By Colin Kellaher
Unicycive Therapeutics shares lost nearly a third of their value on Tuesday after the clinical-stage biotechnology company said its bid to win U.S. Food and Drug Administration approval for its proposed kidney-disease drug has hit a snag.
Shares of the Los Alto, Calif., company were recently down 31% at 62 cents.
Unicycive, which is seeking FDA approval of oxylanthanum carbonate for hyperphosphatemia in chronic kidney disease patients on dialysis, on Tuesday said the agency had found deficiencies at a third-party manufacturing vendor that preclude any label discussions between the FDA and the company.
Unicycive said it is working with its partners to help resolve the FDA's concerns, which it said involve one of its contract development and manufacturing organization's third-party subcontractors and not its drug substance vendor.
The company said it has responded to all FDA information requests, and that it expects a final decision from the agency by its June 28 target action date.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
06-10-25 1009ET
