On Thursday, H.C. Wainwright maintained a bullish stance on shares of Unicycive Therapeutics (NASDAQ: UNCY), reiterating a Buy rating and a $4.50 price target. This follows the release of preliminary survey results from a pivotal trial for the company's drug oxylanthanum carbonate (OLC), which is designed for patients with hyperphosphatemia undergoing dialysis due to chronic kidney disease (CKD).
The survey, part of the UNI-OLC-201 pivotal trial, revealed a strong patient preference for OLC over previous phosphate binders. Out of the 128 patients screened, a notable 79% preferred OLC compared to 18% who favored their prior medications. The survey also indicated a significant increase in patient satisfaction after switching to OLC, with satisfaction rates soaring from 49% with previous treatments to 89% with OLC.
The trial included patients who had been treated with various phosphate binders, including Renvela, PhosLo, Auryxia, and Velphoro, with a small percentage using other therapies. A two-week washout period was implemented to eliminate the effects of their former medications before starting OLC treatment.
The positive feedback from the patient-reported outcome survey adds to the favorable top-line data from the pivotal trial announced on June 25. The earlier results highlighted OLC's tolerability, safety, and efficacy, along with the potential for a reduced pill burden for patients.
Unicycive Therapeutics is expected to file a New Drug Application (NDA) for OLC in the third quarter of 2024. The company's focus on addressing the needs of CKD patients undergoing dialysis has been reinforced by the recent survey results, which could play a pivotal role in the drug's path to market approval.
In other recent news, Unicycive Therapeutics has reported significant developments. The company has released positive results from its UNI-OLC-201 clinical trial for oxylanthanum carbonate (OLC), indicating a strong patient preference for this potential treatment for hyperphosphatemia in chronic kidney disease patients. Moreover, Unicycive has expanded its manufacturing agreement with Shilpa Medicare to meet anticipated increased manufacturing needs for OLC.
The biotech firm also announced that it has doubled its authorized shares from 200 million to 400 million. This move could potentially facilitate capital raising, fund new research and development, or enable other corporate activities.
Investment firms H.C. Wainwright, Noble Capital, and Piper Sandler have shown confidence in Unicycive, maintaining positive ratings and setting price targets for the company's shares. These recent developments suggest an ongoing belief in the potential of Unicycive's therapy to address the needs of patients with chronic kidney disease undergoing dialysis.
Finally, Unicycive is expected to report top-line data from a 16-week Phase 2 trial evaluating OLC's tolerability in chronic kidney disease patients on dialysis in 2024, along with a New Drug Application for OLC anticipated by mid-2024, with potential approval by mid-2025.
InvestingPro Insights
Amid H.C. Wainwright's endorsement of Unicycive Therapeutics, current financial metrics from InvestingPro paint a nuanced picture for investors. With a market cap of just $18.24 million, UNCY's balance sheet shows a preference for liquidity, as it holds more cash than debt.
Still, the company's aggressive cash burn rate and weak gross profit margins suggest a challenging financial landscape. The stock's price volatility is also noteworthy, with a significant 61.13% drop over the last three months, and a 45.71% decline over the last six months, reflecting investor uncertainty.
InvestingPro Tips highlight that analysts do not expect Unicycive Therapeutics to be profitable this year, and the company does not pay a dividend, which could be a consideration for income-focused investors. Moreover, there are 10 more tips available on InvestingPro for those who wish to delve deeper into UNCY's financial health and stock performance. For those interested, use the coupon code PRONEWS24 to get up to 10% off a yearly Pro and a yearly or biyearly Pro+ subscription, which could provide further valuable insights into your investment decisions.
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