Business
Unicycive Announces Second Quarter Financial Results and Provides Business Update
On track to file New Drug Application for Renazorb, the first proprietary nanoparticle-based phosphate binder for Chronic Kidney Disease (CKD) patients, by
About this update from Unicycive Therapeutics, Inc.
[{"type":"text","content":"On track to file New Drug Application for Renazorb, the first proprietary nanoparticle-based phosphate binder for Chronic Kidney Disease (CKD) patients, by end of 2023 Signed first global partnership for rights to Renazorb in China with Lee’s Pharmaceutical (HK) Ltd. to further advance global commercial strategy for product with a differentiated profile and ease of administration for CKD patients Expects to file regulatory submission to initiate a Phase 1 healthy volunteer study in 2H’22 with UNI-494, a novel proprietary drug targeting the SUR2 subunit of the mitochondrial KATP channel activator LOS ALTOS, Calif., Aug. 15, 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 second quarter ended June 30, 2022 and provided a business update. Management Commentary “We made considerable progress executing our strategy throughout the first half of the year. Toward that end, we were delighted to initiate our pivotal bioequivalence trial of Renazorb®, which keeps us on track to complete the study around year end and to file a New Drug Application (NDA) in 2023. In addition, we signed our first global partnership for the marketing and commercialization of Renazorb in China with Lee’s Pharmaceutical (HK) Limited (HKEX: 0950). This agreement provides Unicycive with non-dilutive funding, including a $1.0 million upfront payment received in August, which underscores the potential for Renazorb as a best-in-class phosphate binder worldwide.” “We continue to develop and build compelling scientific knowledge in support of UNI-494’s unique mechanism of action to restore mitochondrial function in a variety of diseases that are affected by mitochondrial dysfunction and look forward to regulatory filing to initiate the first-in-humans clinical program for UNI-494 in the second half of the year,” said Shalabh Gupta, M.D., Chief Executive Officer. “We are adequately funded into 2023, which is expected to allow us to advance Renazorb to NDA filing and to initiate the clinical trial for UNI-494. We continue to execute according to our plan and remain excited about the opportunities ahead for Unicycive as we advance our clinical studies, expand access to Renazorb around the world and further elucid...