On Monday, Piper Sandler maintained its Overweight rating on shares of Edgewise Therapeutics (NASDAQ:EWTX), with a consistent price target of $48.00. The firm's confidence in the biotech company is primarily due to anticipated data from upcoming clinical trials. Edgewise Therapeutics is expected to release topline results in September for its EDG-7500 studies in healthy volunteers and single-dose oHCM, a condition characterized by the thickening of the heart muscle.
The analyst highlighted the significance of the upcoming topline data, emphasizing that a reduction in left ventricular outflow tract gradient (LVOT-G) by approximately 50% with less than a 5% drop in left ventricular ejection fraction (LVEF) would confirm the effectiveness of EDG-7500 independent of LVEF impact. These results are eagerly awaited as they could establish a new treatment avenue for hypertrophic cardiomyopathy (HCM).
Additionally, the firm is looking forward to the fourth quarter of 2024 when Edgewise Therapeutics is expected to share data from the CANYON study for sevasemten (EDG-5506) in Becker muscular dystrophy (BMD) and Duchenne muscular dystrophy (DMD). This data is seen as "highly de-risked" following positive Phase 1b ARCH trial results and is anticipated to further validate the GRAND CANYON study. Moreover, the Phase 2 LYNX and FOX trials, slated for the second half of 2024, are set to provide insights that will guide the next steps in DMD treatment development.
Piper Sandler expressed a strong bullish stance on Edgewise Therapeutics, citing significant potential upside ahead of several key data readouts. To offer additional insights, Piper Sandler has scheduled a two-part Becker muscular dystrophy (BMD) Key Opinion Leader (KOL) call and an Edgewise Therapeutics fireside chat on July 19, 2024, to discuss these developments further.
In other recent news, Edgewise Therapeutics has been making significant strides in its drug development programs. The biopharmaceutical company's lead drug, sevasemten, has shown promising results in clinical trials for Becker Muscular Dystrophy (BMD) and Duchenne Muscular Dystrophy (DMD), attracting attention from analysts. RBC Capital Markets has expressed confidence in Edgewise's trajectory, maintaining an Outperform rating and raising its price target.
The company's drug candidate sevasemten recently earned Orphan Drug Designations from the European Medicines Agency (EMA) for the treatment of BMD and DMD. This designation provides various incentives, including reduced regulatory fees and up to 10 years of market exclusivity upon approval.
In addition, Edgewise announced the appointment of Arlene Morris, a seasoned executive with over three decades of experience in the pharmaceutical and biotechnology sectors, to its Board of Directors. This appointment comes at a time when Edgewise is advancing its pipeline of novel therapeutics.
The company is also progressing with its '7500 cardiac program, which has been positively received by RBC Capital Markets. The firm anticipates clinical success, which is expected to be evidenced by the first-in-human data on patients and volunteers in the third quarter of 2024.
Finally, Edgewise has announced positive two-year results from its ARCH trial evaluating sevasemten in adults with BMD. The company plans to discuss these findings in a virtual investor event, providing further insights into sevasemten and its impact on BMD.
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