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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, Inc. (Nasdaq: UNCY) will present new data on the bioequivalence study for its lead product candidate, oxylanthanum carbonate (OLC), at the National Kidney Foundation Spring Clinical Meeting. The Company aims to address patient non-compliance issues with phosphate binders through survey results, contributing to the healthcare community's knowledge on kidney disease.
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Unicycive Therapeutics, Inc. (UNCY) announced new preclinical data on UNI-494, a clinical-stage biotechnology company developing therapies for patients with kidney disease. The data will be presented at the 29th International Conference on Advances in Critical Care Nephrology AKI and CRRT 2024 in San Diego, CA, showcasing the efficacy of UNI-494 in animal models of delayed graft function and describing the ongoing Phase 1 clinical trial design for UNI-494 in healthy volunteers. The company's primary focus remains on advancing its lead drug, OLC, towards a New Drug Application submission.
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Unicycive Therapeutics, Inc. (UNCY) issues a letter to shareholders, highlighting the progress made in its clinical programs, especially with the lead program OLC, a next-generation lanthanum-based phosphate binding agent. The company expects to report topline data from the pivotal clinical trial for OLC in Q2 2024, targeting the multibillion-dollar hyperphosphatemia market. Additionally, the company continues to advance its second compound UNI-494 for the treatment of acute kidney injury and chronic kidney disease.
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Unicycive Therapeutics, Inc. (Nasdaq: UNCY) has announced the enrollment of the first patient in its OLC pivotal clinical trial for the treatment of hyperphosphatemia in patients with chronic kidney disease on dialysis. The trial is expected to enroll 60 participants with results anticipated in Q2 2024. OLC is a next-generation lanthanum-based phosphate binding agent with the potential to become the best-in-class phosphate binder in the hyperphosphatemia market. The primary endpoint of the study will evaluate the tolerability of clinically effective doses of OLC, with secondary endpoints focusing on safety and pharmacokinetics. The company aims to file a New Drug Application (NDA) shortly after reporting data from the trial.
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Unicycive Therapeutics, Inc. (Nasdaq: UNCY) announced that its CEO will participate in two investor conferences in December 2023, presenting at the Noble Capital Markets 19th Annual Emerging Growth Equity Conference on December 4, 2023, and the 2023 Benchmark Discovery One-on-One Investor Conference on December 7, 2023.
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Unicycive Therapeutics, Inc. (Nasdaq: UNCY) reached alignment with the FDA on data package requirements to file NDA for oxylanthanum carbonate (OLC). The pivotal clinical trial for OLC is expected to start before the year-end, with topline data anticipated in mid-2024. Dr. Sara Kenkare-Mitra joined the Board of Directors, and the company reported positive results on OLC's phosphate binding capacity. Financially, licensing revenues were $0, R&D expenses decreased, G&A expenses increased, and the net loss attributable to common stockholders decreased to $4.4 million.
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Unicycive Therapeutics has reached alignment with the FDA on the path forward for Oxylanthanum Carbonate (OLC) and the overall package requirements to file a New Drug Application. The company plans to initiate a pivotal clinical trial for OLC before the end of the year, with top line data expected in the second quarter of 2024. As of June 30, 2023, Unicycive's cash position was reported as $18.8 million, expected to last into the second half of 2024.
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Unicycive Therapeutics appoints Sara Kenkare-Mitra, PhD to Board of Directors
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Unicycive Therapeutics CEO featured on Nasdaq Amplify Issuer Spotlight interview series
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Unicycive Therapeutics, Inc. announced its financial results for Q2 2023. The company highlighted the benefits of Oxylanthanum Carbonate (OLC) in improving medication adherence and quality of life for patients with chronic kidney disease. They expect feedback from the FDA in Fall 2023 for the OLC program. The UNI-494 Phase 1 trial is progressing as planned, with an IND application expected in 2024. Recent data publications demonstrated the potential of OLC and UNI-494, reinforcing the company's commitment to bringing new treatment options to patients.
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FAQ

What is the current stock price of Unicycive Therapeutics (UNCY)?

The current stock price of Unicycive Therapeutics (UNCY) is $0.684 as of December 20, 2024.

What is the market cap of Unicycive Therapeutics (UNCY)?

The market cap of Unicycive Therapeutics (UNCY) is approximately 75.8M.

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

UNCY Rankings

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75.75M
97.44M
6.73%
38.24%
1.12%
Biotechnology
Pharmaceutical Preparations
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United States of America
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