NEW YORK, NY - June 10, 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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If you are a Unicycive investor and have suffered losses, you may CLICK HERE to contact us. You may also contact Kaplan Fox by emailing jcampisi@kaplanfox.com 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.” The press release stated that the U.S. Federal Drug Administration (“FDA”) “communicated to the Company that it had identified deficiencies in cGMP compliance at a third-party manufacturing vendor (one of its CDMO’s third-party subcontractors and not its Drug Substance vendor) following an FDA inspection. The FDA indicated that, given the identified deficiencies, any label discussions between the FDA and the Company are precluded. The Company has responded to all FDA information requests and expects a final decision from the FDA by the PDUFA action date of June 28, 2025.”
Following this news, the price of Unicycive stock fell as much as $0.43 per share, over 47%, during intraday trading on June 10, 2025 on unusually heavy 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 1560
Oakland, California 94612
(415) 772-4704
lking@kaplanfox.com
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https://www.kaplanfox.com/case/unicycive-therapeutics-inc/
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