Unicycive Therapeutics faces a securities fraud class action over claims it concealed that it never audited a manufacturing vendor whose unresolved deficiencies led the FDA to reject its kidney-disease drug a second time. The stock dropped 39.1 percent to $4.69 on June 30, 2026, after the agency issued a Complete Response Letter.
A securities fraud class action filed against Unicycive Therapeutics follows a 39 percent stock plunge triggered by the FDA's second rejection of its kidney-disease drug.
"Companies have an obligation to provide investors with complete and accurate information so that markets can function fairly and efficiently," Brian J. Robbins, founding partner of Robbins LLP, said.
Glancy Prongay Wolke & Rotter LLP filed the suit in the US District Court for the Northern District of California as Patel v. Unicycive Therapeutics Inc., Case No. 25-cv-09559, on behalf of investors who bought Unicycive securities between Dec. 29, 2025 and June 29, 2026. The complaint pursues claims under Sections 10(b) and 20(a) of the Securities Exchange Act of 1934.
Unicycive shares fell $3.01, or 39.1 percent, to close at $4.69 on June 30, 2026, on unusually heavy volume after the company disclosed the FDA had issued a Complete Response Letter on its resubmitted new drug application for oxylanthanum carbonate, citing the "same third-party manufacturing deficiencies" flagged in a June 2025 CRL.
The complaint alleges Unicycive submitted the NDA for OLC, a therapy for kidney disease, in September 2024, and the FDA accepted it in November 2024. After the first CRL cited deficiencies at a third-party manufacturing vendor, Unicycive held a Type A meeting with the FDA in October 2025 and resubmitted the application in December 2025.
Plaintiffs allege Unicycive never inspected or audited the vendor's facility for compliance with current good manufacturing practices, leaving the company without a reasonable basis to believe the cited deficiencies were resolved. Unicycive also failed to disclose the risk that the FDA would require more information about the vendor's practices and that approval of OLC was reasonably likely to be delayed, according to the complaint.
The class action is one of several investor notices tied to the same allegations, with Robbins LLP separately informing shareholders of their rights. Investors who bought Unicycive securities during the class period have 60 days from the notice to move the court to serve as lead plaintiff; Robbins LLP represents clients on a contingency fee basis.
The litigation adds legal and reputational pressure on a small-cap clinical-stage biotech that has yet to win approval for its lead candidate. The court's appointment of a lead plaintiff, expected in the coming months, will determine how the securities claims proceed and whether Unicycive faces settlement costs that could strain its balance sheet.
This article is for informational purposes only and does not constitute investment advice.
