Unicycive Therapeutics to Present at the Virtual Life Sciences Investor Forum on September 19, 2024
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Sep 16 2024
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Source: Newsfilter
Corporate Update Presentation: Unicycive Therapeutics will present a corporate update at the Virtual Life Sciences Investor Forum on September 19, 2024, led by CEO Shalabh Gupta, M.D.
Company Overview: Unicycive is focused on developing therapies for kidney diseases, including its lead drug candidate oxylanthanum carbonate for hyperphosphatemia in chronic kidney disease patients.
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Analyst Views on UNCY
Wall Street analysts forecast UNCY stock price to rise over the next 12 months. According to Wall Street analysts, the average 1-year price target for UNCY is 35.80 USD with a low forecast of 21.00 USD and a high forecast of 60.00 USD. However, analyst price targets are subjective and often lag stock prices, so investors should focus on the objective reasons behind analyst rating changes, which better reflect the company's fundamentals.
5 Analyst Rating
5 Buy
0 Hold
0 Sell
Strong Buy
Current: 5.970
Low
21.00
Averages
35.80
High
60.00
Current: 5.970
Low
21.00
Averages
35.80
High
60.00
About UNCY
Unicycive Therapeutics, Inc. is a biotechnology company developing treatments for kidney diseases. The Company's lead drug candidate, oxylanthanum carbonate (OLC), is an investigational phosphate binding agent being developed for the treatment of hyperphosphatemia in chronic kidney disease patients on dialysis. Its second asset, UNI-494, is a patent-protected new chemical entity in clinical development for the treatment of conditions related to acute kidney injury.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
Unicycive's Drug Application Accepted by FDA with Target Date Set
- FDA Acceptance: Unicycive's New Drug Application for oxylanthanum carbonate (OLC) has been accepted by the FDA, with a Prescription Drug User Fee Act (PDUFA) target action date set for June 29, 2026, marking a significant advancement in chronic kidney disease treatment.
- Strong Financial Position: Unicycive ended 2025 with an unaudited cash position of $41.3 million, which is expected to support its OLC commercialization activities into 2027, ensuring ongoing investment in research and market launch efforts.
- Clinical Research Support: The NDA for OLC is backed by data from three clinical studies, demonstrating its potential in treating hyperphosphatemia, and the FDA raised no concerns regarding its safety or efficacy data, bolstering market confidence.
- Strong Market Demand: Hyperphosphatemia is prevalent among end-stage renal disease patients, with over 450,000 individuals annually requiring medication to control phosphate levels, and the launch of OLC will provide a crucial treatment option for this large patient population, indicating significant market potential.
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Unicycive's Kidney Disease Therapy NDA Accepted by FDA
- Drug Application Progress: Unicycive Therapeutics announced that the FDA has accepted its New Drug Application for oxylanthanum carbonate, marking a significant advancement in treating hyperphosphatemia in chronic kidney disease patients.
- FDA Review Timeline: The FDA has set a target action date of June 27, 2026, indicating that the resubmission is classified as a Class II complete response, which entails a six-month review period.
- Financial Position: As of the end of 2025, Unicycive reported $41.3 million in cash and short-term investments, demonstrating the company's capacity to support future drug launch activities.
- Market Outlook: The company noted that its current liquidity position could facilitate potential launch activities for OLC and extend its cash runway into 2027, enhancing its competitive stance in the market.
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