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Tuesday, H.C. Wainwright maintained a Buy rating on Unicycive Therapeutics (NASDAQ:UNCY), currently trading at $0.57, and raised the price target to $7.50, up from $4.00. The stock has seen significant volatility, with a 52% gain over the past six months despite a recent 9.5% weekly decline. The firm’s analyst cited upcoming milestones for the company, including a PDUFA date and an anticipated commercial launch of its lead asset, as reasons for the increased target.
Unicycive Therapeutics is approaching a significant regulatory milestone with the Prescription Drug User Fee Act (PDUFA) date set for June 28, 2025. This date is critical for the company’s New Drug Application (NDA) for oxylanthanum carbonate (OLC), which is being developed to treat hyperphosphatemia in chronic kidney disease (CKD) patients on dialysis. According to InvestingPro data, analyst targets for the stock range from $3.00 to $9.00, reflecting strong confidence in the potential approval.
The analyst at H.C. Wainwright expressed confidence in the stock, noting that the NDA has been substantially de-risked due to its 505(b)(2) regulatory pathway. As the PDUFA date draws closer, the firm anticipates a rise in Unicycive’s stock value, in light of the likely approval of OLC.
Unicycive Therapeutics is also preparing for the commercial launch of OLC, expected to occur in late 2025. This event is projected to be a key driver for the company’s growth and is a factor in the raised price target.
Despite the challenges posed by various macroeconomic and policy changes in the biopharmaceutical space, the analyst remains optimistic about Unicycive’s prospects. The updated model and analysis led to the decision to increase the one-year price target on the company’s shares to $7.50. The Buy rating has been reaffirmed, signaling the analyst’s continued positive outlook on the stock. InvestingPro analysis shows the company maintains a healthy balance sheet with more cash than debt and a strong current ratio of 3.61, though it’s currently burning through cash. Get access to 8 more exclusive InvestingPro Tips and comprehensive financial metrics to make better-informed investment decisions.
In other recent news, Unicycive Therapeutics has shared promising developments regarding their lead drug candidate, oxylanthanum carbonate (OLC), aimed at treating hyperphosphatemia in chronic kidney disease patients. The company announced positive data from a Phase 1 study showing that OLC was well-tolerated and effectively reduced phosphate absorption in healthy volunteers. Unicycive is actively seeking FDA approval for OLC, with a decision expected by June 28, 2025. Additionally, Unicycive has highlighted challenges in phosphate management, noting high non-adherence rates to current therapies due to factors like large pill size and unpleasant side effects. The company believes OLC could address these issues with its smaller pill size and lower pill burden.
Furthermore, Unicycive has been granted an extension by Nasdaq to meet the minimum bid price requirement, now having until July 7, 2025, to comply. This follows a previous notice regarding non-compliance due to the stock’s bid price falling below $1.00 per share. The company is exploring strategies to regain compliance and maintain its Nasdaq listing. These developments underscore Unicycive’s ongoing efforts to improve treatment options for kidney disease patients while navigating regulatory and market challenges.
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