
UNCY SHAREHOLDER NOTICE: Faruqi & Faruqi, LLP Reminds Unicycive Therapeutics (UNCY) Investors of Securities Class Action Lawsuit Deadline on November 2, 2026
Newsfile Corp
Published: Sep 11, 2026, 01:53 PM
Sentiment Analysis
Faruqi & Faruqi, LLP , a leading national securities law firm, is investigating potential claims against Unicycive Therapeutics, Inc. ("" or the "Company") (NASDAQ: UNCY) and reminds investors of the November 2, 2026 deadline to seek the role of lead plaintiff in a federal securities class action that has been filed against the Company.
As detailed below, the complaint alleges that the Company and its executives violated federal securities laws by making false and/or misleading statements and/or failing to disclose that: (1) the Company had not inspected its third-party manufacturing vendor's facility or otherwise audited the facility's compliance with current good manufacturing practices; (2) that, as a result, the Company lacked a reasonable basis to believe that the vendor had resolved the FDA's cited deficiencies; (3) that there was an undisclosed risk that the FDA would require additional information about the vendor's facility's manufacturing practices; (4) that, as a result of the foregoing, the regulatory approval of OLC was reasonably likely to be delayed; and (5) that, as a result of the foregoing, Defendants' positive statements about the Company's business, operations, and prospects were materially misleading and/or lacked a reasonable basis.
On June 30, 2026, Unicycive disclosed that the FDA had issued a second Complete Response Letter ("CRL") regarding the Company's resubmitted New Drug Application for its kidney disease therapy, oxylanthanum, identifying the "same third-party manufacturing deficiencies that were identified in the previous CRL issued in June 2025."
On this news, Unicycive's stock price fell $3.01, or 39.1%, to close at $4.69 per share on June 30, 2026, thereby injuring investors.
The lawsuit alleges Unicycive misled investors about manufacturing compliance, unresolved FDA deficiencies, and regulatory risks that could delay approval of OLC.
Source: Newsfile Corp
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