Unicycive Therapeutics presents OLC regulatory update with March 25, 2027 FDA decision target

PUBT · 1d ago
Unicycive Therapeutics presents OLC regulatory update with March 25, 2027 FDA decision target
  • 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.


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