Business
Unicycive Announces Third Quarter Financial Results and Provides Business Update
Topline results by year-end as enrollment completed for pivotal bioequivalence study of RENAZORB™ (lanthanum dioxycarbonate), an investigational phosphate
About this update from Unicycive Therapeutics, Inc.
[{"type":"text","content":"Topline results by year-end as enrollment completed for pivotal bioequivalence study of RENAZORB™ (lanthanum dioxycarbonate), an investigational phosphate binder for the treatment of hyperphosphatemia in Chronic Kidney Disease (CKD) patients on dialysis On track to file New Drug Application for RENAZORB in 2023 Expect clearance for a Phase 1 healthy volunteer study of UNI-494, a novel proprietary drug targeting the SUR2B subunit of the mitochondrial KATP channel, in the UK by year-end LOS ALTOS, Calif., Nov. 14, 2022 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease, today announced its financial results for the third quarter ended September 30, 2022, and provided a business update. Management Commentary “The third quarter of 2022 and recent weeks have been particularly productive as we completed enrollment of our pivotal bioequivalence trial of RENAZORB, with topline results expected by year-end. We remain on track to file a New Drug Application (NDA) in 2023,” said Shalabh Gupta, M.D., Chief Executive Officer of Unicycive. “In addition to signing our first global partnership for the marketing and commercialization of RENAZORB in China with Lee’s Pharmaceutical, we continue to make strides in advancing discussions for additional potential partnerships across Asia and Europe in order to bring the benefits of this exciting new medicine to hyperphosphatemia patients around the globe.” Dr. Gupta added, “We were delighted to share favorable results from both our product candidates with the nephrology community at this year’s Kidney Week. The data we presented on RENAZORB demonstrated its ability to effectively reduce urinary phosphate excretion and underscored the daily pill burden of various phosphate binder therapies, further supporting RENAZORB’s potential best-in-class product profile. In addition, preclinical data on the pharmacokinetics of UNI-494 support its ability to reduce oxidative stress and restore mitochondrial function in several potential indications.” “We continue to execute our strategy and remain excited about the opportunities ahead for Unicycive as we advance our clinical studies and expand access to RENAZORB globally. Additionally, we continue to elucidate UNI-494’s novel mechanism to improve mitochondria...