The complaint filed by Glancy Prongay Wolke & Rotter LLP alleges that Unicycive Therapeutics failed to audit its third-party manufacturing vendor, leaving the company without a legitimate basis to claim that FDA-cited deficiencies had been resolved. According to the litigation, this oversight created an undisclosed risk that the FDA would demand further information regarding manufacturing practices, ultimately threatening the regulatory approval timeline for the drug OLC.

Because these operational risks remained hidden, the lawsuit contends that the company’s public statements regarding its business prospects were materially misleading. Investors seeking to participate in the recovery process must file a motion with the court before the November 2 deadline. While no class has been certified yet, those who purchased securities during the specified period retain the right to act as lead plaintiffs or remain as absent class members.