NEW YORK, NY - June 30, 2025 (NEWMEDIAWIRE) - Kaplan Fox & Kilsheimer LLP is investigating potential securities violations against Unicycive Therapeutics, Inc. (“Unicycive” or the “Company”) (NASDAQ: UNCY).
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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:
CONTACT:
Jeffrey P. Campisi
KAPLAN FOX & KILSHEIMER LLP
800 Third Avenue, 38th Floor
New York, New York 10022
(212) 329-8571
jcampisi@kaplanfox.com
Laurence D. King
KAPLAN FOX & KILSHEIMER LLP
1999 Harrison Street, Suite 1501
Oakland, California 94612
(415) 772-4704
lking@kaplanfox.com
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