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]

Core Viewpoint - A class action securities lawsuit has been filed against Unicycive Therapeutics, Inc. for 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 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 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 a leading securities litigation firm in the U.S. [4].

Core Viewpoint - Faruqi & Faruqi, LLP is investigating potential claims against Unicycive Therapeutics, Inc. due to alleged violations of federal securities laws, particularly concerning 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 Claims - The law firm 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 a federal securities class action against Unicycive [4][9]. - The complaint alleges that Unicycive and its executives made false and misleading statements regarding the company's readiness to meet FDA manufacturing compliance requirements [6][8]. Group 2: Stock Price Impact - Following a press release on June 10, 2025, regarding FDA deficiencies at a third-party manufacturing vendor, Unicycive's stock price fell by $3.68 per share, or 40.89%, closing at $5.32 [7]. - On June 30, 2025, after the FDA issued a Complete Response Letter for the OLC NDA, citing the same cGMP deficiencies, the stock price dropped by $2.03 per share, or 29.85%, closing at $4.77 [8]. Group 3: Company Background - Unicycive Therapeutics, Inc. is publicly traded on NASDAQ under the ticker UNCY [4]. - Faruqi & Faruqi, LLP has a history of recovering hundreds of millions of dollars for investors since its founding in 1995 [5].

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 overstated [2]. - The defendants' public statements are claimed to have been materially false and misleading throughout the relevant period [2]. Group 2: Investor Information - 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, and there are no out-of-pocket costs for class members [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 is notifying shareholders of Unicycive Therapeutics, Inc. about a class action lawsuit due to alleged misleading statements regarding the company's compliance with FDA manufacturing requirements and the regulatory prospects of its new drug application [1][3]. Group 1: Allegations - The complaint alleges that during the class period from March 29, 2024, to June 27, 2025, Unicycive overstated its readiness to meet FDA manufacturing compliance requirements [3]. - It is claimed that the regulatory prospects of the oxylanthanum carbonate new drug application were also overstated [3]. - As a result, the public statements made by the defendants were materially false and misleading throughout the relevant time [3]. Group 2: Class Action Details - Shareholders who purchased shares of UNCY during the specified class period are encouraged to register for the class action, with a deadline set for October 14, 2025 [4]. - Once registered, shareholders will be enrolled in a portfolio monitoring software to receive updates on the case [4]. - There is no cost or obligation for shareholders to participate in this case [4]. Group 3: Law Firm Information - The Gross Law Firm is a nationally recognized class action law firm dedicated to protecting the rights of investors affected by 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 - The complaint against Unicycive alleges violations of federal securities laws due to false or misleading statements regarding the company's compliance with FDA manufacturing requirements and the regulatory prospects of its OLC NDA [2]. Group 1: Company Performance and Regulatory Issues - On June 10, 2025, Unicycive announced that the FDA identified deficiencies in cGMP compliance at a third-party manufacturing vendor, leading to a significant stock price drop of $3.68 per share, or 40.89%, closing at $5.32 [3]. - On June 30, 2025, Unicycive disclosed that the FDA issued a Complete Response Letter for the OLC NDA, citing the same cGMP deficiencies, resulting in a further stock price decline of $2.03 per share, or 29.85%, closing at $4.77 [4]. Group 2: Legal Proceedings - The lead plaintiff in the class action lawsuit is the investor with the largest financial interest in the relief sought, who will oversee the litigation on behalf of the class [5]. - Any member of the putative class can move to serve as lead plaintiff or remain an absent class member without affecting their ability to share in any recovery [5]. Group 3: Whistleblower Information - The law firm Faruqi & Faruqi encourages individuals with information regarding Unicycive's conduct, including whistleblowers and former employees, to come forward [6].

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: Next Steps for Shareholders - Shareholders are encouraged to register for the class action by October 14, 2025, to potentially become lead plaintiffs [2]. - Registered shareholders will receive updates through a portfolio monitoring software throughout the case lifecycle [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].