Core Viewpoint - Faruqi & Faruqi, LLP is investigating potential claims against Unicycive Therapeutics, Inc. due to allegations of violations of federal securities laws related to misleading statements about the company's compliance with FDA manufacturing requirements and the regulatory prospects of its New Drug Application (NDA) for OLC [4][6]. Group 1: Legal Investigation and Class Action - Faruqi & Faruqi is encouraging investors who suffered losses in Unicycive between March 29, 2024, and June 27, 2025, to discuss their legal rights [1][4]. - There is a deadline of October 14, 2025, for investors to seek the role of lead plaintiff in the federal securities class action against Unicycive [4][9]. - The firm has a history of recovering hundreds of millions of dollars for investors since its founding in 1995 [5]. Group 2: Allegations Against Unicycive - The complaint alleges that Unicycive and its executives made false and misleading statements regarding the company's readiness to meet FDA manufacturing compliance requirements and the prospects of the OLC NDA [6]. - On June 10, 2025, Unicycive disclosed deficiencies in cGMP compliance at a third-party manufacturing vendor, leading to a stock price drop of $3.68 per share, or 40.89%, closing at $5.32 [7]. - Following a Complete Response Letter from the FDA on June 30, 2025, citing the same cGMP deficiencies, Unicycive's stock price fell by $2.03 per share, or 29.85%, closing at $4.77 [8].

Core Viewpoint - A class action securities lawsuit has been filed against Unicycive Therapeutics, Inc. due to alleged securities fraud affecting investors between March 29, 2024, and June 27, 2025 [1][2]. Group 1: Lawsuit Details - The lawsuit claims that Unicycive overstated its readiness to meet FDA manufacturing compliance requirements [2]. - It is alleged that the regulatory prospects of the oxylanthanum carbonate new drug application were also overstated [2]. - Defendants' public statements are claimed to have been materially false and misleading throughout the relevant period [2]. Group 2: Next Steps for Investors - Investors who suffered losses during the specified timeframe have until October 14, 2025, to request appointment as lead plaintiff [3]. - Participation in the lawsuit does not require serving as a lead plaintiff to share in any potential recovery [3]. - Class members may be entitled to compensation without any out-of-pocket costs or fees [3]. Group 3: Firm Background - Levi & Korsinsky has a history of securing hundreds of millions of dollars for shareholders and has extensive expertise in complex securities litigation [4]. - The firm has been recognized in ISS Securities Class Action Services' Top 50 Report for seven consecutive years as one of the leading securities litigation firms in the U.S. [4].

Core Viewpoint - The Gross Law Firm has issued a notice to shareholders of Unicycive Therapeutics, Inc. regarding a class action lawsuit due to alleged misleading statements and failure to disclose critical information during the specified class period [1][2]. Group 1: Allegations and Class Period - The class period for the allegations is from March 29, 2024, to June 27, 2025 [1]. - Allegations include that Unicycive overstated its readiness to meet FDA manufacturing compliance requirements and the regulatory prospects of its oxylanthanum carbonate new drug application [1]. Group 2: Shareholder Actions - Shareholders who purchased shares during the class period are encouraged to register for the class action and can seek lead plaintiff status by the deadline of October 14, 2025 [2]. - Registered shareholders will receive updates through a portfolio monitoring software throughout the lifecycle of the case [2]. Group 3: Law Firm's Mission - The Gross Law Firm aims to protect investors' rights against deceit, fraud, and illegal business practices, ensuring companies adhere to responsible business practices [3].

Core Viewpoint - Unicycive Therapeutics, Inc. is facing a class action lawsuit due to allegations of issuing materially false and misleading statements regarding its compliance with FDA manufacturing requirements and the regulatory prospects of its new drug application [3][4]. Group 1: Allegations and Class Period - The class period for the lawsuit is defined as March 29, 2024, to June 27, 2025 [3]. - Allegations include overstating Unicycive's readiness to meet FDA manufacturing compliance and the regulatory prospects of its oxylanthanum carbonate new drug application [3]. Group 2: Shareholder Actions - Shareholders who purchased UNCY shares during the class period are encouraged to register for the class action, with a deadline set for October 14, 2025 [4]. - Registration allows shareholders to receive updates on the case through portfolio monitoring software [4]. Group 3: Law Firm Background - The Gross Law Firm is a nationally recognized class action law firm dedicated to protecting investors' rights against deceit and fraud [5]. - The firm aims to ensure companies adhere to responsible business practices and seeks recovery for investors who suffered losses due to misleading statements [5].

Core Viewpoint - A class action lawsuit has been filed against Unicycive Therapeutics, Inc. for alleged violations of federal securities laws during the Class Period from March 29, 2024, to June 27, 2025, related to misleading statements about the company's readiness for FDA compliance and the prospects of its New Drug Application for oxylanthanum carbonate [1][5]. Group 1: Lawsuit Details - The lawsuit is filed in the United States District Court Northern District of California, seeking damages for all persons and entities that purchased Unicycive securities during the Class Period [1]. - Investors have until October 14, 2025, to request to be appointed as Lead Plaintiff for the class [2]. Group 2: Company Overview - Unicycive is a clinical-stage biotechnology company focused on developing therapies for unmet medical needs, including oxylanthanum carbonate (OLC) for treating hyperphosphatemia in chronic kidney disease patients on dialysis [3]. Group 3: Allegations Against Defendants - Defendants allegedly made materially false and misleading statements regarding the company's business and compliance policies, overstating Unicycive's readiness to meet FDA manufacturing compliance requirements and the regulatory prospects of the OLC NDA [5]. - On June 10, 2025, Unicycive disclosed deficiencies in cGMP compliance at a third-party manufacturing vendor, leading to a significant stock price drop of 40.89% [6]. - Following the issuance of a Complete Response Letter (CRL) from the FDA on June 30, 2025, citing the same deficiencies, Unicycive's stock price fell an additional 29.85% [7].

