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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 (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.
Unicycive Therapeutics (Nasdaq: UNCY), a clinical-stage biotech company focused on kidney disease therapies, has announced its participation in the H.C. Wainwright 26th Annual Global Investment Conference. The company's CEO, Dr. Shalabh Gupta, is scheduled to present a corporate update on September 10, 2024, at 10:30 a.m. ET in New York.
Investors and interested parties can access the live and archived webcast of the presentation through the Unicycive website's Investors section under Events and Presentations. The archived webcast will remain available for three months following the event, providing an extended opportunity for stakeholders to gain insights into the company's latest developments and strategic direction.
Unicycive Therapeutics (Nasdaq: UNCY) has submitted a New Drug Application (NDA) to the FDA for Oxylanthanum Carbonate (OLC) to treat hyperphosphatemia in chronic kidney disease patients on dialysis. The company is seeking approval via the 505(b)(2) regulatory pathway, aiming to provide a differentiated, best-in-class therapy with reduced pill burden. The NDA is based on data from three clinical studies, preclinical studies, and CMC specifications.
Notably, the FDA granted a waiver for the NDA application PDUFA fees, saving Unicycive approximately $4 million. The company is now preparing for a potential market launch, pending FDA approval. This submission marks a significant milestone in Unicycive's mission to improve treatment options for CKD patients with hyperphosphatemia.
Unicycive Therapeutics (Nasdaq: UNCY) has announced three poster presentations at the American Society of Nephrology (ASN) Kidney Week 2024, taking place October 24-27 in San Diego. The presentations will showcase data on the company's product candidates:
1. Intravenous UNI-494 for acute kidney injury
2. Combination of oxylanthanum carbonate and tenapanor for lowering urinary phosphate excretion
3. UNI-494 Phase I safety, tolerability, and pharmacokinetics
CEO Shalabh Gupta expressed enthusiasm about the strong interest from the medical community in both oxylanthanum carbonate (OLC) and UNI-494. The presentations will cover preclinical and clinical data, highlighting Unicycive's progress in developing therapies for patients with kidney disease.
Unicycive Therapeutics (UNCY) reported Q2 2024 financial results and provided a business update. Key highlights include:
1. On track to submit OLC New Drug Application (NDA) by end of August 2024.
2. Positive topline data from OLC pivotal trial, with 90% of patients achieving phosphate control.
3. Completed enrollment in UNI-494 Phase 1 study, results expected in Q3 2024.
4. Granted new patent for UNI-494 to treat acute kidney injury (AKI).
5. Q2 2024 financial results: R&D expenses $4.9M, G&A expenses $2.5M, net income $3.0M (EPS $0.08 basic, -$0.15 diluted).
6. Cash position of $41.8M, sufficient to fund operations into 2026.
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