Kaplan Fox & Kilsheimer LLP is Investigating Unicycive Therapeutics, Inc. (UNCY) for Potential Securities Law Violations
CLICK HERE TO RECEIVE MORE INFORMATION ABOUT THIS INVESTIGATION
If you are an Unicycive investor and have suffered losses, you may CLICK HERE to contact us. You may also contact Kaplan Fox by emailing [email protected] or by calling (212) 329-8571.
On June 10, 2025, before the market opened, Unicycive issued a press release announcing an 'update on its New Drug Application (NDA) for oxlanthanum carbonate (OLC) to treat hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis.' Hyperphosphatemia is a medical condition that effects over 450,000 individuals annually and 'occurs in nearly all patients with End Stage Renal Disease', 'requir[ing] medication to control their phosphate levels.' The Company revealed that the Federal Drug Administration ('FDA') 'identified deficiencies in cGMP compliance at a third-party manufacturing vendor following an FDA inspection.'
Following this news, the price of Unicycive stock fell $3.68 per share, over 40%, to close at $5.32 per share on June 10, 2024 on heavy trading volume.
Then, on June 30, 2025, Unicycive announced receipt of a Complete Response Letter for OLC for the treatment of hyperphosphatemia in patients with CKD on dialysis (the 'CRL'), thereby indicating that the agency denied approval of the Company's NDA in its current form. The Company stated that the CRL 'cited deficiencies previously identified at a third-party manufacturing vendor. . . ' and that it has requested a meeting with the FDA.
Following this news, the price of Unicycive stock fell over 25% during intraday trading on June 30, 2025 on heavy trading volume.
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If you have any questions about this investigation, please contact:
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KAPLAN FOX & KILSHEIMER LLP
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Oakland, California 94612
(415) 772-4704
[email protected]
Contacting or submitting information to Kaplan Fox & Kilsheimer LLP does not create an attorney-client relationship, nor an obligation on the part of Kaplan Fox to retain you as a client.
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