On Monday, Unicycive Therapeutics (NASDAQ:UNCY) shares maintained a Buy rating and a price target of $2.50 from H.C. Wainwright after the Food and Drug Administration (FDA) accepted the New Drug Application (NDA) for oxylanthanum carbonate (OLC).
OLC is a phosphate binding agent designed to treat hyperphosphatemia in patients with chronic kidney disease (CKD) undergoing dialysis. The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date for June 28, 2025.
The ongoing NDA review has prompted Unicycive to gear up for the potential commercial launch of OLC in the second half of 2025. The company is seeking approval through the 505(b)(2) regulatory pathway, which is supported by data from three clinical studies: a Phase 1 study in healthy volunteers, a bioequivalence study in healthy volunteers, and a pivotal study in CKD patients on dialysis.
Additional support comes from multiple preclinical studies and Chemistry, Manufacturing, and Controls (CMC)-related specifications and practices included in the NDA submission.
OLC's patent protection is robust, with issued patents on the composition of matter providing exclusivity until 2031, and there is a possibility for patent term extension until 2035. The financial position of Unicycive is further strengthened as the FDA granted a waiver for the NDA's PDUFA fees, which amounts to a savings of approximately $4 million.
Looking ahead, Unicycive anticipates a meeting with the FDA by the end of 2024 to discuss Phase 1 results of another clinical candidate, UNI-494, which is intended for a potential Phase 2 study in patients with acute kidney injury (AKI). This meeting is expected to be the next significant milestone for the company as it continues to advance its pipeline.
In other recent news, Unicycive Therapeutics has made significant strides in its clinical trials and regulatory endeavors. The company has successfully completed its UNI-494 Phase 1 study, potentially paving the way for a Phase 2 trial in patients with acute kidney injury.
Alongside this, Unicycive has submitted a New Drug Application (NDA) for Oxylanthanum Carbonate (OLC), a treatment for hyperphosphatemia in chronic kidney disease patients on dialysis. This application is supported by data from three clinical studies and additional preclinical data.
Furthermore, Unicycive has announced its participation in the upcoming American Society of Nephrology (ASN) Kidney Week 2024, where it will present new research on therapies for kidney disease. These recent developments highlight Unicycive Therapeutics' ongoing efforts in its clinical trials and regulatory endeavors.
InvestingPro Insights
Unicycive Therapeutics' recent FDA acceptance of its NDA for oxylanthanum carbonate aligns with several key financial indicators and trends highlighted by InvestingPro. The company's market capitalization stands at $50.31 million, reflecting its current position as a smaller player in the biotech space with significant growth potential.
InvestingPro Tips reveal that Unicycive holds more cash than debt on its balance sheet, which is crucial for a biotech company advancing through clinical trials and preparing for potential commercialization. This financial stability is particularly important as the company gears up for the possible launch of OLC in the second half of 2025.
Additionally, InvestingPro data shows a strong return of 44.11% over the last month and 55.14% over the last three months, indicating growing investor confidence in Unicycive's prospects. This positive momentum could be attributed to the FDA's acceptance of the NDA and the waiver of PDUFA fees, which saves the company approximately $4 million.
However, it's worth noting that Unicycive is not currently profitable, with a negative P/E ratio of -2.06 for the last twelve months as of Q2 2024. This is not uncommon for biotech companies in the development stage, and the InvestingPro Tip suggesting that analysts do not anticipate profitability this year aligns with the company's focus on advancing its pipeline rather than immediate revenue generation.
For investors seeking a more comprehensive analysis, InvestingPro offers 12 additional tips for Unicycive Therapeutics, providing a deeper understanding of the company's financial health and market position.
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