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.
Unicycive Therapeutics (UNCY) announced the publication of positive bioequivalence data for oxylanthanum carbonate (OLC) in Clinical Therapeutics journal. The study demonstrated pharmacodynamic bioequivalence between OLC and Fosrenol® (lanthanum carbonate) in treating hyperphosphatemia in kidney disease patients.
The randomized crossover study involved 80 participants, with 75 completing all doses. Results showed similar least squares mean change in urinary phosphate excretion: OLC (-320.4 mg/day) versus LC (-324.0 mg/day), with a between-group difference of 3.6 mg/day. Both treatments were well-tolerated with comparable adverse event profiles. The company's New Drug Application for OLC is under review, with commercial launch planned for 2025.
Unicycive Therapeutics (Nasdaq: UNCY), a clinical-stage biotech focusing on kidney disease therapies, announced its participation in two upcoming investor conferences. CEO Shalabh Gupta will deliver a corporate presentation at the Noble Capital Markets 20th Annual Emerging Growth Equity Conference on December 3, 2024, at 3:00 p.m. ET in Boca Raton, FL. Additionally, he will participate in a fireside chat at the Piper Sandler 36th Annual Healthcare Conference on December 5, 2024, at 12:30 p.m. ET in New York. Live and archived webcasts will be available on Unicycive's website under the Investors section.
Unicycive Therapeutics (UNCY) reported Q3 2024 financial results and business updates. Key highlights include FDA acceptance of the New Drug Application for oxylanthanum carbonate (OLC) with a PDUFA date of June 28, 2025, and successful completion of UNI-494 Phase 1 trial. Q3 financial results showed R&D expenses of $3.0M (down from $3.4M in Q3 2023), G&A expenses of $3.2M (up from $2.6M), and a net loss of $4.1M (improved from $4.4M). Cash position stands at $32.3M, sufficient to fund operations into 2026.
Unicycive Therapeutics announced FDA acceptance of its New Drug Application (NDA) for Oxylanthanum Carbonate (OLC) for treating hyperphosphatemia in chronic kidney disease patients on dialysis. The FDA set a PDUFA target date of June 28, 2025. OLC aims to reduce treatment burden by requiring fewer and smaller pills that can be swallowed rather than chewed. The NDA submission includes data from three clinical studies and is seeking approval via the 505(b)(2) pathway. The company received an FDA fee waiver, saving approximately $4 million, and is preparing for commercial launch in second half of 2025 if approved.
Unicycive Therapeutics (UNCY) presented multiple studies at ASN Kidney Week 2024, highlighting progress on oxylanthanum carbonate (OLC) and UNI-494. The late-breaking presentation showed OLC enabled serum phosphate control in >90% of chronic kidney disease patients on dialysis who entered maintenance phase, with 69% achieving target levels at ≤1500 mg/day. The company also presented positive Phase 1 safety data for UNI-494. Two recent publications featured preclinical studies for both compounds. OLC demonstrated synergistic effects when combined with tenapanor in rat studies, while UNI-494 showed potential in treating acute kidney injury.
Unicycive Therapeutics (Nasdaq: UNCY), a clinical-stage biotechnology company focused on kidney disease therapies, has announced its participation in the 2024 Maxim Healthcare Virtual Summit. The company's CEO, Shalabh Gupta, M.D., will engage in a fireside chat on October 17, 2024, at 10:00 a.m. ET.
Interested parties can access the live and archived webcast through the Unicycive website under the Investors section, specifically in the Events and Presentations area. The webcast archive will remain available for three months following the event.
This participation provides an opportunity for investors and stakeholders to gain insights into Unicycive's developments and strategies in the field of kidney disease treatments.
Unicycive Therapeutics (Nasdaq: UNCY) announced a late-breaker poster presentation on oxylanthanum carbonate (OLC) at the American Society of Nephrology (ASN) Kidney Week 2024. The presentation, titled 'Effects of Oxylanthanum Carbonate in Patients Receiving Maintenance Hemodialysis with Hyperphosphatemia,' will be led by Dr. Geoffrey A. Block. Additionally, Unicycive will deliver three more poster presentations on OLC and UNI-494.
The conference will take place from October 24-27, 2024, in San Diego, CA. The additional presentations will cover topics such as the effects of intravenous UNI-494 on acute kidney injury, the combination of OLC and tenapanor in lowering urinary phosphate excretion, and the Phase I safety, tolerability, and pharmacokinetics of UNI-494. These presentations highlight Unicycive's ongoing research in kidney disease treatments.
Unicycive Therapeutics (Nasdaq: UNCY) has successfully completed the Phase 1 study of UNI-494 in healthy volunteers. The study, conducted in the UK, assessed safety, tolerability, and pharmacokinetics of UNI-494. Key findings include:
1. Single Ascending Dose: Well-tolerated from 10 mg to 160 mg with no serious adverse events.
2. Multiple Ascending Dose: Safe and well-tolerated at 40 mg twice daily for 5 days.
3. Pharmacokinetics: Rapid absorption and metabolism of UNI-494, releasing nicorandil.
The company plans to request an FDA meeting to review results and discuss potential Phase 2 study design for acute kidney injury patients. CEO Shalabh Gupta called this an important milestone for UNI-494's clinical development.
Unicycive Therapeutics (Nasdaq: UNCY), a clinical-stage biotech company focused on kidney disease therapies, has announced its participation in the virtual Lytham Partners Fall 2024 Investor Conference. Dr. Shalabh Gupta, the company's CEO, will engage in a fireside chat on October 1, 2024, at 11:00 a.m. ET.
Investors and interested parties can access the live webcast and archived recording through the Unicycive website's Investor section under Events and Presentations. The archived webcast will remain available for three months following the event, providing an extended opportunity for those unable to attend the live session.
Unicycive Therapeutics (Nasdaq: UNCY), a clinical-stage biotech company focused on kidney disease treatments, has announced its participation in the upcoming Virtual Life Sciences Investor Forum. Dr. Shalabh Gupta, the company's CEO, will deliver a corporate update on September 19, 2024, at 2:00 p.m. ET.
Investors can access the live and archived webcast through the Unicycive website's Investors section under Events and Presentations. Pre-registration is recommended for online participants to ensure smooth access and receive event updates. The webcast archive will remain available for three months following the presentation.
FAQ
What is the current stock price of Unicycive Therapeutics (UNCY)?
What is the market cap of Unicycive Therapeutics (UNCY)?
What is Unicycive Therapeutics, Inc.?
What is Renazorb?
What is UNI-494?
What are hyperphosphatemia and its complications?
What is Delayed Graft Function (DGF)?
What is the market opportunity for Renazorb?
Who are the major investors in Unicycive?
When will the topline data be available?
How can I contact Unicycive for investor inquiries?
What is the significance of UNI-494's orphan drug designation?
