Unicycive says FDA has assigned facility inspection for OLC manufacturing vendor

Unicycive Therapeutics reported on August 12, 2026 that its third-party vendor has received written notification from the FDA that a facility inspection has been assigned, and the company plans to provide an update after the inspection is completed.¹ The company said it is optimistic about a successful inspection of the third-party manufacturing facility, which would allow it to promptly resubmit the NDA.¹

This follows a Complete Response Letter the company disclosed for the quarter: in June, Unicycive received a CRL from the FDA on the resubmitted NDA for OLC, aimed at treating hyperphosphatemia in chronic kidney disease patients on dialysis.¹ The CRL pointed to the same third-party manufacturing deficiencies flagged in a prior CRL from June 2025.¹ The company noted that the FDA has not raised concerns about clinical efficacy or safety data, and did not request additional data.¹

On the commercial side, Unicycive said it continues to build out commercial readiness for a potential OLC launch, including efforts to optimize patient access across reimbursement settings through its UniSource reimbursement hub.¹ The company also plans to attend two September conferences: the 51st Annual American Association of Kidney Patients National Patient Meeting in Little Rock, Arkansas, and the 2026 Renal Healthcare Association Annual Conference in Savannah, Georgia.¹

On finances, the company said as of June 30, 2026, unaudited cash, cash equivalents, and marketable securities totaled $61.4 million, with expected runway into 2027.¹

Separately, the company's second program, UNI-494, has orphan drug designation from the FDA for prevention of Delayed Graft Function in kidney transplant patients and has finished a Phase 1 dose-ranging safety study in healthy volunteers.¹