Core Viewpoint - A securities class action lawsuit has been filed against Unicycive Therapeutics, Inc. for alleged violations of the Securities Exchange Act of 1934, specifically regarding misleading statements made by the company and its officers during the class period from March 29, 2024, to June 7, 2025 [1][2]. Company Summary - The lawsuit claims that Unicycive and certain officers made false and misleading statements about the company's readiness to meet FDA manufacturing compliance requirements and the regulatory prospects of its lead drug candidate, oxylanthanum carbonate (OLC) [2][4]. - Key events impacting the company's stock include: - Submission of the New Drug Application (NDA) for OLC to the FDA in September 2024 [4]. - Disclosure of deficiencies in cGMP compliance at a third-party manufacturing subcontractor on June 10, 2025, leading to a 40.9% stock drop to $5.32 [4]. - Issuance of a Complete Response Letter (CRL) by the FDA rejecting the OLC NDA due to cGMP issues on June 30, 2025, resulting in a further 29.9% stock decline to $4.77 [4]. - Investors must seek lead plaintiff appointment by October 14, 2025 [4].

Core Viewpoint - A securities class action lawsuit has been filed against Unicycive Therapeutics, Inc. for alleged violations of the Securities Exchange Act of 1934, specifically regarding misleading statements about the company's FDA compliance and drug candidate prospects [1][2]. Summary by Relevant Sections Lawsuit Details - The lawsuit is on behalf of all individuals and entities who purchased Unicycive securities between March 29, 2024, and June 7, 2025 [1]. - Allegations include false statements regarding the company's readiness to meet FDA manufacturing compliance requirements [2]. - The suit also claims misleading information about the regulatory prospects of the lead drug candidate, oxylanthanum carbonate (OLC), for treating hyperphosphatemia in chronic kidney disease patients on dialysis [3]. Key Events - In September 2024, Unicycive submitted its New Drug Application (NDA) for OLC to the FDA [7]. - On June 10, 2025, the company disclosed that the FDA found deficiencies in cGMP compliance at a third-party manufacturing subcontractor, leading to a stock drop of 40.9% to $5.32 [7]. - On June 30, 2025, the FDA issued a Complete Response Letter (CRL) rejecting the OLC NDA due to the same cGMP issues, causing the stock to fall another 29.9% to $4.77 [7]. - Investors must seek lead plaintiff appointment by October 14, 2025 [7].

Core Viewpoint - A class action lawsuit has been filed against Unicycive Therapeutics, Inc. for alleged violations of federal securities laws during the specified class period [1][2]. Group 1: Lawsuit Details - The lawsuit seeks to recover damages for all individuals and entities that purchased Unicycive securities between March 29, 2024, and June 27, 2025 [2]. - The Complaint alleges that Unicycive's management made materially false and misleading statements regarding the company's business operations and compliance policies [3]. - Specific allegations include overstated readiness to meet FDA manufacturing compliance requirements and exaggerated regulatory prospects for the OLC NDA [3]. Group 2: Next Steps for Investors - Investors who suffered losses in Unicycive have until October 14, 2025, to request appointment as lead plaintiff in the case [4]. - Participation in any recovery does not require serving as lead plaintiff [4]. Group 3: Legal Representation - The law firm representing the investors operates on a contingency fee basis, meaning they will only collect fees if the case is successful [5]. - Bronstein, Gewirtz & Grossman, LLC has a history of recovering significant amounts for investors in securities fraud cases [6].

NEW YORK, Aug. 18, 2025 (GLOBE NEWSWIRE) -- Gainey McKenna & Egleston announces that a securities class action lawsuit has been filed in the United States District Court for the Northern District of California on behalf of all persons or entities who purchased or otherwise acquired Unicycive Therapeutics, Inc. ("Unicycive" or the "Company") (NASDAQ: UNCY) securities between March 29, 2024 and June 27, 2025, inclusive (the "Class Period"). The Complaint alleges that Defendants made false and/or misleading st ...

