A securities class action contends Unicycive Therapeutics promised shareholders an FDA decision on June 29, 2026 and a commercial launch of oxylanthanum carbonate “later this year,” while allegedly never inspecting the third-party manufacturing facility that had already triggered one Complete Response Letter.

NEW YORK, Sept. 10, 2026 /PRNewswire/ — 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 could qualify to recover your per-share losses. You may also contact Joseph E. Levi, Esq. at jlevi@SueWallSt.com or (888) SueWallSt.

UNCY closed at $7.70 on June 29, 2026, the promised PDUFA target action date. One session later the stock closed at $4.69, a drop of $3.01 per share, or 39.1%, on unusually heavy trading volume. The lead plaintiff deadline is November 2, 2026.

The Promise

In January 2026, the company projected that the FDA had accepted the OLC resubmission and assigned a target action date of June 29, 2026, with management stating it was “advancing our commercial preparation activities in anticipation of a potential launch of OLC later this year.” In May 2026, the company projected that the review “remains on track,” citing an unaudited cash position of $41.3 million and a runway into 2027.

The Reality

On June 30, 2026, Unicycive announced a second Complete Response Letter based on the “same third-party manufacturing deficiencies that were identified in the previous CRL issued in June 2025.” That same announcement stated the FDA “has not yet conducted its inspection” of the vendor during the resubmission review, and that the resubmission had rested on the Company’s “belief” of continued progress.

Promise vs. Actual: By the Numbers

• Promised: a regulatory decision by the June 29, 2026 target action date. Actual: a second Complete Response Letter announced June 30, 2026.
• Promised: a potential OLC launch “later this year.” Actual: the Company’s own risk disclosure stated that another submission would extend the target action date by 6 to 12 months.
• Promised: a resubmission “based on the progress made by the third-party manufacturing vendor.” Actual: the identical deficiencies cited a year earlier, according to the June 30 announcement.
• Promised: $41.3 million in cash and runway into 2027 to complete the approval process. Actual: a pathway that results revealed would require a further resubmission.
• Share price gap: $7.70 on June 29, 2026 versus $4.69 on June 30, 2026.

What the Lawsuit Alleges About the Gap

The action alleges Unicycive never inspected or audited the vendor’s facility for cGMP compliance and therefore lacked a reasonable basis for its approval and launch projections. The gap demonstrates, plaintiffs allege, that shareholders paid prices reflecting a timeline the Company had not independently verified.

Companies that make specific promises to investors about future performance have an obligation to disclose known risks to those projections. Here the complaint alleges the Company represented that its OLC review was on track while never verifying, through its own inspection, that the vendor’s previously cited deficiencies had been resolved. — Joseph E. Levi, Esq.

Submit your information here or call (888) SueWallSt.

WHY SUEWALLST: SueWallSt is powered by Levi & Korsinsky LLP. 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 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 based on the same third-party manufacturing deficiencies identified in June 2025. 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 the FDA compliance status of its third-party manufacturing vendor and the expected timeline for OLC approval and launch during the Class Period. When the second Complete Response Letter was disclosed, the stock price declined sharply.

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

jlevi@SueWallSt.com

Tel: (888) SueWallSt

Fax: (212) 363-7171

Attorney Advertising. Prior results do not guarantee similar outcomes.

View original content to download multimedia:https://www.prnewswire.com/news-releases/uncy-shareholder-alert-investors-with-losses-may-seek-to-lead-the-class-action-in-unicycive-therapeutics-securities-lawsuit—contact-suewallst-302874903.html

SOURCE SueWallSt.com