Shamis & Gentile, P.A. is investigating claims on behalf of investors of Unicycive Therapeutics, Inc. (“Unicycive Therapeutics” or the “Company”) (UNCY). Impacted investors are advised to contact the firm now.
The investigation focuses on events surrounding a press release issued by Unicycive Therapeutics on June 10, 2025, before the market opened. In the release, the Company announced an update regarding its New Drug Application for oxlanthanum carbonate (OLC), a treatment for hyperphosphatemia in patients with chronic kidney disease on dialysis. The Company disclosed that the U.S. Food and Drug Administration (FDA) had communicated deficiencies in current good manufacturing practice (cGMP) compliance at a third-party manufacturing vendor following an FDA inspection. The FDA indicated that, due to these deficiencies, any label discussions between the FDA and the Company were precluded at that time.
On this news, Unicycive Therapeutics’s stock price fell as much as $0.43 per share, or over 47%, during intraday trading on June 10, 2025, on unusually heavy volume.
The investigation is evaluating whether Unicycive Therapeutics made misleading statements or omitted material information regarding its manufacturing processes, regulatory compliance, or the status of its NDA for OLC.
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