Unicycive Therapeutics Inc Stock Price, News & Analysis

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.

Unicycive Therapeutics (Nasdaq: UNCY) has been granted U.S. Patent No. 12,036,211 by the USPTO for UNI-494, ensuring intellectual property protection until 2040. The patent covers a method of treating acute kidney injury or contrast-induced nephropathy using the UNI-494 compound, a novel nicotinamide ester derivative and selective ATP-sensitive mitochondrial potassium channel activator.

UNI-494 is currently in a Phase 1 clinical trial and has received Orphan Drug Designation for Delayed Graft Function, a form of acute kidney injury. This patent is a important component of Unicycive's strategy to become a leader in developing drugs targeting kidney disease.

Unicycive Therapeutics (Nasdaq: UNCY), a clinical-stage biotech company focused on kidney disease therapies, announced participation in the H.C. Wainwright 3rd Annual Kidney Virtual Conference. CEO Shalabh Gupta, M.D. will engage in a Fireside Chat on July 15, 2024, at 2:00 p.m. ET. The event will be accessible live and as an archived webcast for three months on Unicycive's website under the Investors section: Events and Presentations.

Unicycive Therapeutics announced positive initial patient satisfaction results from its pivotal clinical trial for oxylanthanum carbonate (OLC) in patients with hyperphosphatemia who have chronic kidney disease on dialysis. The survey, part of the UNI-OLC-201 trial, revealed that 79% of patients preferred OLC over their previous phosphate binders, with 98% finding it easy to take compared to 55% for their prior medication. Additionally, 89% of patients reported satisfaction with OLC versus 49% for their previous therapy. The median daily pill burden was halved when switching to OLC. These findings support the potential best-in-class profile of OLC, and the company plans to file a New Drug Application soon.

Unicycive Therapeutics (Nasdaq: UNCY), a clinical-stage biotechnology company, announced its inclusion in the Russell Microcap Index, effective July 1, 2024. This follows the annual reconstitution of the Russell US Indexes, which ranks the 4,000 largest US stocks by market capitalization. Membership in the index lasts for one year and includes automatic inclusion in relevant growth and value style indexes. The company believes this milestone will boost its visibility among investors, furthering momentum gained from recent positive clinical trial results for oxylanthanum carbonate (OLC).