NEW YORK, Aug. 26, 2025 /PRNewswire/ -- Levi & Korsinsky, LLP notifies investors in Unicycive Therapeutics, Inc. ("Unicycive Therapeutics, Inc." or the "Company") (NASDAQ: UNCY) of a class action securities lawsuit.CLASS DEFINITION: The lawsuit seeks to recover losses on behalf of Unicycive Therapeutics, Inc. investors who were adversely affected by alleged securities fraud between March 29, 2024 and June 27, 2025. Follow the link below to get more information and be contacted by a member of our team:https: ...

Core Insights - Unicycive Therapeutics, Inc. is a clinical-stage biotechnology company focused on developing therapies for kidney disease [1][2] - The company will participate in two investor events in September 2025, including the H.C. Wainwright 27th Annual Global Investment Conference and a Truist Securities Virtual Fireside Chat [1] Company Overview - Unicycive's lead investigational treatment is oxylanthanum carbonate, a phosphate binding agent under FDA review for treating hyperphosphatemia in chronic kidney disease patients on dialysis [2] - The second investigational treatment, UNI-494, targets conditions related to acute kidney injury and has received orphan drug designation from the FDA for preventing Delayed Graft Function in kidney transplant patients [2] - UNI-494 has completed a Phase 1 dose-ranging safety study in healthy volunteers [2]

Core Viewpoint - A class action securities lawsuit has been filed against Unicycive Therapeutics, Inc. due to alleged securities fraud affecting investors between March 29, 2024, and June 27, 2025 [1][2] Group 1: Lawsuit Details - The lawsuit claims that Unicycive overstated its readiness to meet FDA manufacturing compliance requirements [2] - It is also alleged that the regulatory prospects of the oxylanthanum carbonate new drug application were exaggerated [2] - Defendants' public statements are claimed to have been materially false and misleading throughout the relevant period [2] Group 2: Next Steps for Investors - Investors who suffered losses during the specified timeframe have until October 14, 2025, to request appointment as lead plaintiff [3] - Participation in the lawsuit does not require serving as a lead plaintiff to share in any potential recovery [3] - Class members may be entitled to compensation without incurring out-of-pocket costs or fees [3] Group 3: Firm Background - Levi & Korsinsky has a history of securing hundreds of millions of dollars for shareholders and has extensive experience in complex securities litigation [4] - The firm has been recognized in ISS Securities Class Action Services' Top 50 Report for seven consecutive years as a leading securities litigation firm in the U.S. [4]

Core Viewpoint - A class action lawsuit has been filed against Unicycive Therapeutics, Inc. and certain officers for alleged violations of federal securities laws during the Class Period from March 29, 2024, to June 27, 2025 [1][6]. Company Overview - Unicycive is a clinical-stage biotechnology company focused on developing therapies for unmet medical needs, including oxylanthanum carbonate (OLC) for treating hyperphosphatemia in chronic kidney disease (CKD) patients on dialysis [4]. Legal Proceedings - The lawsuit seeks to recover damages for investors who purchased Unicycive securities during the Class Period, alleging that the company made materially false and misleading statements regarding its business and compliance policies [1][6]. - Investors have until October 14, 2025, to request appointment as Lead Plaintiff in the class action [2]. Regulatory Issues - Throughout the Class Period, Unicycive's management allegedly overstated the company's readiness to meet FDA manufacturing compliance requirements and the regulatory prospects of the OLC New Drug Application (NDA) [6]. - On June 10, 2025, Unicycive disclosed deficiencies in cGMP compliance at a third-party manufacturing vendor, leading to a significant drop in stock price by $3.68 per share (40.89%) [7]. - Following this, on June 30, 2025, the FDA issued a Complete Response Letter for the OLC NDA, further impacting the stock price, which fell by $2.03 per share (29.85%) [8].

Core Points - A class action lawsuit has been filed against Unicycive Therapeutics, Inc. for alleged misrepresentation regarding its New Drug Application for oxylanthanum carbonate [8] - The lawsuit covers all individuals and entities that purchased Unicycive securities between March 29, 2024, and June 27, 2025, with a deadline of October 14, 2025, to apply as lead plaintiff [8] - The complaint claims that Unicycive overstated its readiness to meet FDA manufacturing compliance requirements, which led to significant stock price declines following negative FDA inspections [8] Allegation Details - The lawsuit alleges that Unicycive's management assured investors of the company's ability to satisfy FDA requirements, which was later revealed to be overstated [8] - On June 10, 2025, Unicycive disclosed that the FDA identified deficiencies in cGMP compliance at a third-party vendor, leading to a stock price drop of over 40% [8] - Following a Complete Response Letter from the FDA on June 30, 2025, citing the same deficiencies, Unicycive's stock fell nearly 30%, closing at $4.77 per share [8] Next Steps - Investors who suffered losses and wish to discuss their legal rights are encouraged to contact the law firm Bragar Eagel & Squire, P.C. for more information [4][5]