A securities class action alleges Unicycive Therapeutics leaned on a contract manufacturer already cited by the FDA for cGMP deficiencies, without verifying the vendor’s compliance status, before the same deficiencies triggered a second Complete Response Letter and a 39.1% single-day collapse in UNCY shares.
NEW YORK, Sept. 15, 2026 (GLOBE NEWSWIRE) — SueWallSt notifies investors in Unicycive Therapeutics, Inc. (NASDAQ: UNCY) that a class action has been filed on behalf of shareholders who purchased securities between December 29, 2025 and June 29, 2026. Find out if you might qualify for recovery. You may also contact Joseph E. Levi, Esq. at [email protected] or (888) SueWallSt.
UNCY shares fell $3.01, or 39.1%, to close at $4.69 on June 30, 2026, on unusually heavy volume, down from a Class Period high of $8.56 reached on May 14, 2026. Motions for lead plaintiff must be filed with the Court by November 2, 2026.
A Drug Company With No Manufacturing Facilities of Its Own
Unicycive does not manufacture oxylanthanum carbonate (OLC). It depends entirely on outside contract manufacturers, and in June 2025 the FDA issued a Complete Response Letter for the OLC New Drug Application citing cGMP deficiencies at the third-party manufacturing vendor of its main CDMO. The action contends that the Company resubmitted the NDA in December 2025 while continuing to rely on that same previously cited vendor.
The Alleged Contract Manufacturing Oversight Gap
As pleaded, Unicycive never inspected or audited the vendor’s facility for cGMP compliance, and therefore lacked a reasonable basis to believe the FDA’s cited deficiencies had been resolved. On June 30, 2026, the Company announced a second CRL resting on the “same third-party manufacturing deficiencies that were identified in the previous CRL issued in June 2025,” and stated the FDA had not conducted its inspection of the vendor during the resubmission review.
Alleged Manufacturing Dependency Impact by the Numbers
- June 2025: first CRL cites cGMP deficiencies at the third-party manufacturing vendor; no clinical, preclinical, or safety concerns raised
- December 2025: NDA resubmitted based on what the Company later described as its “belief” of continued vendor progress
- January 29, 2026: FDA accepts the resubmission as a Class II response and sets a PDUFA target action date of June 29, 2026
- June 30, 2026: second CRL announced, resting on the identical vendor deficiencies
- Company risk factor language warned that another failed inspection would extend the PDUFA target action date by another 6 to 12 months
- Unicycive reported an unaudited cash position of $41.3 million as of December 31, 2025, with runway into 2027
“A company that relies on outside manufacturers still owes investors an accurate account of what it has verified,” said Joseph E. Levi, Esq. “The complaint alleges Unicycive told the market its vendor had progressed toward compliance without having inspected the facility itself.”
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Frequently Asked Questions About the UNCY Lawsuit
Q: How much did UNCY stock drop? A: Shares fell approximately 39.1%, a decline of $3.01 per share, after the Company disclosed that the FDA issued a second Complete Response Letter based on the same third-party manufacturing deficiencies cited in the June 2025 CRL. Investors who purchased shares during the Class Period at artificially inflated prices and suffered losses may be eligible to seek compensation.
Q: What specific misstatements does the UNCY lawsuit allege? A: The complaint alleges Unicycive Therapeutics, Inc. made materially false or misleading statements regarding its third-party manufacturing vendor’s progress toward regaining FDA compliance and the likelihood of timely OLC approval during the Class Period. When the second Complete Response Letter was disclosed, the stock price declined sharply.
Q: When did Unicycive Therapeutics allegedly mislead investors? A: The Class Period runs from December 29, 2025 to June 29, 2026. The complaint alleges that corrective disclosures revealed information that caused a significant stock decline.
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: How long will the lawsuit take to resolve? A: Securities class actions typically take two to four years from initial filing to resolution. Timing depends on the court schedule, case developments, and whether the matter is dismissed, settled, or litigated further.
CONTACT:
Levi & Korsinsky, LLP
Joseph E. Levi, Esq.
33 Whitehall Street, 27th Floor
New York, NY 10004
[email protected]
Tel: (888) SueWallSt
Fax: (212) 363-7171
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