LOS ALTOS, Calif., July 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 Shalabh Gupta, M.D., Chief Executive Officer will participate in a Fireside Chat at the H.C. Wainwright 3rd Annual Kidney Virtual Conference on Monday, July 15, 2024 at 2:00 p.m. ET. About Unicycive Therapeutics Investor Contact: SOURCE: Unicycive Therapeutics, Inc. A ...

Unicycive Therapeutics is a biotechnology company developing novel treatments for kidney diseases. Unicycive's lead drug candidate, oxylanthanum carbonate (OLC), is a novel investigational phosphate binding agent being developed for the treatment of hyperphosphatemia in chronic kidney disease patients on dialysis. UNI-494 is a patent-protected new chemical entity in clinical development for the treatment of conditions related to acute kidney injury. For more information, please visit Unicycive.com and follo ...

– Patients preferred OLC more than 4 to 1 over their prior phosphate binder therapy – LOS ALTOS, Calif., July 10, 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 initial results from the patient reported outcome survey conducted during the UNI-OLC-201 pivotal clinical trial. The positive top-line results from the oxylanthanum carbonate (OLC) t ...

LOS ALTOS, Calif., July 10, 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 initial results from the patient reported outcome survey conducted during the UNI-OLC-201 pivotal clinical trial. The positive top-line results from the oxylanthanum carbonate (OLC) trial in patients with hyperphosphatemia who have chronic kidney disease on dialysis we ...

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Core Insights - Unicycive Therapeutics announced positive results from the pivotal clinical trial of Oxylanthanum Carbonate (OLC), demonstrating favorable tolerability and safety for patients with chronic kidney disease (CKD) [1][2][6] - The company anticipates submitting a New Drug Application (NDA) for OLC in Q3 2024, utilizing the 505(b)(2) regulatory pathway [1][6][24] Summary by Categories Clinical Trial Results - The UNI-OLC-201 trial showed a low discontinuation rate due to adverse events (AEs), with only 6% (5 out of 86 patients) discontinuing, which is significantly lower than the 14% rate for Fosrenol® [2][3] - In the Evaluable Population (n=71), only 1 patient discontinued due to a treatment-related AE, resulting in a rate of 1.4% [3][13] - The full Safety Population (n=86) had a total of 3 treatment-related discontinuations, yielding a rate of 3.5% [3][13] Safety and Tolerability - Most treatment-related AEs were mild to moderate, with no serious adverse events reported [4][13] - The most common AEs were diarrhea (9%) and vomiting (6%), which are comparable to other phosphate binders [4][13] Efficacy Insights - Although the study was not designed to evaluate efficacy, 90% of patients achieved phosphate levels ≤5.5 mg/dL after titration with OLC [5][15] - At baseline, 59% of patients had phosphate levels ≤5.5 mg/dL, and after washout from prior phosphate binders, 90% achieved the target level [5][15] Market Potential - The global market for treating hyperphosphatemia is projected to exceed $2.5 billion in 2023, with the U.S. accounting for over $1 billion [17] - Approximately 40% of dialysis patients struggle to achieve adequate serum phosphate control, highlighting a significant unmet need in the market [6][17] Company Overview - Unicycive Therapeutics is focused on developing novel treatments for kidney diseases, with OLC being a next-generation phosphate binding agent utilizing proprietary nanoparticle technology [1][20][17] - The company has over forty issued and granted patents globally for OLC, which aims to improve patient adherence by reducing the pill burden compared to existing treatments [17][20]

– Results from Preclinical Model of Hyperphosphatemia Demonstrate the Relative Potency of OLC Compared to Tenapanor – – Oral UNI-494 Shows Promise in a Preclinical Model as a Potential Candidate for Prevention of Delayed Graft Function Related to Acute Kidney Injury – LOS ALTOS, Calif., May 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 ...

– Results from Preclinical Model of Hyperphosphatemia Demonstrate the Relative Potency of OLC Compared to Tenapanor – – Oral UNI-494 Shows Promise in a Preclinical Model as a Potential Candidate for Prevention of Delayed Graft Function Related to Acute Kidney Injury – LOS ALTOS, Calif., May 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 ...

– On Track to Provide Topline Data from the Ongoing Pivotal Clinical Trial with Oxylanthanum Carbonate (OLC) in Q2 2024 – Exhibit 99.1 Unicycive Announces First Quarter 2024 Financial Results and Provides Business Update – Multiple Presentations on OLC and UNI-494 at Prominent, Upcoming Medical Meetings – LOS ALTOS, Calif., May 13, 2024 – Unicycive Therapeutics, Inc. (Nasdaq: UNCY) (the "Company" or "Unicycive"), a clinical- stage biotechnology company developing therapies for patients with kidney disease, ...