Unicycive Therapeutics OLC New Drug Application Accepted by FDA
Written by Emily J. Thompson, Senior Investment Analyst
Updated: 4d ago
0mins
Should l Buy UNCY?
Unicycive Therapeutics announced that the U.S. Food and Drug Administration, FDA, has accepted the resubmission of its New Drug Application, NDA, for oxylanthanum carbonate, OLC, the Company's investigational oral phosphate binder for the treatment of hyperphosphatemia in patients with chronic kidney disease, CKD, on dialysis. The Agency has deemed the OLC resubmission to be a Class II complete response which has a six-month review period from the date of resubmission and set a Prescription Drug User Fee Act, PDUFA, target action date of June 27, 2026. "We are pleased that the agency has promptly accepted the resubmission of our NDA for OLC," said Shalabh Gupta, M.D., Chief Executive Officer of Unicycive. "We are advancing our commercial preparation activities in anticipation of a potential launch of OLC later this year, to help provide an important treatment option to patients with chronic kidney disease on dialysis who continue to struggle with hyperphosphatemia."
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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.
See More
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.
See More
Unicycive's Drug Application Accepted by FDA
- Drug Application Progress: Unicycive's oxylanthanum carbonate (OLC) New Drug Application has been accepted by the FDA, with a review period ending on June 27, 2026, laying the groundwork for the company's market launch among chronic kidney disease patients.
- Strong Financial Position: Unicycive ended 2025 with $41.3 million in cash and short-term investments, ensuring continued advancement of OLC's commercialization activities into 2027, thereby enhancing its competitive edge in the market.
- Clinical Research Support: The NDA for OLC is backed by data from three clinical studies and multiple preclinical studies, with the FDA raising no concerns regarding its safety or efficacy, providing robust support for the drug's approval.
- Significant Market Potential: As a novel oral phosphate binder, OLC is expected to significantly improve treatment adherence among chronic kidney disease patients, addressing the urgent needs of over 450,000 individuals in the U.S. requiring medication to control phosphate levels annually.
See More
Unicycive Resubmits NDA for OLC to Treat Hyperphosphatemia in CKD Patients
- NDA Resubmission: Unicycive Therapeutics has resubmitted its New Drug Application for oxylanthanum carbonate (OLC) to the FDA, aimed at treating hyperphosphatemia in chronic kidney disease patients on dialysis, marking a significant step in addressing previously cited deficiencies.
- Compliance Progress: The resubmission follows substantial progress by the company's original third-party manufacturing vendor in rectifying issues identified by the FDA, demonstrating the company's commitment to regulatory compliance.
- Financial Stability: CEO Shalabh Gupta noted that with a cash runway extending into 2027, the company is well-positioned to complete the regulatory process and prepare for a potential OLC launch, which enhances market confidence.
- Stock Price Increase: Following the resubmission announcement, Unicycive's shares closed at $6.07 on Friday, reflecting a 3.58% increase, indicating investor optimism regarding the company's future prospects.
See More
Unicycive Resubmits OLC NDA to FDA, Cash Runway Until 2027
- Regulatory Progress: Unicycive has resubmitted its New Drug Application (NDA) for oxylanthanum carbonate (OLC) to the FDA, based on significant progress by the original third-party manufacturer in addressing FDA-cited deficiencies, which is expected to expedite treatment options for CKD patients.
- Financial Assurance: The company stated that with a cash runway extending into 2027, it is well-positioned to complete the regulatory approval process for OLC, thereby providing an important treatment option for kidney disease patients and enhancing its market competitiveness.
- Clinical Data Support: The NDA submission is based on data from three clinical studies, demonstrating OLC's potential as an oral phosphate binder, which may offer better patient adherence compared to existing treatment options, addressing a critical market need.
- Patent Protection: OLC is backed by a strong global patent portfolio, ensuring composition of matter exclusivity until 2031, with potential extensions until 2035, thereby strengthening the company's long-term strategic position in the kidney disease treatment sector.
See More
Unicycive Resubmits OLC NDA to FDA, Cash Runway Until 2027
- Regulatory Progress: Unicycive has resubmitted its New Drug Application (NDA) for oxylanthanum carbonate (OLC) to the FDA, based on significant progress by the original third-party manufacturer in addressing FDA-cited deficiencies, thereby providing a new treatment option for chronic kidney disease patients.
