UNCY UPCOMING DEADLINE: Levi & Korsinsky Alerts Unicycive Therapeutics, Inc. Stockholders of Securities Class Action - Contact the Firm

A securities class action alleges Unicycive Therapeutics never inspected or audited its third-party manufacturer's facility for cGMP compliance before resubmitting the OLC New Drug Application, exposing shareholders to a second Complete Response Letter and a $3.01 per-share single-day loss.

NEW YORK, Oct. 7, 2026 /PRNewswire/ -- Levi & Korsinsky, LLP notifies investors in Unicycive Therapeutics, Inc. (NASDAQ: UNCY) that a class action lawsuit has been filed on behalf of shareholders who purchased securities between December 29, 2025 and June 29, 2026. Find out if you could qualify to recover your losses. You may also contact Joseph E. Levi, Esq. at [email protected] or (212) 363-7500.

UNCY shareholders absorbed a single-session loss of $3.01 per share, a decline of 39.1% on unusually heavy volume, after the June 30, 2026 announcement that the FDA had issued a second Complete Response Letter for oxylanthanum carbonate (OLC) citing the same third-party manufacturing deficiencies flagged in the first CRL of June 2025. Applications to serve as lead plaintiff must be filed by November 2, 2026.

The Alleged cGMP Compliance Verification Gap Behind the Securities Fraud Claims

The original CRL identified a single obstacle to approval: a contract manufacturing vendor cited for failing to adhere to current good manufacturing practices. Unicycive resubmitted its 505(b)(2) NDA in December 2025 and told the market the resubmission rested on the vendor's progress toward regaining FDA compliance and demonstrating inspection readiness.

The complaint alleges the Company had not inspected that vendor's facility, nor otherwise audited it for cGMP compliance, and therefore lacked a reasonable basis to represent that the FDA's cited deficiencies had been resolved. The June 30 announcement stated the resubmission had been made based on Unicycive's "belief" of continued progress, and that the FDA had not yet conducted its inspection of the vendor during the review cycle.

Key cGMP Compliance Allegations for Shareholders

• The lawsuit contends the Company never independently verified the vendor's remediation of previously identified cGMP deficiencies.
• The second CRL was based on the same manufacturing deficiencies identified roughly one year earlier, according to the lawsuit.
• The FDA raised no concerns regarding OLC's clinical efficacy or safety data and requested no additional data.
• Company risk disclosures acknowledged that a repeat inspection failure would extend the PDUFA target action date by another 6 to 12 months.
• The complaint alleges the undisclosed verification gap made a delay in OLC's regulatory approval reasonably likely.

"This case presents important questions about manufacturing compliance disclosure obligations in the biotechnology sector, where a single contract vendor can determine whether an approval proceeds. The complaint alleges investors were told a resubmission reflected verified progress that the Company had not independently confirmed." -- Joseph E. Levi, Esq.

Submit your information here 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: Who is eligible to join the UNCY investor lawsuit? A: Investors who purchased UNCY stock or securities between December 29, 2025 and June 29, 2026 and suffered financial losses may be eligible. Eligibility is based on purchase date and documented losses, not on whether you still hold the shares.

Q: What is the UNCY lead plaintiff deadline? A: The deadline to apply for lead plaintiff appointment is November 2, 2026. This deadline applies only to investors seeking to serve as lead plaintiff. Class members who do not apply may still participate in any recovery without taking action before this date.

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 resubmitted 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: 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: 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.

CONTACT:\
Levi & Korsinsky, LLP\
Joseph E. Levi, Esq.\
Ed Korsinsky, Esq.\
33 Whitehall Street, 27th Floor\
New York, NY 10004\
[email protected]\
Tel: (212) 363-7500\
Fax: (212) 363-7171

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SOURCE Levi & Korsinsky, LLP