S&P 500 slips, but losses kept in check as Nvidia climbs ahead of results
Investing.com - Stifel maintained its Hold rating and $16.00 price target on Edgewise Therapeutics (NASDAQ:EWTX) stock Wednesday, citing ongoing concerns about the company’s sevasemten clinical program. According to InvestingPro data, EWTX shares have declined over 51% in the past six months, currently trading at $12.85, though the stock’s valuation appears to be near its Fair Value.
The research firm expressed skepticism about an accelerated approval pathway for sevasemten in Becker muscular dystrophy (BMD), pointing to North Star Ambulatory Assessment (NSAA) baseline imbalances that complicate interpretation of the CANYON trial results. Stifel noted these imbalances make it difficult to view current data as significantly de-risking ahead of the GRAND-CANYON trial results expected in the fourth quarter of 2026. Despite operational challenges, the company maintains a strong financial position with a current ratio of 20.99, indicating robust liquidity to fund its clinical programs.
For Duchenne muscular dystrophy (DMD), Edgewise plans to meet with the FDA in the fourth quarter of 2025 to discuss functional trends observed in Phase 2 trials, potentially setting up a pivotal trial in 2026. Stifel indicated investors will likely remain skeptical as the current data remains challenging to interpret.
The research firm acknowledged sevasemten offers "upside optionality" for Edgewise shares but struggles to build strong conviction in either the BMD or DMD programs. Stifel’s analysis suggests EDG-7500 for hypertrophic cardiomyopathy (HCM) remains the most important program for the company.
Key safety questions surrounding atrial fibrillation add uncertainty to the bull case for Edgewise, according to Stifel, which believes these concerns "will take time to fully disprove." InvestingPro analysis reveals additional insights about EWTX’s financial health, with multiple ProTips and detailed metrics available for subscribers, including comprehensive analysis in the Pro Research Report covering what matters most for investors in this clinical-stage biotech company.
In other recent news, Edgewise Therapeutics reported first-quarter 2025 financial results that met analyst expectations, with a net loss of $40.8 million, or $0.43 per share. This was consistent with the consensus estimate and slightly higher than the previous quarter’s loss of $39.7 million. The company’s research and development expenses increased to $36.8 million, attributed to higher personnel costs and clinical development activities. Edgewise ended the quarter with $436.4 million in cash and bolstered its balance sheet with a $200 million stock offering in early April. The FDA deemed the data from Edgewise’s CANYON trial insufficient for accelerated approval of sevasemten for Becker muscular dystrophy, encouraging a traditional approval pathway. Despite this, Edgewise announced positive topline data from its Phase 2 Duchenne muscular dystrophy trials and plans to initiate a pivotal study in 2026. Piper Sandler reiterated its Overweight rating on Edgewise, expressing confidence in the upcoming regulatory milestones for sevasemten in Becker muscular dystrophy. RBC Capital maintained an Outperform rating, highlighting the potential of sevasemten even without accelerated approval.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.