Unicycive Therapeutics, Inc. Class Action: Robbins LLP Investigates Allegations of Misleading Investors Regarding Drug Prospect.

A class action lawsuit has been filed against Unicycive Therapeutics, Inc. alleging that the company misled investors about its drug prospects and manufacturing compliance. The lawsuit claims that Unicycive overstated its readiness and ability to satisfy the FDA's manufacturing compliance requirements. The company's stock price fell significantly after the FDA issued a Complete Response Letter for the OCL NDA. Investors who purchased or acquired Unicycive securities between March 29, 2024, and June 27, 2025, may be eligible to participate in the class action.

A class action lawsuit has been filed against Unicycive Therapeutics, Inc. (UNCY) alleging that the company misled investors about its drug prospects and manufacturing compliance. Robbins LLP, a recognized leader in shareholder rights litigation, has informed stockholders that a class action was filed on behalf of investors who purchased or otherwise acquired Unicycive securities between March 29, 2024, and June 27, 2025.

The lawsuit claims that Unicycive overstated its readiness and ability to satisfy the U.S. Food and Drug Administration's (FDA) manufacturing compliance requirements. According to the complaint, Unicycive touted the prospects of its New Drug Application (NDA) for oxylanthanum carbonate (OLC) for the treatment of hyperphosphatemia in chronic kidney disease patients on dialysis. However, it failed to disclose that its readiness and ability to meet the FDA's manufacturing compliance requirements were overstated.

On June 10, 2025, Unicycive announced that the FDA had identified deficiencies in current good manufacturing practice (cGMP) compliance at a third-party manufacturing vendor following an FDA inspection. This announcement led to a significant drop in Unicycive's stock price, falling over 40%. Then, on June 30, 2025, Unicycive announced that the FDA had issued a Complete Response Letter (CRL) for the OLC NDA, citing the previously identified cGMP deficiencies. This news caused Unicycive's stock to fall almost 30%, closing at $4.77 per share on June 30, 2025.

Investors who purchased or acquired Unicycive securities during the specified period may be eligible to participate in the class action. Shareholders who wish to serve as lead plaintiff for the class should contact Robbins LLP before the October 14, 2025, deadline to move for lead plaintiff. The lead plaintiff acts on behalf of other class members in directing the litigation.

Unicycive has requested a Type A meeting with the FDA to discuss resolution of the CRL received in June. The company believes it has multiple approaches to correct the deficiency noted for its third-party manufacturing vendor, which was unrelated to OLC. The recently published pivotal trial data in the Clinical Journal of the American Society of Nephrology (CJASN) demonstrated that OLC was well tolerated and enabled serum phosphate control in over 90% of patients with a low pill burden.

Unicycive ended the second quarter of 2025 with $22.3 million in cash, providing sufficient resources to fund operations into the second half of 2026. The company remains committed to meeting the clear need for improved treatment options for managing hyperphosphatemia in dialysis patients.

References:
[1] https://www.prnewswire.com/news-releases/investor-alert-robbins-llp-informs-investors-of-the-unicycive-therapeutics-inc-class-action-302531560.html
[2] https://finance.yahoo.com/news/unicycive-therapeutics-announces-second-quarter-110000771.html