#USA #New York #Securities Law #Faruqi & Faruqi #Unicycive

Unicycive Therapeutics Under Legal Scrutiny

In a recent announcement, Faruqi & Faruqi, LLP, a well-recognized law firm specializing in securities litigation, has initiated an investigation into Unicycive Therapeutics, Inc. The firm is particularly focusing on claims from investors who sustained losses exceeding $50,000 due to the company’s alleged misleading practices related to their FDA compliance and regulatory processes.

Background of the Investigation

The investigation stems from significant allegations that Unicycive and its executives have breached federal securities laws through false statements and omissions regarding the company's ability to meet FDA manufacturing standards. Unicycive is known for developing treatments for chronic kidney disease and had made several bold claims regarding its pipeline products, specifically the New Drug Application (NDA) for its lead drug, OLC.

On June 10, 2025, Unicycive's stock plummeted by 40.89% within a single day after the company disclosed that the FDA discovered deficiencies in the compliance of a third-party manufacturing vendor. This disclosure raised serious questions about the company’s previous assertions of its operational readiness and capability to satisfy FDA requirements.

Recent Developments

Further compounding investor concerns, Unicycive's stock encountered another setback when it announced on June 30, 2025, that it had received a Complete Response Letter from the FDA, which effectively halted discussions on any label changes, further evidenced by cited non-compliance issues. Following this announcement, the stock price dropped an additional 29.85%.

As a result, many investors have faced serious financial losses and are now assessing their legal options. Faruqi & Faruqi is encouraging affected parties to take action before the October 14, 2025 deadline to seek designation as lead plaintiff in the impending class action lawsuit against Unicycive.

Importance of Legal Representation

Investors who suffered losses exceeding the $50,000 mark between March 29, 2024, and June 27, 2025, are particularly urged to reach out to Faruqi & Faruqi for guidance on navigating this complex legal landscape. James (Josh) Wilson, a partner at the firm, is leading this effort and is keen to discuss potential legal remedies with affected investors.

Faruqi & Faruqi is illustrating its commitment to ensuring that investors are protected and have the opportunity to recoup their losses through class action litigation. The firm’s history of securing hundreds of millions for investors since its inception in 1995 positions it as a formidable advocate in the realm of securities law.

Final Thoughts

Investors are advised to stay informed and take proactive steps to engage in the class action process or to contact the law firm for more personalized legal advice. For those who may have any inside information on Unicycive’s practices, including whistleblowers or former employees, are also encouraged to come forward to assist in the ongoing investigation.

For further information regarding this investigation or to discuss your legal rights, please contact Faruqi & Faruqi's New York office or visit their website at www.faruqilaw.com/UNCY.