Boston, Massachusetts--(Newsfile Corp. - September 29, 2026) - Block & Leviton reminds investors that a securities fraud lawsuit has been filed against Unicycive Therapeutics, Inc. (NASDAQ: UNCY) and certain of its executives. Investors who have lost money in their Unicycive Therapeutics investment should contact the firm to learn more about how they might recover those losses. For more details, visit https://blockleviton.com/cases/uncy.

What is this all about?

On June 30, 2026, Unicycive Therapeutics disclosed that the FDA had issued a second Complete Response Letter, declining to approve OLC based on the same manufacturing deficiencies identified a year earlier. The company also stated that it understood the FDA had not yet inspected the manufacturer's facility during its review of the resubmitted application. On this news, Unicycive's stock fell approximately 39%.

The class action alleges that Unicycive Therapeutics and certain of its executives misled investors about the prospects for FDA approval of its drug candidate, OLC. According to the complaint, the company had not inspected its third-party manufacturer's facility or audited its compliance with manufacturing standards, leaving it without a reasonable basis to believe previously identified FDA deficiencies had been resolved. The lawsuit alleges that Unicycive failed to disclose the resulting risk of further regulatory delays.

Who is eligible?

Anyone who purchased or otherwise acquired Unicycive Therapeutics securities between December 29, 2025, and June 29, 2026, and suffered losses may be eligible to participate, whether or not they have sold their investment. Investors should contact Block & Leviton to learn more.

What should you do next?

The deadline to seek appointment as lead plaintiff is November 2, 2026. A class has not yet been certified, and until a certification occurs, you are not represented by an attorney. If you choose to take no action, you can remain an absent class member. If you've lost money on your investment, you should contact Block & Leviton to learn more via our case website, by email at shareholders@blockleviton.com, or by phone at (888) 256-2510.

Whistleblower?

If you have non-public information about Unicycive Therapeutics, you should consider assisting in our investigation or working with our attorneys to file a report with the Securities Exchange Commission under their whistleblower program. Whistleblowers who provide original information to the SEC may receive rewards of up to 30% of any successful recovery. For more information, contact Block & Leviton at whistleblowers@blockleviton.com or by phone at (888) 256-2510.

Why should you contact Block & Leviton?

Block & Leviton is widely regarded as one of the leading securities class action firms in the country. Our attorneys have recovered billions of dollars for defrauded investors and are dedicated to obtaining significant recoveries on behalf of our clients through active litigation in the federal courts across the country. Many of the nation's top institutional investors hire us to represent their interests. You can learn more about us at our website, www.blockleviton.com, call (888) 256-2510 or email shareholders@blockleviton.com with any questions.

This notice may constitute attorney advertising.

To view the source version of this press release, please visit https://www.newsfilecorp.com/release/316602

Source: Block & Leviton LLP