On Thursday, H.C. Wainwright maintained its Buy rating and $2.50 stock price target for NASDAQ:UNCY, following the announcement of successful Phase 1 study results for its drug candidate UNI-494. The study reported that UNI-494 was well-tolerated in healthy volunteers at single doses up to 160 mg and multiple doses of 40 mg twice daily.
The study, which was a double-blind, placebo-controlled, randomized trial conducted in the UK, primarily focused on the safety, tolerability, and pharmacokinetics (PK) of UNI-494. It involved 40 participants across five cohorts for single ascending doses, ranging from 10 mg to 160 mg, and 19 participants across two cohorts for multiple ascending doses.
In the first part of the study, 30 participants received UNI-494, and 10 received a placebo. The results indicated that UNI-494 was generally safe and well-tolerated, with headache being the most common mild adverse event. There were no serious adverse events or withdrawals due to adverse events in this part of the trial.
The second part of the study, which involved dosing participants with 40 mg of UNI-494 twice daily for five days, showed mostly mild adverse events, including headache, nausea, and vomiting, with one discontinuation. However, there were tolerability challenges in the second cohort, which received 80 mg twice daily, leading to four participants withdrawing due to adverse events.
The PK results of the study indicated fast absorption and rapid metabolism of UNI-494, leading to the expected release of nicorandil and its linker. The plasma concentrations of nicorandil increased slightly more than proportionally with the increasing dosages. The affirmation of the Buy rating and $2.50 price target reflects the analyst's outlook following these study results.
In other recent news, Unicycive Therapeutics has made substantial progress in its clinical trials and regulatory endeavors. The company successfully completed its UNI-494 Phase 1 study, which could pave the way for a Phase 2 trial for patients with acute kidney injury. The biotech firm also submitted a New Drug Application (NDA) for Oxylanthanum Carbonate (OLC), a treatment for hyperphosphatemia in chronic kidney disease patients on dialysis, backed by data from three clinical studies.
Benchmark and H.C. Wainwright have maintained their positive ratings for Unicycive, with H.C. Wainwright adjusting its stock price target to $2.50. However, 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 in Unicycive Therapeutics' journey.
InvestingPro Insights
Recent InvestingPro data provides additional context to Unicycive Therapeutics' (NASDAQ:UNCY) financial position and market performance. The company's market capitalization stands at $34.25 million, reflecting its current valuation in the biotech sector. UNCY's stock has experienced significant volatility, with a 72.16% price decline over the past six months, aligning with the challenging landscape often faced by early-stage pharmaceutical companies.
InvestingPro Tips highlight that UNCY holds more cash than debt on its balance sheet, which could be crucial for funding ongoing clinical trials like the recently reported Phase 1 study for UNI-494. However, the company is quickly burning through cash, a common characteristic of biotech firms investing heavily in research and development. This cash burn rate underscores the importance of successful clinical outcomes, such as the positive Phase 1 results, in potentially attracting further investment or partnerships.
It's worth noting that analysts do not anticipate profitability for UNCY this year, which is not unusual for companies at this stage of drug development. The absence of dividends and negative earnings per share (-$0.70 diluted EPS) further emphasize the company's focus on research and development rather than immediate profitability.
For investors seeking a more comprehensive analysis, InvestingPro offers additional tips and insights, with 10 more tips available for UNCY on the platform.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.