Core Points - Holzer & Holzer, LLC has initiated a shareholder class action lawsuit against Unicycive Therapeutics, alleging that the company made materially false and misleading statements regarding its FDA manufacturing compliance and the regulatory prospects of its OLC NDA [1] - The lawsuit claims that Unicycive overstated its readiness to meet FDA requirements and the likelihood of regulatory approval for its product [1] - Shareholders who purchased Unicycive shares between March 29, 2024, and June 27, 2025, are encouraged to contact the law firm for more information regarding their legal rights [2] Legal Context - The deadline for shareholders to request to be appointed as lead plaintiff in the case is October 14, 2025 [3] - Holzer & Holzer, LLC is recognized as a top-rated securities litigation law firm and has a history of recovering significant amounts for shareholders affected by corporate misconduct [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 Viewpoint - A class action has been filed against Unicycive Therapeutics, Inc. for allegedly misleading investors regarding the readiness of its drug application and compliance with FDA manufacturing requirements [1][2]. Group 1: Allegations and Legal Action - Robbins LLP is investigating allegations that Unicycive Therapeutics misled investors about the prospects of its New Drug Application (NDA) for oxylanthanum carbonate (OLC) [2]. - The complaint claims that Unicycive overstated its readiness to meet FDA manufacturing compliance requirements [2]. - Shareholders are encouraged to participate in the class action and can contact Robbins LLP before the October 14, 2025 deadline to serve as lead plaintiff [4]. Group 2: Stock Performance and FDA Actions - On June 10, 2025, Unicycive announced that the FDA identified deficiencies in cGMP compliance at a third-party manufacturing vendor, leading to a stock price drop of over 40% [3]. - Following the FDA's issuance of a Complete Response Letter for the OLC NDA on June 30, 2025, Unicycive's stock fell nearly 30%, closing at $4.77 per share [3].

Core Viewpoint - Unicycive Therapeutics is under investigation for possible securities fraud following a significant stock price decline after the FDA issued a Complete Response Letter for its New Drug Application [1][3][4] Company Summary - Unicycive Therapeutics, Inc. (NASDAQ: UNCY) has faced legal scrutiny as the Portnoy Law Firm has initiated an investigation into potential securities fraud and may file a class action on behalf of investors [1] - The company received a Complete Response Letter from the FDA regarding its New Drug Application for OLC, which is intended to treat hyperphosphatemia in patients with chronic kidney disease on dialysis [3] - The FDA's response was triggered by deficiencies found in a third-party manufacturing vendor during a cGMP inspection [3] Stock Performance - Following the FDA announcement, Unicycive's stock price fell by $2.03 per share, representing a decline of approximately 29.85%, closing at $4.77 per share on June 30, 2025 [4]

Exhibit 99.1 Unicycive Therapeutics Announces Second Quarter 2025 Financial Results and Provides Business Update LOS ALTOS, California, August 14, 2025 -- Unicycive Therapeutics, Inc. ("Unicycive" or the "Company") (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease, today announced its financial results for the three months ended June 30, 2025, and provided a business update. "Our team has made great progress in the second quarter and we have request ...

Core Insights - Unicycive Therapeutics has requested a Type A meeting with the FDA to address the Complete Response Letter (CRL) regarding oxylanthanum carbonate (OLC) [1][9] - Recent pivotal study data published in the Clinical Journal of the American Society of Nephrology indicates that OLC was well tolerated and achieved serum phosphate control in over 90% of patients with a low pill burden [1][9] - The company ended Q2 2025 with $22.3 million in cash, providing a financial runway into the second half of 2026 [1][8] Business Update - The CEO of Unicycive highlighted progress in addressing deficiencies noted by the FDA related to a third-party manufacturing vendor, which was not linked to OLC [2] - The company remains committed to improving treatment options for managing hyperphosphatemia in dialysis patients, given the high rates of non-compliance with existing therapies [2] Financial Results - Research and Development (R&D) expenses for Q2 2025 were $1.8 million, a decrease from $4.9 million in Q2 2024, primarily due to reduced drug development costs [4] - General and Administrative (G&A) expenses increased to $5.2 million in Q2 2025 from $2.5 million in Q2 2024, mainly due to higher consulting and professional services for commercial launch preparation [5] - Other income for Q2 2025 was $0.5 million, a significant decrease from $17.3 million in Q2 2024, attributed to changes in the fair value of warrant liability [6] - The net loss attributable to common stockholders for Q2 2025 was $6.4 million, compared to a net income of $3.0 million in Q2 2024, primarily due to changes in warrant liability [7] Cash Position - As of June 30, 2025, Unicycive had cash and cash equivalents totaling $22.3 million, which is expected to fund operations into the second half of 2026 [8]