Kaplan Fox Alerts Investors of Unicycive Therapeutics to an Investigation of Possible Securities Law Violations
CLICK HERE TO RECEIVE MORE INFORMATION ABOUT THIS INVESTIGATION
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 [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.' 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.
WHY CONTACT KAPLAN FOX - Kaplan Fox is a leading national law firm focusing on complex litigation with offices in New York, Oakland, Los Angeles, Chicago and New Jersey. With over 50 years of experience in securities litigation, Kaplan Fox offers the professional experience and track record that clients demand. Through prosecuting cases on the federal and state levels, Kaplan Fox has successfully shaped the law through winning many important decisions on behalf of our clients. For more information about Kaplan Fox & Kilsheimer LLP, you may visit our website at www.kaplanfox.com.
This press release may be considered Attorney Advertising in some jurisdictions under the applicable law and ethical rules.
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
[email protected]
Laurence D. King
KAPLAN FOX & KILSHEIMER LLP
1999 Harrison Street, Suite 1560
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.
https://www.kaplanfox.com/case/unicycive-therapeutics-inc/
View the original release on www.newmediawire.com
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