Unicycive Therapeutics Faces Securities Class Action Lawsuit

Author: Evelyn Baker Updated: 08-20-2025 04:22 PM

Unicycive Therapeutics Under Legal Scrutiny

Unicycive Therapeutics, Inc. (NASDAQ: UNCY) is currently facing legal challenges following a securities class action lawsuit. This lawsuit has been initiated in the United States District Court for the Northern District of California and includes individuals and entities that purchased Unicycive's securities during the defined class period.

Details of the Lawsuit

The class action lawsuit was triggered by allegations of violations against the Securities Exchange Act of 1934, specifically Sections 10(b) and 20(a), along with SEC Rule 10b-5. Investors claim that both Unicycive and its officers provided false and misleading information regarding the company’s capabilities and statements about their lead drug candidate.

Understanding the Allegations

The heart of the allegations lies in claims that Unicycive misrepresented its readiness to comply with FDA manufacturing regulations. Investors are particularly distressed about the communication concerning the regulatory status of their lead drug candidate, oxylanthanum carbonate (OLC), which is aimed at treating hyperphosphatemia in chronic kidney disease patients undergoing dialysis.

Timeline of Key Events

Several critical events led to the current situation and significantly impacted the stock's performance:

September 2024: Unicycive submitted its New Drug Application (NDA) for OLC to the FDA.
June 10, 2025: The FDA revealed deficiencies in Current Good Manufacturing Practice (cGMP) compliance at a third-party manufacturer. Following this, Unicycive's stock plummeted by 40.9% to reach $5.32.
June 30, 2025: The FDA issued a Complete Response Letter (CRL) rejecting the OLC NDA primarily due to similar cGMP issues, causing the stock to fall an additional 29.9%, landing at $4.77.

Lead Plaintiff Applications

Investors impacted by these developments must take action, as the deadline to apply for lead plaintiff status is fast approaching.

The Importance of Legal Representation

Investors who feel their financial interests have been compromised due to misleading statements are encouraged to reach out to legal experts. Wolf Haldenstein Adler Freeman & Herz LLP is actively seeking to assist individuals affected by this situation, utilizing their extensive experience in securities litigation that spans over 125 years.

Contact Information

If you have been impacted or have information that may contribute to the ongoing investigation, please consider contacting Wolf Haldenstein:

Phone: (800) 575-0735 or (212) 545-4774
Email: classmember@whafh.com
Contact Person: Gregory Stone, Director of Case and Financial Analysis

Frequently Asked Questions

What is the basis for the lawsuit against Unicycive Therapeutics?

The lawsuit is based on allegations that Unicycive made false and misleading statements regarding its compliance with FDA regulations and the prospects of its lead drug candidate.

What must investors do to join the lawsuit?

Investors should contact Wolf Haldenstein to express their interest in joining the case and submit their contact information.

What are some key dates related to the case?

Key dates include the deadline for lead plaintiff application by October 14, 2025, and the significant drops in stock price documented following FDA communications.

What information will I need to provide?

You will need to provide your contact information and any information regarding your investment in Unicycive Therapeutics to aid in the investigation.

How can I contact the law firm?

You can reach out via phone or email provided above to discuss your circumstances and determine your eligibility to participate in the lawsuit.

About The Author

Greetings, I'm 32-year-old author and financial specialist Evelyn Baker. My introduction into the financial industry started with an economics degree and continued with a wealth of experience in wealth management and financial consulting. My great passion over the years has been assisting people and companies in making wise, well-informed decisions to reach their financial objectives.

My goal with writing is to simplify difficult financial ideas into understandable, doable guidance. My goal in writing many books and articles is to make personal finance understandable to everyone, irrespective of their experience or background. I want to give readers the information they need to take charge of their financial futures, from investing and retirement planning to budgeting and saving.

Along with my writing, I lead webinars and workshops where I provide doable advice and methods for achieving financial success. To reach a larger audience, I also frequently contribute to financial blogs and publications. My method is always to offer doable, real-world guidance that can actually improve people's lives.

Aside from my job, I like to cook, travel, and experience other cultures. I work hard to apply my belief in the value of a balanced life to my financial counsel. My goal in working is to encourage and enable people to succeed financially so they may lead the best lives possible.

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