Unicycive Therapeutics Inc Stock Price, News & Analysis

Unicycive Therapeutics (Nasdaq: UNCY) announced the acceptance of four abstracts for presentation at the World Congress of Nephrology 2023 in Bangkok from March 30 – April 2. Key presentations will include data on Renazorb's phosphate binding capabilities from a Phase 1 clinical study and preclinical assessments of UNI-494. The company is optimistic about filing a New Drug Application for Renazorb with the FDA mid-2023, which could enhance its market position and partnership opportunities.

Unicycive Therapeutics, Inc. (Nasdaq: UNCY) has announced the termination of its "at-the-market" equity offering program to mitigate shareholder dilution. The termination process begins immediately and will be finalized on January 8, 2023. The company has not conducted any sales under this offering since December 15, 2022. Unicycive is focused on developing therapies for kidney disease, including its lead drug, Renazorb, for hyperphosphatemia and UNI-494 for acute kidney injury. Additional details are available in the company's recent SEC filing.

Unicycive Therapeutics announced successful results from a pivotal bioequivalence study of Renazorb compared to Fosrenol, meeting the primary endpoint and establishing pharmacodynamic bioequivalence. This finding supports the upcoming New Drug Application submission scheduled for mid-2023. Renazorb, designed to treat hyperphosphatemia in chronic kidney disease patients, aims to reduce the pill burden, potentially improving patient compliance. The global market for hyperphosphatemia treatment exceeds $2.5 billion, with significant unmet needs in patient management.

Unicycive Therapeutics has received acceptance from the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) for its UNI-494 Phase 1 study, targeting patients with acute kidney injury. This first-in-human trial is set to begin in Q1 2023, following successful completion of preclinical safety assessments. UNI-494, which activates mitochondrial K_ATP channels, is supported by extensive safety data from earlier studies on its active metabolite, nicorandil. The company also plans to file an Investigational New Drug application with the FDA for a Phase 2 trial in 2023.

Unicycive Therapeutics, Inc. (NASDAQ:UNCY) will be featured in an interview on The RedChip Money Report® airing on Bloomberg TV on December 10, 2022, at 7 p.m. ET. CEO Shalabh Gupta will discuss key developments, including data from the upcoming bioequivalence study and the forthcoming Phase 1 trial for the company’s lead program targeting hyperphosphatemia. The interview aims to highlight Unicycive's innovative approaches in treating significant kidney diseases with unmet medical needs.

Unicycive Therapeutics (Nasdaq: UNCY) announced participation in two key conferences to highlight their innovative therapies. The Sequire Technology Conference will feature a company presentation on November 30, 2022, at 11:30 a.m. ET. Additionally, Unicycive will engage in 1x1 meetings at Benchmark’s 11th Annual Discovery Conference on December 1, 2022, at the New York Athletic Club. The company is developing Renazorb for hyperphosphatemia and UNI-494 for mitochondrial dysfunction, targeting unmet medical needs in kidney diseases.

Unicycive Therapeutics (Nasdaq: UNCY) announced third-quarter 2022 financial results and significant business updates. The company has completed enrollment for its pivotal bioequivalence study of RENAZORB, an investigational phosphate binder for hyperphosphatemia in CKD patients, with topline results expected by year-end. They plan to file a New Drug Application (NDA) in 2023. Unicycive has also signed a global partnership for RENAZORB’s commercialization in China, receiving $1 million upfront. Research and development expenses increased to $4.8 million, resulting in a net loss of $5.6 million for the quarter.

Unicycive Therapeutics, Inc. (Nasdaq: UNCY) has completed subject enrollment in the RENAZORB bioequivalence study, aimed at treating hyperphosphatemia in chronic kidney disease patients on dialysis. The randomized BE study, approved by the FDA, involves 80 subjects and measures urinary phosphate excretion changes. Topline data is expected by year-end 2022, with plans to file a New Drug Application (NDA) in 2023. RENAZORB's unique nanoparticle technology may enhance patient adherence compared to existing treatments. The company anticipates significant market opportunities for this advanced phosphate binder.

Unicycive Therapeutics (Nasdaq: UNCY) is set to showcase its kidney disease therapies at the ASN Kidney Week 2022, scheduled for Nov 3-6, in Orlando, Florida. CEO Shalabh Gupta highlighted the serious issue of hyperphosphatemia in end-stage renal patients and discussed the potential of Renazorb, an advanced phosphate binder, and UNI-494, a candidate for acute kidney injury treatment. Clinical trials for Renazorb have demonstrated its safety and efficacy, significantly reducing phosphate excretion. The company aims to transform treatment for kidney disorders, addressing major compliance challenges.