By Colin Kellaher

Unicycive Therapeutics shares tumbled more than 20% in premarket trading Monday after the Food and Drug Administration turned away the company's proposed treatment for an electrolyte disorder in people with kidney disease due to issues at a contract manufacturer.

Unicycive, which was seeking approval of oxylanthanum carbonate to treat hyperphosphatemia in patients with chronic kidney disease on dialysis, said the FDA issued a so-called complete response letter, indicating the agency won't approve the clinical-stage biotechnology company's application in its current form.

Unicycive said the FDA cited deficiencies at a third-party manufacturing vendor of the company's main contract development and manufacturing organization that aren't related to oxylanthanum carbonate, adding that the agency didn't raise any concerns related to pre-clinical, clinical or safety data.

The Los Altos, Calif., company said it identified a second manufacturing vendor that has already produced oxylanthanum carbonate drug product, which it said could be used to support the resolution of the issues the FDA has raised, and that it plans to immediately request a meeting with the agency to determine its align on next steps.

Unicycive shares were recently down nearly 22% to $5.32 in premarket trading.

Write to Colin Kellaher at colin.kellaher@wsj.com

(END) Dow Jones Newswires

June 30, 2025 09:22 ET (13:22 GMT)

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