Unicycive's annual report warned only that the FDA "could ask us to supplement our submissions," while a securities class action alleges the Company never disclosed that it had not inspected the third-party manufacturer whose unresolved cGMP deficiencies triggered a second Complete Response Letter and a 39.1% single-day loss for UNCY shareholders.
NEW YORK, Sept. 14, 2026 (GLOBE NEWSWIRE) -- Levi & Korsinsky, LLP notifies investors in Unicycive Therapeutics, Inc. (NASDAQ: UNCY) that a securities class action has been filed on behalf of shareholders who purchased securities between December 29, 2025 and June 29, 2026. Submit your information now. You may also contact Joseph E. Levi, Esq. at jlevi@levikorsinsky.com or (212) 363-7500.
On June 30, 2026, UNCY shares fell $3.01, or 39.1%, to close at $4.69 per share on unusually heavy trading volume, down from a Class Period high of $8.56 per share reached on May 14, 2026. The deadline to apply for lead plaintiff appointment is November 2, 2026.
What the Company Disclosed: SEC Filing Language on Regulatory Compliance
SEC filings stated that "[o]btaining clearances or approvals from the FDA and from the regulatory agencies in other countries is an expensive and time-consuming process and is uncertain as to outcome," and that "[i]f the third party fails inspection again or if the NDA is rejected again, we will need to make another NDA submission and our target PDUFA target action date will be extended by another 6-12 months." The same annual report described an October 2025 Type A meeting held to discuss "resolution of the single deficiency identified in the CRL related to the compliance status of a third-party manufacturing vendor."
What Plaintiffs Allege Was Missing From the Risk Disclosures
Disclosure Gaps Alleged:
- No disclosure that the Company had not inspected the vendor's facility, or otherwise audited its compliance with current good manufacturing practices, before the December 2025 resubmission
- No disclosure that management's characterization of "significant progress" toward regaining FDA compliance rested on vendor discussions rather than verified inspection results
- No disclosure of the risk that the FDA would require additional information about the vendor facility's manufacturing practices, the complaint charges
- Disclosure language indicated the OLC review "remains on track" for the June 29, 2026 PDUFA target action date without disclosing that approval was reasonably likely to be delayed
- Statements about an unaudited cash position of $41.3 million and a cash runway into 2027 were tied to a launch timeline the lawsuit contends lacked a reasonable basis
Regulatory Reality Behind the Second Complete Response Letter
On June 30, 2026, Unicycive announced that the FDA had issued a Complete Response Letter on the resubmitted NDA based on the "same third-party manufacturing deficiencies that were identified in the previous CRL issued in June 2025." The Company further stated that the FDA "has not yet conducted its inspection of that third-party manufacturing vendor as part of the review process," and that the resubmission had been made based on Unicycive's "belief of continued progress" by the vendor. The complaint challenges whether that unverified premise was adequately disclosed to purchasers.
"Generic risk factor language cannot substitute for disclosing specific, known problems that are already affecting a company's operations. The complaint alleges that shareholders were never told the manufacturing deficiency at the center of the OLC review had not been verified as resolved through Unicycive's own inspection." -- Joseph E. Levi, Esq.
Find out if you might qualify to recover losses or call (212) 363-7500.
WHY LEVI & KORSINSKY: Over the past 20 years, Levi & Korsinsky LLP has established itself as a nationally-recognized securities litigation firm that has secured hundreds of millions of dollars for aggrieved shareholders and built a track record of winning high-stakes cases. The firm has extensive expertise representing investors in complex securities litigation and a team of over 70 employees to serve our clients. For seven years in a row, Levi & Korsinsky has ranked in ISS Securities Class Action Services' Top 50 Report as one of the top securities litigation firms in the United States.
Frequently Asked Questions About the UNCY Lawsuit
Q: What specific misstatements does the UNCY lawsuit allege? A: The complaint alleges Unicycive Therapeutics made materially false or misleading statements regarding the compliance status of its third-party manufacturing vendor and the likelihood of timely FDA approval of oxylanthanum carbonate during the Class Period. When the Company disclosed a second Complete Response Letter citing the same third-party manufacturing deficiencies, the stock price declined sharply.
Q: What court was the UNCY class action filed in? A: The case was filed in the United States District Court for the Northern District of California, governed by the Private Securities Litigation Reform Act of 1995.
Q: Who are the defendants named in the UNCY lawsuit? A: The complaint names Unicycive Therapeutics, Inc. and individual defendants including senior executives who signed SEC filings, made public statements, or certified financial disclosures under Sarbanes-Oxley.
Q: What do UNCY investors need to do right now? A: Investors may gather brokerage records showing purchase dates, share quantities, and prices paid. Submit your information for a no-cost, no-obligation evaluation of your potential recovery. No immediate action is required to remain eligible as an absent class member.
Q: What is a lead plaintiff and why does it matter? A: A lead plaintiff is the investor appointed by the court to represent the entire class. Lead plaintiffs are typically investors with the largest documented losses. Being appointed does not increase individual recovery but gives direct oversight of how the case is run.
Q: What if I already sold my UNCY shares -- can I still recover losses? A: Yes. Eligibility is based on when you purchased, not whether you still hold the shares. Investors who bought during the Class Period and sold at a loss may still be eligible to participate.
Q: What does it cost me to participate? A: There is no upfront cost to submit your information and review whether you may be eligible to recover. Should you choose to participate in the securities class action, they are generally handled on a contingency basis, with any attorneys' fees and expenses subject to court approval.
Q: What if I live outside the United States? A: U.S. securities class actions generally cover purchases on U.S. exchanges regardless of the investor's country of residence.
CONTACT:
Levi & Korsinsky, LLP
Joseph E. Levi, Esq.
Ed Korsinsky, Esq.
33 Whitehall Street, 27th Floor
New York, NY 10004
jlevi@levikorsinsky.com
Tel: (212) 363-7500
Fax: (212) 363-7171
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