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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 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.
Unicycive Therapeutics (Nasdaq: UNCY) will present at the Roth Inaugural Healthcare Opportunities Conference on October 6, 2022, in New York City. CEO Shalabh Gupta will share insights into the company's late-stage program targeting hyperphosphatemia and an early-stage program addressing mitochondrial dysfunction diseases. Investors can schedule one-on-one meetings through Roth representatives. The firm is advancing its lead drug, Renazorb, a phosphate-binding agent, and UNI-494, a new chemical entity for acute kidney injury treatment. For inquiries, investors can contact ir@unicycive.com.
Unicycive Therapeutics (Nasdaq: UNCY) announced promising preclinical results for its drug UNI-494, targeted at treating Acute Kidney Injury (AKI). In a study involving a rodent model of AKI, UNI-494 significantly reduced levels of β-2 microglobulin, a key biomarker for kidney damage. The company aims to file for regulatory approval by the end of 2022 to start a Phase 1 human study. UNI-494 works by activating mitochondrial KATP channels, potentially offering therapeutic benefits beyond AKI, including chronic kidney and liver diseases.
Unicycive Therapeutics, a clinical stage biotechnology company focused on therapies for kidney disease, announced its participation in the H.C. Wainwright 24th Annual Global Investment Conference from September 12-14, 2022. CEO Shalabh Gupta will provide a corporate overview via a virtual presentation available on demand starting at 7:00 am ET on September 12. The presentation will be accessible for 90 days on their website. Unicycive is developing innovative treatments for hyperphosphatemia and acute kidney injury.
Unicycive Therapeutics has announced the acceptance of two abstracts for presentation at the American Society of Nephrology’s Kidney Week 2022, along with a publication in the Abstract Supplement. The abstracts focus on the company’s innovative product candidates: UNI-494, aimed at reducing oxidative stress in kidney disease, and Renazorb, a phosphate binder for treating hyperphosphatemia in chronic kidney disease patients. These presentations highlight key findings that support their ongoing clinical development and potential market impact.
Unicycive Therapeutics (Nasdaq: UNCY) announced significant advancements in its product pipeline, focusing on Renazorb, a nanoparticle-based phosphate binder for Chronic Kidney Disease (CKD). The company is on track to file a New Drug Application (NDA) by the end of 2023 after signing a partnership with Lee’s Pharmaceutical for rights in China. Financially, Unicycive reported a net loss of $3.6 million for Q2 2022, with R&D expenses rising to $1.9 million. The company holds $10.6 million in cash as of June 30, 2022, ensuring funding for ongoing projects.
Unicycive Therapeutics, Inc. (Nasdaq: UNCY) has announced positive findings from a market research study indicating strong prescribing intent for its phosphate binder, Renazorb, pending FDA approval. Conducted by Reason Research, the study revealed nephrologists expect to prescribe Renazorb to 34% of dialysis patients needing phosphate binders. Key unmet needs identified include a lower pill burden and improved patient compliance, with Renazorb potentially addressing these issues. The hyperphosphatemia treatment market exceeds $1 billion in the U.S., presenting a significant commercial opportunity for Renazorb.
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