Core Insights - Unicycive Therapeutics plans to resubmit its New Drug Application (NDA) for Oxylanthanum Carbonate (OLC) by year-end 2025 after receiving constructive feedback from the FDA regarding a previously identified deficiency [1][2] - The company has over $42 million in cash as of September 30, 2025, providing a financial runway into 2027 to support regulatory processes and potential commercialization of OLC [2] - OLC is an investigational oral phosphate binder designed to treat hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis, leveraging proprietary nanoparticle technology for improved patient adherence [3][4] Company Overview - Unicycive Therapeutics is focused on developing novel treatments for kidney diseases, with OLC as its lead investigational treatment for hyperphosphatemia [6] - The company is also developing UNI-494, aimed at treating conditions related to acute kidney injury, which has received orphan drug designation from the FDA [6] Product Details - OLC utilizes proprietary nanoparticle technology to enhance phosphate binding potency, potentially reducing the pill burden for patients compared to existing treatments [3] - The NDA submission for OLC is based on data from three clinical studies and multiple preclinical studies, with a strong global patent portfolio protecting its composition until at least 2031, with potential extensions until 2035 [3] Market Context - Hyperphosphatemia is a critical condition affecting nearly all patients with End Stage Renal Disease (ESRD), with over 450,000 individuals in the U.S. requiring medication annually to manage phosphate levels [4]

Core Viewpoint - A class action lawsuit has been filed against Unicycive Therapeutics, Inc. on behalf of shareholders who purchased securities during the specified class period from March 29, 2024, to June 27, 2025 [1] Company Summary - Unicycive Therapeutics, Inc. is identified as a clinical-stage biotechnology company [1] - The lawsuit is being investigated by Rosen Law Firm, a global investor rights law firm [1]

Core Viewpoint - Rosen Law Firm is reminding investors who purchased Unicycive Therapeutics, Inc. securities during the class period from March 29, 2024, to June 27, 2025, about the lead plaintiff deadline of October 14, 2025, for a class action lawsuit [1][2]. Group 1: Class Action Details - Investors may be entitled to compensation without any out-of-pocket fees through a contingency fee arrangement [1]. - A class action lawsuit has already been filed, and interested parties must move the Court to serve as lead plaintiff by the specified deadline [2]. - The lawsuit alleges that Unicycive made false and misleading statements regarding its compliance with FDA manufacturing requirements and the regulatory prospects of its New Drug Application [4]. Group 2: Rosen Law Firm's Credentials - Rosen Law Firm has a strong track record in securities class actions, having achieved the largest settlement against a Chinese company at the time and being ranked No. 1 for securities class action settlements in 2017 [3]. - The firm has recovered hundreds of millions of dollars for investors, securing over $438 million in 2019 alone [3]. - Founding partner Laurence Rosen was recognized as a Titan of Plaintiffs' Bar by Law360 in 2020, highlighting the firm's expertise and recognition in the field [3].

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: Class Action Details - The class period for the lawsuit is from March 29, 2024, to June 27, 2025 [3]. - Allegations include that Unicycive overstated its readiness to meet FDA manufacturing compliance and the regulatory prospects of its oxylanthanum carbonate new drug application [3]. - The deadline for shareholders to register for the class action is October 14, 2025 [4]. Group 2: Next Steps for Shareholders - Shareholders who register will be enrolled in a portfolio monitoring software for status updates throughout the case [4]. - There is no cost or obligation for shareholders to participate in the case [4]. Group 3: Law Firm Background - The Gross Law Firm is a nationally recognized class action law firm focused on 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].

