#United States #New York #Pomerantz Law Firm #Unicycive Therapeutics #UNCY

In recent developments, Pomerantz LLP has initiated an investigation concerning Unicycive Therapeutics, Inc. (NASDAQ: UNCY) on behalf of its investors. The firm aims to determine if the company and specific officers or directors have engaged in any fraudulent activities or business practices that violate securities laws. This investigation comes in light of alarming news regarding Unicycive's New Drug Application (NDA) for its product aimed at treating hyperphosphatemia in patients suffering from chronic kidney disease (CKD) on dialysis. On June 30, 2025, Unicycive disclosed that the U.S. Food and Drug Administration (FDA) had sent a Complete Response Letter (CRL) regarding their NDA. The letter indicated that a manufacturing vendor associated with Unicycive had been cited for deficiencies following a cGMP (Current Good Manufacturing Practice) inspection. This communication from the FDA led to an immediate and significant drop in Unicycive's stock price; it fell by $2.03 per share, approximately 29.85%, closing at $4.77 per share on the same day. The ramifications of the FDA's response were profound, revealing potential vulnerabilities in the company’s operations and its ability to deliver on its promises to investors. Pomerantz LLP, recognized for its expertise in corporate, securities, and antitrust class actions, advocates for victims of securities fraud and corporate misconduct. With a well-established history of securing multi-million dollar settlements for class members, the firm is poised to address the grievances from investors affected by Unicycive's alleged missteps. Investors seeking further insight or interested in joining the class action are encouraged to reach out to Danielle Peyton at 646-581-9980, ext. 7980, or via email at [email protected] Unicycive, founded with a vision to innovate in drug development, now finds itself facing scrutiny from legal entities as it grapples with regulatory challenges. The fallout from these events highlights the delicate balance between pharmaceutical advancement and regulatory compliance, a theme that echoes throughout the industry. Unicycive’s management is expected to take immediate corrective actions to navigate these troubled waters wisely, not just to reassure investors but to restore confidence in its capabilities and future endeavors. As the investigation unfolds, the implications for Unicycive and its investors will be closely watched, emphasizing the importance of transparency and accountability within the biotechnology sector. Moving forward, Unicycive must address these issues strategically to mitigate further financial and reputational damage while striving to maintain its standing in the competitive landscape of therapeutic innovation. The situation warrants close attention, as both potential legal outcomes and operational responses will significantly shape the future trajectory of Unicycive Therapeutics and its market positioning. Investors are urged to stay informed and proactive in seeking clarity on how these developments may affect their stakes in the company.