Unicycive resubmits FDA NDA for oxylanthanum carbonate phosphate binder

Bitget2026/09/29 11:05

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Unicycive resubmitted its FDA NDA for oxylanthanum carbonate to treat hyperphosphatemia in CKD patients on dialysis.
Filing includes CMC data from a new manufacturing vendor, supporting FDA review with a new PDUFA date expected in six months.
Prior CRLs in June 2025 and June 2026 cited third-party manufacturing deficiencies; FDA raised no clinical efficacy or safety issues.

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 via GlobeNewswire (Ref. ID: 202609290705PRIMZONEFULLFEED9835664) on September 29, 2026, and is solely responsible for the information contained therein.

Disclaimer: The content of this article solely reflects the author's opinion and does not represent the platform in any capacity. This article is not intended to serve as a reference for making investment decisions.

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Unicycive resubmits FDA NDA for oxylanthanum carbonate phosphate binder

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