Group 1 - A federal securities class action has been filed against Unicycive Therapeutics, Inc. (NASDAQ: UNCY) [1] - Faruqi & Faruqi, LLP is investigating potential claims related to the company [1] - Investors are reminded of the October 14, 2025 deadline to seek the role of lead plaintiff in the class action [1]

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 investors who 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 alleges 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 claims that Unicycive assured investors of its ability to satisfy FDA requirements but failed to disclose deficiencies identified by the FDA at a third-party manufacturing vendor [8] - Following the announcement of these deficiencies on June 10, 2025, Unicycive's stock price fell over 40% [8] - On June 30, 2025, the FDA issued a Complete Response Letter for the NDA, resulting in a further stock price drop of 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 Bragar Eagel & Squire, P.C. for more information [4] - The law firm offers no cost or obligation for consultations regarding the lawsuit [4]

Core Viewpoint - Rosen Law Firm is reminding investors who purchased Unicycive Therapeutics, Inc. securities during the specified class period of the upcoming lead plaintiff deadline on October 14, 2025 [1]. Group 1: Class Action Details - Investors who bought Unicycive securities between March 29, 2024, and June 27, 2025, may be eligible for compensation without any out-of-pocket fees through a contingency fee arrangement [2]. - A class action lawsuit has already been filed, and interested parties can join by contacting Rosen Law Firm [3][6]. - The lead plaintiff must file a motion with the court by October 14, 2025, to represent other class members in the litigation [3]. Group 2: Law Firm Credentials - Rosen Law Firm emphasizes the importance of selecting qualified legal counsel with a proven track record in securities class actions, highlighting its own success in this area [4]. - The firm has achieved significant settlements, including the largest securities class action settlement against a Chinese company at the time, and has consistently ranked highly in terms of settlements since 2013 [4]. - In 2019, the firm secured over $438 million for investors, showcasing its capability in recovering funds for clients [4]. Group 3: Case Allegations - The lawsuit alleges that Unicycive's management made false or misleading statements regarding the company's compliance with FDA manufacturing requirements and the regulatory prospects of its New Drug Application for oxylanthanum carbunate [5]. - It is claimed that these misrepresentations led to investor damages when the true information became public [5].

Core Viewpoint - Faruqi & Faruqi, LLP is investigating potential claims against Unicycive Therapeutics, Inc. due to allegations of 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 [3][5]. Group 1: Legal Investigation and Class Action - The firm is reminding investors of the October 14, 2025 deadline to seek the role of lead plaintiff in a federal securities class action against Unicycive [3]. - Investors who suffered losses in Unicycive between March 29, 2024, and June 27, 2025, are encouraged to contact the firm to discuss their legal rights [1][3]. Group 2: Allegations Against Unicycive - The complaint alleges that Unicycive and its executives made false and misleading statements regarding the company's ability to meet FDA manufacturing compliance requirements and the 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 stock price drop of $3.68 per share, or 40.89%, closing at $5.32 [6]. - Following a Complete Response Letter from the FDA on June 30, 2025, citing the same cGMP deficiencies, Unicycive's stock fell by $2.03 per share, or 29.85%, closing at $4.77 [7].

Group 1: Unicycive Therapeutics - A shareholder class action lawsuit has been filed against Unicycive Therapeutics, alleging that the company made materially false and/or misleading statements regarding its ability to meet FDA manufacturing compliance requirements between March 29, 2024, and June 27, 2025 [1] - Investors who purchased Unicycive shares during this period and suffered significant losses are encouraged to discuss their legal rights [1] Group 2: KinderCare Learning Companies - A shareholder class action lawsuit has been filed against KinderCare Learning Companies, claiming that the company made materially false and/or misleading statements in the Registration Statement related to its October 2024 IPO regarding the quality of care at its facilities [2] - Investors who purchased KinderCare shares in connection with the October 2024 IPO and experienced significant losses are encouraged to discuss their legal rights [2] Group 3: Holzer & Holzer, LLC - Holzer & Holzer, LLC is a top-rated securities litigation law firm that focuses on representing shareholders and investors in litigation, including class action and derivative litigation [3] - The firm has been involved in recovering hundreds of millions of dollars for shareholders affected by fraud and corporate misconduct since its founding in 2000 [3]

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 investors who 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 compliance at a third-party manufacturing 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] - The firm emphasizes that there is no cost or obligation for investors to inquire about their rights [4]