• Unicycive Therapeutics’ OLC application resubmission is under FDA review, with a March 25, 2027, target decision date.
• A shorter approval timeline could be sought if the original third-party manufacturer passes an FDA inspection for manufacturing compliance.
• Cash runway extends into the second half of 2027.
• OLC targets a US hyperphosphatemia market exceeding $1 billion, with commercial launch preparations underway.
• In the pivotal study, 91% of 78 patients entering maintenance achieved phosphate control; no treatment-related serious adverse events occurred.

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 02, 2026, and is solely responsible for the information contained therein.