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Shareholders who lost money in shares of Unicycive Therapeutics, Inc. (NASDAQ: UNCY) Should Contact Wolf Haldenstein Immediately.
UnicyciveUnicycive(US:UNCY) Prnewswireยท2025-08-21 11:05

Core Viewpoint - A securities class action lawsuit has been filed against Unicycive Therapeutics, Inc. for alleged violations of the Securities Exchange Act of 1934, specifically regarding misleading statements made by the company and its officers during the class period from March 29, 2024, to June 7, 2025 [1][2]. Company Summary - The lawsuit claims that Unicycive and certain officers made false and misleading statements about the company's readiness to meet FDA manufacturing compliance requirements and the regulatory prospects of its lead drug candidate, oxylanthanum carbonate (OLC) [2][4]. - Key events impacting the company's stock include: - Submission of the New Drug Application (NDA) for OLC to the FDA in September 2024 [4]. - Disclosure of deficiencies in cGMP compliance at a third-party manufacturing subcontractor on June 10, 2025, leading to a 40.9% stock drop to $5.32 [4]. - Issuance of a Complete Response Letter (CRL) by the FDA rejecting the OLC NDA due to cGMP issues on June 30, 2025, resulting in a further 29.9% stock decline to $4.77 [4]. - Investors must seek lead plaintiff appointment by October 14, 2025 [4].