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Investing.com - H.C. Wainwright has initiated coverage on Edgewise Therapeutics (NASDAQ:EWTX) with a Buy rating and a price target of $42.00, highlighting the company’s innovative approaches to treating inherited muscle disorders. Currently trading at $13.17, the stock shows significant upside potential, with analyst targets ranging from $14 to $51. According to InvestingPro data, five analysts have recently revised their earnings expectations upward for the upcoming period.
The clinical-stage biotechnology company is advancing two key candidates in its pipeline, including sevasemten, a selective, fast myofiber myosin inhibitor designed to protect against contraction-induced muscle damage in conditions such as Becker muscular dystrophy and Duchenne muscular dystrophy. InvestingPro analysis reveals the company maintains a strong financial position with more cash than debt and a healthy current ratio of 20.99, providing ample runway for its clinical development programs.
Edgewise’s second candidate, EDG-7500, is a cardiac sarcomere modulator targeting impaired cardiac relaxation in both obstructive and non-obstructive forms of hypertrophic cardiomyopathy, with longer-term Phase 2 CIRRUS-HCM Part D results expected in the second half of 2025.
H.C. Wainwright notes that both assets have demonstrated well-tolerated safety profiles, favorable functional improvements, and positive clinical outcomes in their respective indications, positioning them for advancement to late-stage development. While the company is not yet profitable, with a market capitalization of $1.39 billion, investors can access detailed analysis and additional insights through InvestingPro’s comprehensive research reports, which cover over 1,400 US stocks.
The firm sees potential for sevasemten to become the first approved drug for Becker muscular dystrophy and an adjuvant for Duchenne muscular dystrophy standard of care, while EDG-7500 could serve as an alternative to cardiac myosin inhibitor-mediated excessive heart function reduction.
In other recent news, Edgewise Therapeutics has reported several key developments concerning its drug candidate, sevasemten, for muscular dystrophy treatments. The company announced that the U.S. Food and Drug Administration (FDA) deemed the data from its CANYON trial insufficient for accelerated approval for Becker muscular dystrophy, pushing for a traditional approval pathway instead. Despite this setback, Edgewise shared positive results from its MESA open-label extension trial, showing sustained disease stabilization in patients over three years. Additionally, Phase 2 trials for Duchenne muscular dystrophy identified a 10 mg dose for Phase 3 studies, with plans to meet the FDA in late 2025 to discuss the trial design.
Analyst firms have varied in their outlooks on Edgewise’s prospects. RBC Capital maintained an Outperform rating, expressing optimism about the potential of sevasemten and the ongoing GRAND CANYON trial. On the other hand, Stifel held a Hold rating, citing concerns about data interpretation and safety questions, particularly regarding atrial fibrillation. Meanwhile, Piper Sandler reiterated an Overweight rating, confident about upcoming regulatory updates that could enhance investor interest. These developments highlight the mixed sentiment among analysts but underscore the potential of Edgewise’s drug candidates in the muscular dystrophy landscape.
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