By Colin Kellaher
Unicycive Therapeutics shares plummeted in premarket trading Tuesday after the U.S. Food and Drug Administration once again turned away the clinical-stage biotechnology company's proposed oxylanthanum carbonate kidney-disease treatment due to issues at a contract manufacturer.
Shares of the Los Altos, Calif., company, which closed Monday at $7.70, were recently down 46% to $4.15 in premarket action.
Unicycive said the FDA has issued another so-called complete response letter regarding its resubmitted application for oxylanthanum carbonate for the treatment of hyperphosphatemia in patients with chronic kidney disease who are on dialysis, indicating the agency won't approve the application in its current form.
Unicycive said the FDA cited the same deficiencies at the outside manufacturer that the agency had identified when it rejected the company's initial application for its lead product candidate.
The company late last year said the vendor had made significant progress toward regaining FDA compliance, and that it had resubmitted its application.
However, Unicycive on Tuesday said FDA hasn't yet conducted an inspection of the manufacturing vendor as part of the review process of the resubmitted application.
Unicycive noted that the FDA hasn't raised any concerns regarding clinical efficacy or safety data, nor has it requested any additional data from the company.
Unicycive said it is in active talks with the FDA regarding the label and packaging for oxylanthanum carbonate. The company said it is optimistic there will be a successful inspection of the manufacturing vendor, and that it will be able to expeditiously resubmit its application.
Write to Colin Kellaher at colin.kellaher@wsj.com