– FDA sets PDUFA Action Date of June 28, 2025 – Company Preparing for 2025 Commercial Launch – LOS ALTOS, Calif., Nov. 11, 2024 (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 the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for Oxylanthanum Carbonate (OLC) and has set a Prescription Drug User Fee Act (PDUFA) ...

– Late-Breaker Poster Presentation Highlights Favorable Safety & Tolerability of OLC – – Two Publications Recently Issued Featuring OLC and UNI-494 – LOS ALTOS, Calif., Oct. 28, 2024 (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 multiple presentations were delivered at the American Society of Nephrology (ASN) Kidney Week 2024 that highlighted t ...

LOS ALTOS, Calif., Oct. 14, 2024 (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 a poster presentation on oxylanthanum carbonate (OLC) was selected for a Late-Breaker session at the American Society of Nephrology (ASN) Kidney Week 2024. Unicycive will also deliver three additional poster presentations on OLC and UNI-494. The conference will take p ...

LOS ALTOS, Calif., Oct. 09, 2024 (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 the successful completion of the UNI-494 Phase 1 study in healthy volunteers. "We are pleased to announce the successful completion of the UNI-494 Phase 1 study that informs our next steps for advancement to a potential Phase 2 clinical trial in patients with acute kidney ...

LOS ALTOS, Calif., Sept. 16, 2024 (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 present a corporate update at the Virtual Life Sciences Investor Forum on Thursday, September 19, 2024 at 2:00 p.m. ET in New York, NY. A link to the live and archived webcast may be accessed on the Unicycive website ...

LOS ALTOS, Calif., Sept. 03, 2024 (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 the Company has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Oxylanthanum Carbonate (OLC) for the treatment of hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis. Unicycive is seeking FDA approval ...

Core Viewpoint - Unicycive Therapeutics, Inc. is set to present three poster presentations at the American Society of Nephrology Kidney Week 2024, showcasing their product candidates aimed at treating kidney disease [1][2]. Group 1: Product Candidates - The three presentations will cover the following topics: - **Intravenous UNI-494**: This candidate is reported to slow the progression or halt/reverse acute kidney injury when administered after ischemia/reperfusion in rats [3]. - **Combination of Oxylanthanum Carbonate and Tenapanor**: This combination is shown to lower urinary phosphate excretion in rats [3]. - **UNI-494 Phase I Study**: This study focuses on the safety, tolerability, and pharmacokinetics of UNI-494 [3]. Group 2: Oxylanthanum Carbonate (OLC) - OLC is a next-generation phosphate binding agent designed for treating hyperphosphatemia in chronic kidney disease patients, utilizing proprietary nanoparticle technology [4]. - The global market opportunity for treating hyperphosphatemia is projected to exceed $2.5 billion in 2023, with the U.S. accounting for over $1 billion [4]. - Despite existing FDA-cleared medications, 75% of U.S. dialysis patients do not achieve recommended phosphorus levels [4]. Group 3: Clinical Development - Unicycive is pursuing FDA approval for OLC through the 505(b)(2) regulatory pathway, having conducted two clinical studies involving over 100 healthy volunteers [5]. - A pivotal clinical trial in chronic kidney disease patients on hemodialysis demonstrated favorable tolerability of OLC at clinically effective doses [5]. Group 4: UNI-494 - UNI-494 is a novel nicotinamide ester derivative that acts as a selective ATP-sensitive mitochondrial potassium channel activator, potentially beneficial for treating acute kidney injury and chronic kidney disease [9]. - The Phase 1 dose-ranging safety study for UNI-494 has completed enrollment, with results expected in Q3 2024 [9]. Group 5: Acute Kidney Injury (AKI) - AKI is characterized by a sudden loss of kidney function, with primary causes including sepsis, ischemia, and drug-induced nephrotoxicity [10]. - It is estimated that 2 million people die from AKI globally each year, with survivors at increased risk for chronic kidney disease [10].

– On Track to Submit OLC New Drug Application (NDA) by End of August 2024 – LOS ALTOS, Calif., Aug. 14, 2024 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY) (the "Company" or "Unicycive"), a clinical-stage biotechnology company developing therapies for patients with kidney disease, today announced its financial results for the three months ended June 30, 2024, and provided a business update. "Achieving successful results from our oxylanthanum carbonate (OLC) pivotal trial was a significant m ...

"We are pleased to receive this patent from the USPTO, which ensures intellectual property protection for many years to come," said Shalabh Gupta, MD, Chief Executive Officer of Unicycive. "This Method of Use patent for UNI-494 is an important component of our strategy to become a leader in the development of drugs that target kidney disease. UNI-494 is currently in an ongoing Phase 1 clinical trial and recently received Orphan Drug Designation in Delayed Graft Function, a form of acute kidney injury. This ...

Patent and Intellectual Property - Unicycive Therapeutics received U S Patent No 12 036 211 for UNI-494, a compound targeting acute kidney injury and contrast-induced nephropathy, with protection valid until 2040 [1][2] - The patent covers a method of treating kidney-related conditions using UNI-494, without limitations on salt, dose, or administration type [2] - UNI-494 is a novel nicotinamide ester derivative and a selective ATP-sensitive mitochondrial potassium channel activator, addressing mitochondrial dysfunction in kidney diseases [2][4] Clinical Development and Strategy - UNI-494 is currently in a Phase 1 clinical trial in the UK, expected to complete in the second half of 2024 [4] - The compound has received Orphan Drug Designation from the FDA for Delayed Graft Function, a type of acute kidney injury [3][4] - The patent strengthens the company's strategy to lead in kidney disease drug development and expands its intellectual property portfolio [3] Market and Disease Context - Acute kidney injury (AKI) affects 20-200 per million population in the community, 7-18% of hospitalized patients, and approximately 50% of ICU patients [5] - AKI is associated with high morbidity and mortality, with an estimated 2 million deaths annually worldwide [5] - Delayed Graft Function, a form of AKI, occurs in the first week after kidney transplantation and is a key focus for UNI-494 [5] Company Overview - Unicycive Therapeutics is a biotechnology company focused on developing novel treatments for kidney diseases [6] - The company's lead drug candidate, oxylanthanum carbonate (OLC), targets hyperphosphatemia in chronic kidney disease patients on dialysis [6] - UNI-494 is a patent-protected new chemical entity in clinical development for acute kidney injury-related conditions [6]