NEW YORK, Aug. 27, 2025 (GLOBE NEWSWIRE) -- The Gross Law Firm issues the following notice to shareholders of Unicycive Therapeutics, Inc. (NASDAQ: UNCY). Shareholders who purchased shares of UNCY during the class period listed are encouraged to contact the firm regarding possible lead plaintiff appointment. Appointment as lead plaintiff is not required to partake in any recovery. CONTACT US HERE: https://securitiesclasslaw.com/securities/unicycive-therapeutics-inc-loss-submission-form/?id=163682&from=3 CLA ...

LOS ALTOS, Calif., Aug. 26, 2025 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease (the “Company” or “Unicycive”), today announced that Shalabh Gupta, M.D., Chief Executive Officer will participate in two investor events in September. Event: H.C. Wainwright 27th Annual Global Investment Conference Type: Fireside chatDate/Time: Wednesday, September 10, 2025, at 8:30 a.m. ET Event: Truist Securities Vir ...

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 - 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 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].

Company Overview - Unicycive Therapeutics, Inc. is a clinical-stage biotechnology company focused on developing therapies for kidney diseases [5] - The company's lead investigational treatment is oxylanthanum carbonate, aimed at treating hyperphosphatemia in chronic kidney disease patients on dialysis [5] - The second investigational drug, UNI-494, is intended for treating conditions related to acute kidney injury and has received orphan drug designation from the FDA for preventing Delayed Graft Function in kidney transplant patients [5] Intellectual Property - The U.S. Patent and Trademark Office has issued U.S. Patent 12,377,082 for UNI-494, ensuring intellectual property protection until 2040 [1] - This patent complements an earlier method of use patent for UNI-494 in treating Acute Kidney Injury [1] - The patent portfolio for UNI-494 supports potential partnership opportunities and future development efforts [2] Product Development - UNI-494 is a novel nicotinamide ester derivative that acts as a selective ATP-sensitive mitochondrial potassium channel activator, addressing mitochondrial dysfunction in kidney diseases [3] - The drug has completed a Phase 1 dose-ranging safety study in healthy volunteers [3] - The company is currently focused on seeking FDA approval for its lead product, oxylanthanum carbonate [2] Acute Kidney Injury Context - Acute kidney injury (AKI) is characterized by a sudden loss of kidney function, with primary causes including sepsis, ischemia, and drug-induced nephrotoxicity [4] - AKI affects 20-200 per million in the community, 7-18% of hospitalized patients, and approximately 50% of ICU patients [4] - An estimated 2 million people die from AKI globally each year, with survivors at increased risk for chronic kidney disease and end-stage renal disease [4]

Core Points - Unicycive Therapeutics has regained compliance with Nasdaq's minimum share price requirement following a reverse stock split [1][2] - The company's common stock maintained an average closing share price of at least $1.00 as of July 3, 2025, after the 1:10 reverse stock split effective June 20, 2025 [2] Company Overview - Unicycive Therapeutics is focused on developing novel treatments for kidney diseases [3] - The lead investigational treatment is oxylanthanum carbonate, currently under FDA review for treating hyperphosphatemia in chronic kidney disease patients on dialysis [3] - 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 [3]

Company Overview - Unicycive Therapeutics, Inc. is a clinical-stage biotechnology company focused on developing therapies for kidney disease [3] - The company's lead investigational treatment is oxylanthanum carbonate, a phosphate binding agent for treating hyperphosphatemia in chronic kidney disease patients on dialysis [3] - Unicycive's 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 [3] Upcoming Events - Shalabh Gupta, M.D., CEO of Unicycive, will participate in a fireside chat at the H.C. Wainwright 4th Annual Kidney Virtual Conference on July 14, 2025, at 11 a.m. ET [1] - A link to the webcast of the event will be available on the Unicycive website under the Investors section [2]

Core Viewpoint - Unicycive Therapeutics, Inc. is implementing a 1-for-10 reverse stock split to comply with Nasdaq's minimum bid price requirement, effective June 18, 2025, with trading on a split-adjusted basis starting June 20, 2025 [1][2]. Group 1: Reverse Stock Split Details - The reverse stock split will combine every ten shares into one, reducing the number of issued shares from approximately 126,409,281 to about 12,640,929 [4]. - Stockholders will not receive fractional shares; instead, fractional interests will be rounded up to the next whole share [3]. - The reverse stock split will not affect stockholders' percentage ownership or voting power, except for minor changes due to fractional shares [3]. Group 2: Compliance and Adjustments - The reverse stock split aims to increase the bid price of the common stock to meet the $1.00 minimum bid price requirement for continued listing on Nasdaq [2]. - Proportionate adjustments will be made to the exercise prices and number of shares underlying stock options, warrants, and preferred stock as a result of the reverse stock split [5]. Group 3: Company Overview - Unicycive Therapeutics is focused on developing therapies for kidney diseases, with its lead investigational treatment, oxylanthanum carbonate, under FDA review for treating hyperphosphatemia in chronic kidney disease patients on dialysis [8]. - The second investigational treatment, UNI-494, is aimed at conditions related to acute kidney injury and has received orphan drug designation from the FDA [9].

Company Overview - Unicycive Therapeutics, Inc. is a clinical-stage biotechnology company focused on developing therapies for kidney diseases [2] - The company'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] - Unicycive's 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] Upcoming Events - Shalabh Gupta, M.D., CEO of Unicycive, will present at the Lytham Partners Spring 2025 Investor Conference on May 29, 2025, at 12:30 p.m. ET [1] - The company will also participate in the Noble Capital Markets 2025 Emerging Growth Virtual Equity Conference on June 4, 2025, at 1 p.m. ET [1] - Live and archived webcasts of these presentations will be available on the Unicycive website under the Investors section [1]