On Tuesday, H.C. Wainwright maintained a Buy rating and a $2.50 stock price target for Unicycive Therapeutics (NASDAQ: UNCY).
The firm's endorsement comes in light of the recent announcement that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for oxylanthanum carbonate (OLC), a treatment developed by Unicycive for hyperphosphatemia in chronic kidney disease (CKD) patients on dialysis. The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of June 28, 2025.
Unicycive is now gearing up for the potential commercialization and launch of OLC in the second half of 2025. The company is pursuing FDA approval via the 505(b)(2) regulatory pathway, which is bolstered by data from three clinical studies including a Phase 1 study in healthy volunteers, a bioequivalence study in healthy volunteers, and a pivotal study in CKD patients on dialysis.
The NDA submission also comprises data from various preclinical studies and Chemistry, Manufacturing, and Controls (CMC) related specifications and practices.
OLC's development is protected by a strong global patent portfolio, offering composition of matter exclusivity until 2031, which could extend to 2035 with a patent term extension. Additionally, the FDA has granted a waiver for the PDUFA fees for the NDA, saving Unicycive approximately $4 million.
Looking forward, Unicycive anticipates a meeting with the FDA by the end of 2024 to discuss Phase 1 results of UNI-494, which could lead to a Phase 2 study in patients with acute kidney injury (AKI). This meeting is seen as the next significant milestone for the company as it continues to advance its pipeline of kidney disease treatments.
In other recent news, Unicycive Therapeutics has been making strides in its clinical trials and regulatory endeavors. The company successfully completed a Phase 1 study for UNI-494, a drug aimed at treating acute kidney injury.
The results indicated that the drug was generally safe and well-tolerated. Unicycive also submitted a New Drug Application (NDA) for Oxylanthanum Carbonate (OLC), a treatment for hyperphosphatemia in chronic kidney disease patients on dialysis. The submission was backed by data from three clinical studies.
In addition, Unicycive is set to present new research on kidney disease therapies at the upcoming American Society of Nephrology Kidney Week. The company's research suggests that OLC may offer patient adherence benefits due to a lower pill burden compared to existing treatments.
In the wake of these developments, Unicycive received positive ratings from several analysts. H.C. Wainwright maintained its Buy rating, while Benchmark maintained a Speculative Buy rating. Despite these advancements, Unicycive faces potential delisting from the Nasdaq Market due to non-compliance with the exchange's listing rules. These are the recent developments for Unicycive Therapeutics.
InvestingPro Insights
Unicycive Therapeutics' recent developments align with several key insights from InvestingPro. The company's focus on advancing its kidney disease treatments, particularly OLC, is reflected in its financial position and market performance.
According to InvestingPro data, Unicycive has a market capitalization of $50.31 million USD, indicating its relatively small size in the biotech sector. This aligns with the company's current stage of development, as it prepares for potential commercialization of OLC in 2025.
Two relevant InvestingPro Tips highlight the company's financial situation. Firstly, Unicycive "holds more cash than debt on its balance sheet," which is crucial for a biotech company in the pre-revenue stage, especially as it prepares for potential product launch. Secondly, the company is "quickly burning through cash," which is typical for biotech firms investing heavily in R&D and preparing for commercialization.
The stock has shown strong recent performance, with a 44.11% return over the last month and a 55.14% return over the last three months. This positive momentum could be attributed to the FDA's acceptance of the NDA for OLC and the approaching PDUFA date.
It's worth noting that InvestingPro offers 12 additional tips for Unicycive Therapeutics, providing a more comprehensive analysis for investors interested in the company's prospects.
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