Unicycive Therapeutics presents OLC regulatory update with March 25, 2027 FDA decision target
UNCY•The FDA is reviewing Unicycive Therapeutics’ resubmitted OLC application, with a decision target of March 25, 2027. Cash runway extends into the second half of 2027, and 91% of 78 patients entering maintenance in the pivotal study achieved phosphate control.
1. FDA review and timing
The FDA is reviewing Unicycive Therapeutics’ resubmitted application for OLC, with a target decision date of March 25, 2027. A shorter approval timeline could be sought if the original third-party manufacturer passes an FDA inspection for manufacturing compliance.
2. Study and preparations
In the pivotal study, 91% of 78 patients entering maintenance achieved phosphate control, and no treatment-related serious adverse events occurred. The company said its cash runway extends into the second half of 2027, commercial launch preparations are underway, and OLC targets a U.S. hyperphosphatemia market exceeding $1 billion.
