• Unicycive Therapeutics highlighted oxylanthanum carbonate (OLC) as lead program for hyperphosphatemia in chronic kidney disease patients on dialysis, with an FDA PDUFA date of June 29, 2026, following acceptance of an NDA resubmission.
• NDA resubmission followed a late 2025 Type A meeting focused on resolving a compliance deficiency tied to a third-party manufacturing vendor cited in a complete response letter.
• Presentation framed hyperphosphatemia as a US market opportunity of more than USD 1 billion, citing about 550,000 US dialysis patients with roughly 80% receiving phosphate binders.
• In OLC pivotal safety population (N=86), treatment-related adverse events occurring in at least 5% of patients were diarrhea at 9% and vomiting at 6%, with no treatment-related serious adverse events.
• Company projected cash runway into 2027 to support review, potential approval, and launch preparation, while advancing UNI-494 for acute kidney injury.

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 May 13, 2026, and is solely responsible for the information contained therein.