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Unicycive Therapeutics, Inc. - UNCY STOCK NEWS

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. (NASDAQ: UNCY) is a biotechnology company committed to developing innovative treatments for kidney diseases with significant unmet medical needs. The company's primary focus lies in addressing hyperphosphatemia and acute kidney injury (AKI) through its advanced drug candidates: Renazorb and UNI-494.

Renazorb is a novel phosphate-binding agent under development for the treatment of hyperphosphatemia. Utilizing proprietary nanoparticle technology, Renazorb aims to reduce the pill burden for patients, thereby promising better adherence and compliance. Hyperphosphatemia, a common condition in patients with End Stage Renal Disease (ESRD), if left untreated, can lead to severe complications such as secondary hyperparathyroidism, renal osteodystrophy, and cardiovascular diseases. Despite the availability of several FDA-approved treatments, around 75% of U.S. dialysis patients fail to achieve target phosphorus levels. Renazorb has the potential to capture a significant share of the market, which exceeds $2.5 billion globally.

UNI-494 is another promising candidate, a novel nicotinamide ester derivative designed for the treatment of AKI. UNI-494 works by restoring mitochondrial function, a critical factor in kidney health. The drug is currently in Phase 1 dose-ranging safety studies in the United Kingdom, with completion expected in the second half of 2024. UNI-494 has been granted orphan drug designation by the U.S. FDA for the prevention of Delayed Graft Function (DGF) in kidney transplant patients. DGF is a serious complication following kidney transplantation, often requiring dialysis intervention during the first week post-transplant.

Unicycive recently received significant financial backing from leading healthcare investors, including Octagon Capital and Great Point Partners, LLC., in addition to support from existing investors like Logos Capital and Nantahala Capital. This funding will likely support the company's ongoing research and development efforts.

For the latest updates, Unicycive expects topline data from its clinical studies by the second quarter of 2024. This progress underscores Unicycive's commitment to delivering groundbreaking treatments for kidney disease patients worldwide.

For investor inquiries, please contact: ir@unicycive.com or call (650) 543-5470.

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Unicycive Therapeutics (Nasdaq: UNCY) has been granted U.S. Patent No. 12,036,211 by the USPTO for UNI-494, ensuring intellectual property protection until 2040. The patent covers a method of treating acute kidney injury or contrast-induced nephropathy using the UNI-494 compound, a novel nicotinamide ester derivative and selective ATP-sensitive mitochondrial potassium channel activator.

UNI-494 is currently in a Phase 1 clinical trial and has received Orphan Drug Designation for Delayed Graft Function, a form of acute kidney injury. This patent is a important component of Unicycive's strategy to become a leader in developing drugs targeting kidney disease.

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Unicycive Therapeutics (Nasdaq: UNCY), a clinical-stage biotech company focused on kidney disease therapies, announced participation in the H.C. Wainwright 3rd Annual Kidney Virtual Conference. CEO Shalabh Gupta, M.D. will engage in a Fireside Chat on July 15, 2024, at 2:00 p.m. ET. The event will be accessible live and as an archived webcast for three months on Unicycive's website under the Investors section: Events and Presentations.

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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.

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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).

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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.

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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.

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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.

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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.

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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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Unicycive Therapeutics, Inc. (UNCY) will have its CEO present a company update at a healthcare conference. The webcast will be available for three months on the Unicycive website.
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FAQ

What is Unicycive Therapeutics, Inc.?

Unicycive Therapeutics, Inc. is a biotechnology company focused on developing treatments for kidney diseases with significant unmet medical needs.

What is Renazorb?

Renazorb is a novel phosphate-binding agent being developed by Unicycive for the treatment of hyperphosphatemia.

What is UNI-494?

UNI-494 is a new chemical entity with a novel mechanism of action aimed at treating acute kidney injury. It is currently in Phase 1 clinical trials.

What are hyperphosphatemia and its complications?

Hyperphosphatemia is a condition of elevated phosphate levels in the blood, common in ESRD patients. It can lead to complications like secondary hyperparathyroidism, renal osteodystrophy, and cardiovascular diseases.

What is Delayed Graft Function (DGF)?

DGF is an acute kidney injury occurring within the first week post-kidney transplantation, often requiring dialysis. It can lead to impaired graft function and higher rates of tissue rejection.

What is the market opportunity for Renazorb?

The global market opportunity for treating hyperphosphatemia is projected to exceed $2.5 billion in 2023, with the U.S. accounting for over $1 billion.

Who are the major investors in Unicycive?

Leading investors include Octagon Capital, Great Point Partners, LLC, Logos Capital, and Nantahala Capital.

When will the topline data be available?

Topline data from Unicycive's clinical studies are expected in the second quarter of 2024.

How can I contact Unicycive for investor inquiries?

You can contact Unicycive at ir@unicycive.com or call (650) 543-5470 for investor inquiries.

What is the significance of UNI-494's orphan drug designation?

The orphan drug designation by the U.S. FDA allows UNI-494 to receive benefits like market exclusivity, grants, and tax credits for its development aimed at treating rare conditions like Delayed Graft Function.

Unicycive Therapeutics, Inc.

Nasdaq:UNCY

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Research and Development in Biotechnology
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