Unicycive Therapeutics lost 39.1 per cent of its market value in one session. The stock fell $3.01 to close at $4.69 on June 30, 2026, the day the company disclosed that the FDA had issued a second Complete Response Letter on its resubmitted application for oxylanthanum, a kidney disease therapy.
The FDA letter, the company said, identified “the same third-party manufacturing deficiencies that were identified in the previous CRL issued in June 2025.”
A securities class action followed against Unicycive (NASDAQ: UNCY). It covers investors who purchased or acquired the company’s securities between December 29, 2025, and June 29, 2026.
What the complaint alleges
The plaintiffs say the company and its executives made false statements or hid several facts. They allege Unicycive had not inspected its third-party manufacturer’s facility, and had not audited whether the plant met current good manufacturing practices. That left it without a reasonable basis, the complaint says, to believe the vendor had fixed the deficiencies the FDA cited.
It also alleges an undisclosed risk that the FDA would ask for more information about the facility’s manufacturing practices. Approval of oxylanthanum, which the filings call OLC, was therefore reasonably likely to be delayed. The positive statements the company made about its business and prospects were, in the plaintiffs’ words, materially misleading or lacked a reasonable basis.
Deadline
Investors who want to serve as lead plaintiff must file a motion with the court by November 2, 2026. The lead plaintiff is the investor with the largest financial interest in the relief sought. Law firms Faruqi & Faruqi and Levi & Korsinsky have both issued notices about the case. One of them, Faruqi, notes that investors do not have to take that role to share in any recovery.
Sources
- UNCY ALERT: Securities Fraud Class Action Launched Against Unicycive Therapeutics, Inc. – November 2, 2026 Deadline
- UNCY DEADLINE ALERT: Faruqi & Faruqi, LLP Reminds Unicycive Therapeutics (NASDAQ: UNCY) Investors of Securities Class Action Lawsuit Deadline on November 2, 2026 – AOL