- Financial Assurance: The company stated that with a cash runway extending into 2027, Unicycive is well-positioned to complete the regulatory approval process for OLC, ensuring that this important treatment can be brought to market as soon as possible.
- Clinical Data Support: The NDA submission for OLC is based on data from three clinical studies, demonstrating its potential in treating hyperphosphatemia, which may significantly improve patient adherence by reducing pill burden.
- Market Demand: In the U.S., over 450,000 dialysis patients face the challenge of hyperphosphatemia annually, and the approval of OLC will help meet this urgent medical need, enhancing patients' quality of life.
See More
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.
See More
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.
See More
Unicycive's Drug Application Accepted by FDA
- Drug Application Progress: Unicycive's oxylanthanum carbonate (OLC) New Drug Application has been accepted by the FDA, with a review period ending on June 27, 2026, laying the groundwork for the company's market launch among chronic kidney disease patients.
- Strong Financial Position: Unicycive ended 2025 with $41.3 million in cash and short-term investments, ensuring continued advancement of OLC's commercialization activities into 2027, thereby enhancing its competitive edge in the market.
- Clinical Research Support: The NDA for OLC is backed by data from three clinical studies and multiple preclinical studies, with the FDA raising no concerns regarding its safety or efficacy, providing robust support for the drug's approval.
- Significant Market Potential: As a novel oral phosphate binder, OLC is expected to significantly improve treatment adherence among chronic kidney disease patients, addressing the urgent needs of over 450,000 individuals in the U.S. requiring medication to control phosphate levels annually.
See More
Unicycive Resubmits NDA for OLC to Treat Hyperphosphatemia in CKD Patients
- NDA Resubmission: Unicycive Therapeutics has resubmitted its New Drug Application for oxylanthanum carbonate (OLC) to the FDA, aimed at treating hyperphosphatemia in chronic kidney disease patients on dialysis, marking a significant step in addressing previously cited deficiencies.
- Compliance Progress: The resubmission follows substantial progress by the company's original third-party manufacturing vendor in rectifying issues identified by the FDA, demonstrating the company's commitment to regulatory compliance.
- Financial Stability: CEO Shalabh Gupta noted that with a cash runway extending into 2027, the company is well-positioned to complete the regulatory process and prepare for a potential OLC launch, which enhances market confidence.
- Stock Price Increase: Following the resubmission announcement, Unicycive's shares closed at $6.07 on Friday, reflecting a 3.58% increase, indicating investor optimism regarding the company's future prospects.
See More
Unicycive Resubmits OLC NDA to FDA, Cash Runway Until 2027
- Regulatory Progress: Unicycive has resubmitted its New Drug Application (NDA) for oxylanthanum carbonate (OLC) to the FDA, based on significant progress by the original third-party manufacturer in addressing FDA-cited deficiencies, which is expected to expedite treatment options for CKD patients.
- Financial Assurance: The company stated that with a cash runway extending into 2027, it is well-positioned to complete the regulatory approval process for OLC, thereby providing an important treatment option for kidney disease patients and enhancing its market competitiveness.
- Clinical Data Support: The NDA submission is based on data from three clinical studies, demonstrating OLC's potential as an oral phosphate binder, which may offer better patient adherence compared to existing treatment options, addressing a critical market need.
- Patent Protection: OLC is backed by a strong global patent portfolio, ensuring composition of matter exclusivity until 2031, with potential extensions until 2035, thereby strengthening the company's long-term strategic position in the kidney disease treatment sector.
See More
Unicycive Resubmits OLC NDA to FDA, Cash Runway Until 2027
- Regulatory Progress: Unicycive has resubmitted its New Drug Application (NDA) for oxylanthanum carbonate (OLC) to the FDA, based on significant progress by the original third-party manufacturer in addressing FDA-cited deficiencies, thereby providing a new treatment option for chronic kidney disease patients.
- Financial Assurance: The company stated that with a cash runway extending into 2027, Unicycive is well-positioned to complete the regulatory approval process for OLC, ensuring that this important treatment can be brought to market as soon as possible.
- Clinical Data Support: The NDA submission for OLC is based on data from three clinical studies, demonstrating its potential in treating hyperphosphatemia, which may significantly improve patient adherence by reducing pill burden.
- Market Demand: In the U.S., over 450,000 dialysis patients face the challenge of hyperphosphatemia annually, and the approval of OLC will help meet this urgent medical need, enhancing patients' quality of life.
See More
