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Edgewise Therapeutics Stock Plummets on Drug Trial 'Adverse Events'


Key Takeaways



Edgewise Therapeutics ( EWTX ) shares tumbled more than 20% Wednesday after the developmental drug company issued the results of its latest clinical trial.

The company released the results of a Phase 2 trial for EDG-7500, a drug to treat Hypertrophic Cardiomyopathy (HCM), a condition that involves thickened heart muscles, which can make it more difficult for the heart to pump blood effectively.

Edgewise said the drug largely accomplished its goal of reducing left ventricular outflow tract gradient (LVOT-G)--a metric that measures how difficult it is for the heart to pump blood--"without meaningful changes in left ventricular ejection fraction (LVEF)."

Side Effects Weigh

However, the drug's side effects have overshadowed the positive results. The most common side effects were dizziness and an infection in the upper respiratory tract, along with atrial fibrillation (AF), also known as an irregular heartbeat. However, "two participants experienced serious adverse events of AF requiring cardioversion," or treatment to get a heart back to a normal rhythm.

The company said that the rate of patients who experienced AF was within the range of similar studies with other drugs. According to Investor's Business Daily , RBC Capital Markets analyst Leonid Timashev wrote in a note, "The fact that two were serious is a complexity that could prompt the FDA to review this closely."

Shares of Cytokinetics ( CYTK ), which is working on a competing drug, jumped 10% on the concerning results for Edgewise. Shares of Edgewise were down 21%.

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