Unicycive Therapeutics, Inc.
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- Unicycive Therapeutics, Inc. (NASDAQ: UNCY) is a clinical-stage biotechnology company focused on developing novel therapies for kidney diseases, including hyperphosphatemia in chronic kidney disease (CKD) patients on dialysis and acute kidney injury (AKI). The company's lead investigational treatment, oxylanthanum carbonate (OLC), is a next-generation lanthanum-based phosphate binding agent utilizing proprietary nanoparticle technology that reduces pill burden through smaller, swallowable pills versus chewed alternatives; OLC has received a Prescription Drug User Fee Act (PDUFA) target action date of June 28, 2025 from the U.S. Food and Drug Administration (FDA), following a Complete Response Letter (CRL) on June 30, 2025, with plans to resubmit the New Drug Application (NDA) by year-end 2025. Its second pipeline candidate, UNI-494, is a novel nicotinamide ester derivative and selective ATP-sensitive mitochondrial potassium channel activator designed to restore mitochondrial function for AKI treatment, potentially addressing an unmet need with no approved therapies currently available. Unicycive Therapeutics maintains license and development agreements with partners including Shilpa Medicare Ltd. for manufacturing and supply of OLC, Sphaera Pharma Pte. Ltd. for UNI-494, Lee's Pharmaceutical (HK) Limited and Lotus International Pte Ltd. for OLC commercialization in select Asian markets such as Mainland China and Hong Kong, and Syneos Health LLC for UNI-494 development support. Recent strategic developments include a $50 million private placement financing in March 2024 led by Octagon Capital and Great Point Partners to advance OLC toward approval and commercialization, a 1:10 reverse stock split effective June 20, 2025 to regain Nasdaq compliance confirmed on July 7, 2025, and RA Capital Management's acquisition of approximately 10 million shares representing a 9.99% stake as of September 30, 2024. The company reported $42.7 million in cash as of September 30, 2025, providing runway into 2027 to support OLC resubmission, potential approval, commercialization preparations, and UNI-494 advancement. Founded in 2016 and headquartered in Los Altos, California, Unicycive Therapeutics targets patients with CKD and AKI primarily in the United States, with strategic partnerships expanding potential access in Asia.
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Kuehn Law Encourages Investors of Unicycive Therapeutics, Inc. to Contact Law Firm
Unicycive Therapeutics to Present at the 25th Annual Needham Virtual Healthcare Conference
Unicycive Therapeutics Announces Full Year 2025 Financial Results and Provides Business Update
Unicycive Therapeutics, Inc. (NASDAQ:UNCY) Receives Consensus Rating of “Moderate Buy” from Analysts
Kuehn Law Encourages Investors of Unicycive Therapeutics, Inc. to Contact Law Firm
Important Notice to Long-Term Shareholders of Unicycive Therapeutics, Inc. (UNCY): Grabar Law Office Is Investigating Claims on Your Behalf
Unicycive Therapeutics to Participate in a Fireside Chat at Guggenheim's Emerging Outlook: Biotech Summit
Unicycive: 'Buy' Rating On NDA Resubmission OLC And Potential Best-In-Class Profile
UPDATE - Unicycive Therapeutics Announces FDA Acceptance of Oxylanthanum Carbonate (OLC) New Drug Application (NDA) Resubmission
Unicycive Therapeutics Announces FDA Acceptance of Oxylanthanum Carbonate (OLC) New Drug Application (NDA) Resubmission
Unicycive Therapeutics Announces Resubmission of New Drug Application (NDA) for Oxylanthanum Carbonate (OLC)
Important Notice to Long-term Shareholders of Unicycive Therapeutics, Inc. (UNCY): Grabar Law Office Is Investigating Claims on Your Behalf
Unicycive Therapeutics to Participate in Upcoming Investor Events in December
Bragar Eagel & Squire is Investigating Certain Officers and Directors of Quantum, Unicycive, Fly-E, and Lantheus on Behalf of Long-Term Stockholders and Encourages Investors to Contact the Firm
Unicycive Therapeutics Announces Third Quarter 2025 Financial Results and Provides Business Update
Unicycive Therapeutics to Participate in a Fireside Chat at the Guggenheim 2nd Annual Healthcare Innovation Conference
UNICYCIVE ALERT: Bragar Eagel & Squire, P.C. is Investigating Unicycive Therapeutics, Inc. on Behalf of Long-Term Stockholders and Encourages Investors to Contact the Firm