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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.
Unicycive Therapeutics (Nasdaq: UNCY) announced a Key Opinion Leader (KOL) Event featuring Dr. Glenn Chertow from Stanford University on April 20, 2022. The event, titled “Novel Treatments in Kidney Disease,” aims to discuss innovative therapies for kidney disease, particularly hyperphosphatemia affecting over 500,000 chronic kidney disease patients in the U.S. Unicycive is developing Renazorb, a phosphate binder, and a pro-drug of nicorandil for treating both acute and chronic kidney conditions. The live webcast will be available for 90 days post-event.
Unicycive Therapeutics (Nasdaq: UNCY) reported its financial results for 2021, highlighting significant progress in clinical development. The FDA confirmed a regulatory pathway for its lead product, Renazorb, aimed at treating hyperphosphatemia in chronic kidney disease patients. The company plans to initiate a clinical bioequivalence study in healthy volunteers in Q2 2022. R&D expenses rose to $6.1 million from $1.0 million in 2020, while the net loss increased to $10.0 million, or $0.86 per share. Cash and equivalents stood at $16.6 million as of December 31, 2021.
Unicycive Therapeutics will celebrate National Kidney Month by ringing the Nasdaq Closing Bell on March 29, 2022, at 4:00 PM ET. The event, featuring CEO Shalabh Gupta, highlights the unmet medical needs for kidney disease treatments. Unicycive is progressing towards regulatory approval for its lead drug, Renazorb, aimed at treating hyperphosphatemia, and plans to file for UNI-494 targeting acute kidney injury later in the year. The Nasdaq listing has enhanced liquidity and visibility among institutional investors.
Unicycive Therapeutics (Nasdaq: UNCY) has announced that Dr. Shalabh Gupta, CEO, will present at two investor conferences in March 2022. The first is the 34th Annual ROTH Conference from March 13-15, where Dr. Gupta will offer an online presentation and participate in one-on-one meetings. The second event is the Maxim Group 2nd Annual Virtual Growth Conference on March 28 at 1:00 pm Eastern Time, featuring a fireside chat format. Unicycive is focused on developing innovative therapies for kidney diseases, including its lead drug Renazorb.
Unicycive Therapeutics (Nasdaq: UNCY) announced that two abstracts highlighting the efficacy and safety of Renazorb (lanthanum dioxycarbonate) will be presented at the National Kidney Foundation (NKF) Spring Clinical Meeting from April 6-10, 2022, in Boston. Renazorb aims to treat hyperphosphatemia in chronic kidney disease patients, utilizing advanced nanoparticle technology for better phosphate binding. The data presented will support Renazorb's potential as a leading phosphate binder with fewer dosage pills required.
Unicycive Therapeutics, a clinical stage biotechnology company focused on kidney disease therapies, announced that CEO Shalabh Gupta will present at the H.C. Wainwright BIOCONNECT Virtual Conference from January 10-13, 2022. The presentation can be accessed on the company's website under the Investors section starting January 10, 2022, at 7:00 a.m. ET. Unicycive is developing innovative treatments, including Renazorb, a phosphate binding agent for hyperphosphatemia, and UNI-494, a new chemical entity in late preclinical development for acute kidney injury.
Unicycive Therapeutics (Nasdaq: UNCY) announced progress on Renazorb, a second-generation phosphate binding agent for hyperphosphatemia in chronic kidney disease patients. Following a Type C interaction, the FDA confirmed the drug's comparability to Fosrenol and endorsed the 505(b)(2) NDA submission pathway based on a clinical bioequivalence study. The upcoming study will include a comparator arm with Fosrenol. Unicycive plans to file the NDA in Q4 2022, indicating readiness to proceed with the remaining study.
Unicycive Therapeutics (Nasdaq: UNCY) reported its Q3 2021 financial results, showing a net loss of $5.2 million, or $0.37 per share, a dramatic rise from a $0.7 million loss in Q3 2020. Key developments include the addition to the Russell Microcap Index and the hiring of Douglas Jermasek as Executive VP of Corporate Strategy. The company anticipates confirmatory guidance from the FDA regarding its lead drug, Renazorb, aimed at treating hyperphosphatemia in chronic kidney disease, in Q4 2021.
Unicycive Therapeutics, a clinical-stage biotechnology firm focused on kidney disease therapies, has appointed Douglas Jermasek as Executive Vice President, Corporate Strategy. Jermasek brings over 25 years of industry experience, including significant roles at Akebia and Genzyme, where he drove over $1 billion in sales. His expertise in kidney disease therapy is expected to enhance Unicycive’s corporate and commercial strategies. This appointment signals the company’s commitment to addressing challenges in kidney care and advancing its lead drug, Renazorb, aimed at treating hyperphosphatemia.
Unicycive Therapeutics, Inc. (Nasdaq: UNCY) will be added to the Russell Microcap® Index on September 20, 2021, enhancing its visibility and recognition within the investment community. This membership, which lasts for one year, will link Unicycive with over $17.9 trillion in assets benchmarked to Russell indexes. CEO Shalabh Gupta emphasized that this milestone will drive further interest in Unicycive's clinical programs as a newly public company. The inclusion reflects Unicycive's market-capitalization ranking and style attributes determined by FTSE Russell.
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