“With a continued commitment to advancing OLC, we are poised to resubmit the NDA for OLC by the end of the year, following positive discussions with the FDA and our third-party manufacturing vendor,” said Shalabh Gupta, M.D., Chief Executive Officer of Unicycive. “Our focus has always been on enhancing the lives of people with hyperphosphatemia, as evidenced by the promising new data presented at ASN Kidney Week 2025 that showcase OLC’s differentiated clinical profile and reduced pill burden compared to currently available phosphate binders. With a cash runway into 2027, we are well positioned to complete the regulatory approval process and prepare for the potential launch of OLC next year, marking significant progress in advancing our mission to deliver improved treatment options for patients on dialysis.”
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