Unicycive publishes corporate presentation highlighting OLC NDA review ahead of June 29 PDUFA date

Reuters04-02
Unicycive publishes corporate presentation highlighting OLC NDA review ahead of June 29 PDUFA date
  • Unicycive highlighted oxylanthanum carbonate (OLC) as lead program for hyperphosphatemia in chronic kidney disease patients on dialysis, with NDA resubmission under FDA review.
  • FDA assigned June 29, 2026 PDUFA date for OLC following acceptance of resubmission tied to remediation at third-party manufacturing vendor.
  • Company positioned OLC for potential launch, citing priorities in market awareness, reimbursement access, commercial operations.
  • Presentation cited hyperphosphatemia as US market opportunity above $1 billion, with more than 550,000 US dialysis patients.
  • Unicycive projected cash runway into 2027 to support OLC review, potential approval, launch preparations.


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