NEW YORK, NY - August 20, 2025 (NEWMEDIAWIRE) - Kaplan Fox & Kilsheimer LLP announces that a class action lawsuit has been filed against Unicycive Therapeutics, Inc. (“Unicycive” or the “Company”) (NASDAQ: UNCY) on behalf of investors that purchased or otherwise acquired Unicycive securities between March 29, 2024 and June 27, 2025, both dates inclusive (the “Class Period”).
If you purchased Unicycive securities during the Class Period 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.
DEADLINE REMINDER: If you are a member of the proposed Class, you may move the court no later than October 14, 2025 to serve as a lead plaintiff for the purported class. If you have losses we encourage you to contact us to learn more about the lead plaintiff process. You need not seek to become a lead plaintiff in order to share in any possible recovery.
On June 10, 2025, before the market opened, Unicycive issued a press release announcing an “update on its New Drug Application (NDA) for oxylanthanum carbonate (OLC) to treat hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis.” The press release stated that the U.S. Food and 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.
Then, on June 30, 2025, Unicycive issued a press release announcing that it received a Complete Response Letter from the FDA for the OLC NDA. The CRL cited previously identified cGMP deficiencies at the third-party subcontractor of its CDMO.
On this news, the price of Unicycive stock fell nearly 30% on June 30, 2025.
The complaint alleges, among other things, that throughout the Class Period, Defendants made false and/or misleading statements and/or failed to disclose that: (i) Unicycive's readiness and ability to satisfy the FDA's manufacturing compliance requirements was overstated; and (ii) the OLC NDA's regulatory prospects were likewise overstated.
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If you have any questions about this Notice, your rights, or your interests, 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
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.
https://www.kaplanfox.com/case/unicycive-therapeutics-inc/
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