• Unicycive Therapeutics’ resubmitted oxylanthanum carbonate application is under FDA review, with a March 25, 2027, target action date.
• The resubmission includes manufacturing data from a new third-party vendor, which completed 12-month stability studies.
• A shorter approval timeline could be sought if the original manufacturing vendor passes an FDA inspection for manufacturing compliance.
• Cash runway extends into the second half of 2027.
• Launch preparations for the hyperphosphatemia treatment include sales force planning, reimbursement support and commercial logistics.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Unicycive Therapeutics Inc. published the original content used to generate this news brief on November 12, 2026, and is solely responsible for the information contained therein.