Unicycive Therapeutics presents OLC review update with March 25, 2027 FDA target action date
UNCY•UNCY•UNCY•UNCY•Unicycive Therapeutics said its resubmitted oxylanthanum carbonate application is under FDA review, with a March 25, 2027 target action date. The company said cash runway extends into the second half of 2027.
Unicycive Therapeutics said its resubmitted oxylanthanum carbonate application is under FDA review, with a March 25, 2027 target action date. The resubmission includes manufacturing data from a new third-party vendor that completed 12-month stability studies; the company said it could seek a shorter approval timeline if its original manufacturing vendor passes an FDA inspection for manufacturing compliance.
The company said its cash runway extends into the second half of 2027 and that preparations for a potential launch of the hyperphosphatemia treatment include sales force planning, reimbursement support and commercial logistics.
