Biotech company Edgewise Therapeutics (NASDAQ: EWTX) stock rose to a three-year high on Thursday on positive results from its clinical trial of a drug slated to treat cardiomyopathy.
The company tested its drug, EDG-7500, in both healthy healthy volunteers and patients with obstructive hypertrophic cardiomyopathy. Patients showed improve blood flow from the left venticle after the initial dose, and the market rejoiced by bumping the company’s stock by approximately 55 per cent.
Cardiomyopathy is a group of diseases that affect the heart muscle, making it harder for the heart to pump blood efficiently.
It can cause the heart to enlarge, thicken, or stiffen, leading to symptoms like shortness of breath, fatigue, and irregular heartbeats. Furthermore, the main types include dilated, hypertrophic, restrictive, and arrhythmogenic right ventricular cardiomyopathy.
Causes range from genetic factors to long-term conditions like high blood pressure and diabetes. Treatment options vary depending on the severity and type, and may involve medications, lifestyle changes, or in advanced cases, devices or heart transplants.
Additionally, EDG-7500 is a new oral medication designed to improve heart function in patients with hypertrophic cardiomyopathy (HCM) and other diastolic dysfunctions by slowing early heart contraction and aiding relaxation.
Early tests suggest it can effectively treat HCM with minimal risk to heart function. The company is running a three-part trial called CIRRUS-HCM, involving around 55 patients at 20 U.S. sites. Part A focuses on the safety and tolerability of a single dose, while Parts B and C will assess the effects of multiple doses over 28 days in patients with both obstructive and non-obstructive HCM.
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Results better than company’s own expectations
The company’s competitors haven’t fared quite so well with the news.
Shares of Cytokinetics (NASDAQ: CYTK) dropped 1.6 per cent to USD$55.03, meanwhile Bristol Myers Squibb (NYSE: BMY), which markets the only approved treatment for hypertrophic cardiomyopathy, fell 1.1 per cent to USD$49.18. Cytokinetics is also developing an experimental drug for the same condition.
Edgewise tested three doses of its drug EDG-7500 in patients with obstructive HCM. At the two higher doses, patients showed an average reduction in left ventricular outflow tract (LVOT) pressure gradient.
LVOT measures the pressure gradient between the left ventricle and the aorta, indicating how hard the heart works to pump blood and serving as a predictor of heart failure. Importantly, this reduction in LVOT pressure occurred without a significant change in left ventricular ejection fraction (LVEF), meaning the heart did not excessively suppress cardiac function.
Wedbush analyst Laura Chico noted that the results support the hypothesis that reductions in LVOT gradient can be achieved without declines in LVEF with EDG-7500.
Chico expressed optimism about the drug’s potential, stating that while repeat dosing data will provide more insight into its effectiveness and safety, the initial results are promising and likely to positively influence the stock. Chico has given Edgewise stock an outperform rating with a price target of 31.
These results exceeded Edgewise Therapeutics’ own expectations, as they had aimed for a reduction in LVOT pressure gradient of at least 50 per cent with minimal impact on LVEF.
Several analysts upgraded their price targets for Edgewise Therapeutics, reflecting optimism about the drug’s future. Truist Financial, for example, raised its target to USD$33.00, and other analysts offered similarly positive outlooks, driving the stock’s upward momentum.
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