A securities class action alleges Unicycive Therapeutics assured the market that its third-party manufacturer had made “significant progress” toward FDA compliance without ever inspecting the facility, and UNCY shares lost 39.1% of their value in a single session when a second Complete Response Letter was announced.

NEW YORK, Sept. 23, 2026 /PRNewswire/ — Levi & Korsinsky, LLP alerts 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. Find out if you may qualify to recover losses. You may also contact Joseph E. Levi, Esq. at jlevi@levikorsinsky.com or (212) 363-7500.

UNCY closed at $7.70 on June 29, 2026, the day before the disclosure; the Class Period high close was $8.56 per share on May 14, 2026. The following morning, shares fell $3.01, or 39.1%, to close at $4.69 on unusually heavy trading volume. To be considered for lead plaintiff, investors must file by November 2, 2026.

What the June 30, 2026 Announcement Told the Market

Before the opening bell on June 30, 2026, Unicycive announced that the FDA had issued a second Complete Response Letter for the resubmitted oxylanthanum carbonate New Drug Application, based on the “same third-party manufacturing deficiencies that were identified in the previous CRL issued in June 2025.” The Company also stated that the FDA had not yet conducted its inspection of that vendor during the resubmission review, and that the resubmission had rested on Unicycive’s “belief” of continued progress.

The lawsuit contends that the Company had never inspected or audited the vendor’s facility for cGMP compliance, and therefore lacked a reasonable basis for the confidence conveyed to investors during the six months leading to the June 29, 2026 PDUFA target action date.

The Numbers Behind the Selloff

• Class Period high close: $8.56 per share on May 14, 2026
• Single-session decline: $3.01 per share, or 39.1%, on June 30, 2026
• Closing price after the announcement: $4.69 per share
• Trading volume on the decline: characterized in the complaint as unusually heavy
• Company risk disclosures indicated that a repeat inspection failure or rejection would push the PDUFA target action date out another 6-12 months

Why the Market Reaction Matters to UNCY Purchasers

The complaint asserts that purchasers acquired shares at prices that did not reflect the unverified status of the vendor’s compliance, and that the June 30, 2026 announcement is what allegedly corrected those prior statements. Purchasers who bought during the Class Period and sold at a loss may still be eligible, because eligibility turns on the purchase date rather than continued ownership.

“A nearly 40% single-day decline on heavy volume is the kind of market reaction that warrants a close look at what investors were told beforehand,” said Joseph E. Levi, Esq. “Here the complaint alleges the Company projected confidence about a manufacturing vendor whose facility it had never inspected. Shareholders are entitled to have that question examined.”

Submit your information here or call (212) 363-7500.

ABOUT THE FIRM — For over two decades, Levi & Korsinsky has represented shareholders in securities class actions. Ranked in ISS Top 50 for seven consecutive years. Investors who suffered losses have until November 2, 2026 to seek appointment as lead plaintiff.

Frequently Asked Questions About the UNCY Lawsuit

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: 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 had issued a second Complete Response Letter for the OLC New Drug Application based on the same third-party manufacturing deficiencies identified in the prior CRL. Investors who purchased shares during the Class Period at artificially inflated prices and suffered losses may be eligible to seek compensation.

Q: When did Unicycive Therapeutics, Inc. 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 happens after I contact Levi & Korsinsky? A: An attorney will review your trading history at no cost and provide an initial assessment of your potential eligibility.

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: Do I need to go to court or give testimony? A: No. The overwhelming majority of class members never appear in court or give depositions. If there is a settlement or recovery, eligible class members generally submit a claim form to seek their portion.

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.

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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SOURCE Levi & Korsinsky, LLP