Unicycive Therapeutics presents OLC regulatory update with March 25, 2027 FDA decision target
Bitget2026/11/02 20:52- 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: 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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