Aug. 12 at 7:54 PM
Unicycive Therapeutics, Inc. (Nasdaq:
$UNCY ) announced in its second quarter 2026 business update that the U.S. Food and Drug Administration has assigned a facility inspection to the third-party manufacturing vendor for oxylanthanum carbonate (OLC), its investigational phosphate binding agent for hyperphosphatemia in patients with chronic kidney disease on dialysis.
Unicycive Therapeutics, Inc. is a B2i Digital (@B2iDigital) Featured Company. See the company’s in-depth profile at: https://b2idigital.com/unicycive
The second quarter update sets out the next step in the OLC regulatory pathway and the cash position behind it:
• The company expects to resubmit the New Drug Application for OLC assuming completion of a successful inspection of that vendor
• Unaudited cash, cash equivalents and marketable securities totaled
$61.4 million as of June 30, 2026, with expected runway into 2027
• The FDA has not raised any concerns regarding clinical efficacy or safety data for OLC, and requested no additional data
• Commercial readiness work continues, focused on patient access and the UniSource reimbursement hub
Regarding the inspection, Shalabh Gupta, M.D., Chief Executive Officer of Unicycive, stated: “The latest update from our third-party manufacturing vendor is that the U.S. Food and Drug Administration (FDA) has assigned a facility inspection. This marks a positive step forward, and our dialogue with the FDA on OLC labeling and packaging has been productive and continuous throughout this process.”
Read the full release: https://ir.unicycive.com/news/detail/124/unicycive-therapeutics-announces-second-quarter-2026
The company will engage the patient and clinical community at the 51st Annual American Association of Kidney Patients National Patient Meeting in Little Rock, Arkansas, September 11 to 13, and the 2026 Renal Healthcare Association Annual Conference in Savannah, Georgia, September 23 to 26.
Unicycive Therapeutics is a biotechnology company developing novel treatments for kidney diseases. Its lead investigational treatment is oxylanthanum carbonate, a novel phosphate binding agent for the treatment of hyperphosphatemia in patients with chronic kidney disease who are on dialysis. A second investigational treatment, UNI-494, is intended for conditions related to acute kidney injury, has been granted orphan drug designation by the FDA for the prevention of Delayed Graft Function in kidney transplant patients, and has completed a Phase 1 dose-ranging safety study in healthy volunteers. Learn more at https://unicycive.com.
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David Shapiro, Chief Executive Officer of B2i Digital, personally purchased in the open market and currently owns shares of unrestricted UNCY stock, in line with B2i Digital’s practice of investing alongside its Featured Companies. See the complete Disclosure at https://b2idigital.com/disclaimer. B2i Digital is not a broker-dealer or investment adviser.
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