies; an inspection is scheduled and the company plans to resubmit. Cash: $61.4M, runway into 2027.