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On Tuesday, Mizuho (NYSE:MFG) Securities reiterated its Outperform rating on Unity Biotechnology Inc (NASDAQ:UBX) with a steady price target of $6.00, following the release of clinical trial results. The stock, currently trading at $1.30, has experienced a significant 25% decline over the past week, though InvestingPro analysis suggests the company is undervalued at current levels. Unity Biotechnology announced the outcomes from its Phase 2b ASPIRE study that compared UBX1325 to aflibercept in treating diabetic macular edema (DME). The study aimed to prove that UBX1325 was not inferior to aflibercept, a treatment marketed by Regeneron (NASDAQ:REGN) Pharmaceuticals.
Although the trial did not meet its primary endpoint based on the average change in best corrected visual acuity (BCVA) letters from baseline at weeks 20 and 24, the results were not uniformly disappointing. The underperformance of UBX1325 was isolated to the data from the 20-week mark, as it was equivalent to aflibercept at all other measured time points within the 36-week study period.
The company has reported full data for the 24-week mark and partial data for approximately 75% of participants at 36 weeks. The next steps for Unity Biotechnology involve completing the collection of the full 36-week data set, which is expected by the end of April or the beginning of May. This comprehensive data will be used to inform the design of a potential smaller pivotal study.
Unity Biotechnology’s UBX1325 is being developed as a potential treatment for DME, a condition that can lead to vision loss in people with diabetes. The ASPIRE study’s findings, despite not meeting the primary endpoint, offer insights into the efficacy of UBX1325 over an extended period, save for the 20-week time point where it fell short when compared to aflibercept. With a market capitalization of just $22 million and a strong current ratio of 2.62, InvestingPro data indicates the company maintains adequate liquidity to support its ongoing research efforts.
Investors and stakeholders in Unity Biotechnology are now looking forward to the complete 36-week data, which will provide a clearer picture of UBX1325’s performance and its future in clinical development. The company continues to focus on advancing its research in age-related diseases with the goal of halting or reversing diseases of aging. With analyst price targets ranging from $4.00 to $6.00 and the next earnings report due on April 3rd, InvestingPro subscribers can access additional insights and 8 more exclusive ProTips to better evaluate the company’s potential.
In other recent news, UNITY Biotechnology, Inc. has announced positive topline results from its Phase 2b ASPIRE clinical trial for UBX1325, a potential treatment for diabetic macular edema (DME). The trial demonstrated that UBX1325 was generally non-inferior to aflibercept, a standard therapy, in improving vision, with patients experiencing notable gains in visual acuity over a 36-week period. UNITY Biotechnology plans to advance UBX1325 to late-stage studies, aiming to provide an alternative for patients who do not respond adequately to existing therapies. In addition, Chardan Capital Markets has initiated coverage of UNITY Biotechnology with a Buy rating, highlighting the potential of UBX1325 due to its unique mechanism targeting senescent cells. In a strategic move, UNITY has appointed Federico Grossi, M.D., Ph.D., as its new chief medical officer, bringing his extensive experience in clinical development and regulatory strategy to the company. Piper Sandler has included UNITY Biotechnology among the companies with key Phase 2b readouts expected in 2025, indicating potential catalysts for the biotech firm. These developments reflect UNITY’s ongoing efforts to advance its therapeutic portfolio in the treatment of age-related diseases.
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