Welcome to our dedicated page for Unicycive Therapeutics news (Ticker: UNCY), a resource for investors and traders seeking the latest updates and insights on Unicycive Therapeutics stock.
Unicycive Therapeutics, Inc. (UNCY) is a clinical-stage biotechnology company whose news flow centers on the development and regulatory progress of kidney disease therapies. Company press releases highlight advances for its lead investigational product oxylanthanum carbonate (OLC), an oral phosphate binder for hyperphosphatemia in chronic kidney disease patients on dialysis, and for its second program UNI-494, which is intended for conditions related to acute kidney injury.
Investors following UNCY news can expect detailed updates on regulatory interactions with the U.S. Food and Drug Administration, including New Drug Application submissions, Complete Response Letters, Type A meetings, and NDA resubmissions for OLC. The company also reports on pivotal and Phase 2 clinical trial results, analyses of pill burden and phosphate control, and publications of OLC data in peer-reviewed journals such as the Clinical Journal of the American Society of Nephrology.
Unicycive’s news releases frequently cover financial results, cash runway commentary, and capital markets activities, such as at-the-market equity offerings and reverse stock split implementation, as disclosed in associated Form 8-K filings. Additional news items include participation in healthcare and investor conferences, issuance of new patents for UNI-494 and its use in chronic kidney disease, and corporate updates on Nasdaq listing compliance and legal matters, including disclosure of a purported securities class action.
This UNCY news page aggregates these company-issued updates so readers can review clinical data milestones, regulatory developments, intellectual property announcements, and financial disclosures in one place. For those tracking the progress of oxylanthanum carbonate and UNI-494, the news feed provides a chronological view of Unicycive’s communications about its kidney disease pipeline and corporate activities.
Unicycive Therapeutics announced positive initial patient satisfaction results from its pivotal clinical trial for oxylanthanum carbonate (OLC) in patients with hyperphosphatemia who have chronic kidney disease on dialysis. The survey, part of the UNI-OLC-201 trial, revealed that 79% of patients preferred OLC over their previous phosphate binders, with 98% finding it easy to take compared to 55% for their prior medication. Additionally, 89% of patients reported satisfaction with OLC versus 49% for their previous therapy. The median daily pill burden was halved when switching to OLC. These findings support the potential best-in-class profile of OLC, and the company plans to file a New Drug Application soon.
Unicycive Therapeutics (Nasdaq: UNCY), a clinical-stage biotechnology company, announced its inclusion in the Russell Microcap Index, effective July 1, 2024. This follows the annual reconstitution of the Russell US Indexes, which ranks the 4,000 largest US stocks by market capitalization. Membership in the index lasts for one year and includes automatic inclusion in relevant growth and value style indexes. The company believes this milestone will boost its visibility among investors, furthering momentum gained from recent positive clinical trial results for oxylanthanum carbonate (OLC).
Unicycive Therapeutics announced positive results from its pivotal clinical trial for Oxylanthanum Carbonate (OLC), a phosphate binding agent for chronic kidney disease (CKD) patients. The trial demonstrated promising tolerability and safety, with only 6% of patients discontinuing due to adverse events (AEs), significantly lower than the 14% discontinuation rate for Fosrenol. Only 1.4% of evaluable patients discontinued due to treatment-related AEs. Most AEs were mild to moderate, with no serious adverse events reported. Additionally, 90% of patients achieved target phosphate levels after titration, supporting OLC's potential as a best-in-class treatment. The company plans to submit a New Drug Application (NDA) to the FDA in Q3 2024.
Unicycive Therapeutics presented data on its two product candidates, oxylanthanum carbonate (OLC) and UNI-494, at the European Renal Association Congress on May 28, 2024. OLC demonstrated a three-fold greater phosphate lowering capacity compared to tenapanor in a preclinical model of CKD, showing its potential as a treatment for hyperphosphatemia. UNI-494, an ATP-sensitive mitochondrial potassium channel activator, showed significant reduction in important markers for acute kidney injury (AKI) in a preclinical model, indicating its potential for preventing delayed graft function (DGF). Additionally, ongoing clinical trials for both products were highlighted with results expected later in the year.
Unicycive Therapeutics (Nasdaq: UNCY), a clinical-stage biotechnology company focusing on therapies for kidney disease, announced its participation in a Fireside Chat at the Lytham Partners Spring 2024 Investor Conference.
Dr. Shalabh Gupta, CEO, will represent Unicycive at the virtual event on May 30, 2024, at 9:30 a.m. ET. The live and archived webcast will be accessible on the Unicycive website under the Investors section for three months.
Unicycive Therapeutics presented two posters on their lead product, oxylanthanum carbonate (OLC), at the National Kidney Foundation Spring Clinical Meeting. The key points include:
1. OLC shows bioequivalence to lanthanum carbonate, with similar outcomes in mean change in urinary phosphate excretion and no serious adverse events.
2. The study was a Phase 1, randomized, crossover bioequivalence study involving healthy volunteers.
3. A survey of renal dietitians highlighted non-compliance with phosphate binders as a major issue, with OLC's smaller, swallowable tablets potentially improving patient adherence.
4. Findings support OLC as a candidate for a New Drug Application filing with the FDA under the 505(b)(2) regulatory pathway.
Unicycive Therapeutics (Nasdaq: UNCY) reported its Q1 2024 financial results and provided a business update.
The pivotal clinical trial for its lead asset, oxylanthanum carbonate (OLC), is on track with topline data expected in Q2 2024. Additionally, OLC and UNI-494 will be featured in multiple presentations at upcoming nephrology conferences. The company has completed enrollment in the pivotal OLC trial. UNI-494, aimed at preventing delayed graft function in kidney transplant patients, has progressed through the multiple ascending dose portion of Phase 1 trials with results expected later this year.
Unicycive was granted orphan drug designation for UNI-494 by the FDA, providing potential benefits such as tax credits and market exclusivity. The company completed a $50 million private placement, bolstering its cash position to $48.9 million as of March 31, 2024. However, the company reported a net loss of $21.2 million for Q1 2024, primarily due to increased R&D and administrative expenses.
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