Unicycive Secures June 29 PDUFA Date for Oxylanthanum Carbonate NDA, Prepares Launch
Unicycive ended Q1 with $57.1 million in cash and equivalents, funding operations into 2027, and posted a $12.8 million loss ($0.54 per share) due to warrant liability revaluation. The FDA accepted its oxylanthanum carbonate NDA resubmission with a June 29, 2026 PDUFA date as the company advances launch preparations.
1. FDA Review and Launch Preparations
The FDA accepted the resubmitted NDA for oxylanthanum carbonate with a PDUFA target action date of June 29, 2026, following three clinical studies, multiple preclinical evaluations and CMC data reviews without raising safety or efficacy concerns. In anticipation of potential approval, Unicycive is bolstering its commercial infrastructure, including the UniSource™ reimbursement hub and dedicated patient access support services.
2. First Quarter Financial Results
As of March 31, 2026, Unicycive held $57.1 million in cash, cash equivalents and marketable securities, supporting operations into 2027. Q1 R&D and G&A expenses were $1.6 million and $6.8 million, respectively, and the company reported a $12.8 million net loss ($0.54 per share) driven primarily by warrant liability fair-value adjustments.