Cytokinetics (CYTK) stock slumped Monday despite seemingly positive test results for its Bristol Myers Squibb (BMY)-rivaling treatment for a heart disease.
The company tested its drug, aficamten, in patients with obstructive hypertrophic cardiomyopathy, or HCM. In this condition, a genetic mutation causes the heart ventricles to thicken. This makes it difficult for the heart to pump blood — causing shortness of breath, chest pain and fainting during exercise.
After 24 weeks, patients who received aficamten had a significantly improved exercise capacity vs. the placebo group. Patients also showed improvements in 10 secondary goals of the study.
Cytokinetics Chief Executive Robert Blum called the results of the Sequoia study "pristine."
"The consistency and the robustness of these results, we think, are very compelling," he told Investor's Business Daily. "Having been involved in this business for a long time, I can't remember another occasion where I've been able to be associated with such a pristine data set across every one of the endpoints. That's a very rare privilege."
But in morning trades on today's stock market, Cytokinetics stock tumbled more than 5% to 58.51. Shares have mostly traded below their 50-day moving average since late February, MarketSurge shows.
Shares initially rocketed 82.5% on Dec. 27 when Cytokinetics announced the top-line results of the Sequoia study. On Jan. 8, Cytokinetics shares jumped another 15% to a record high at 110.25 on takeover rumors. But the biotech stock has since pulled back almost 44% from that point.
Aficamten works by blocking an enzyme called myosin, helping reduce excessive heart contractility. It uses the same mechanism as Bristol Myers' Camzyos. But, Blum says, aficamten could be a safer version than Camzyos.
After 24 weeks, patients who received aficamten in the Sequoia study had a seven-point improvement in symptoms on the 100-point Kansas City Cardiomyopathy Questionnaire. The questionnaire assesses a patient's quality of life. On another measurement of heart failure symptoms, 34% of aficamten recipients improved by at least one class. There are four classes of heart failure.
Further, patients who received aficamten spent 78 fewer days eligible for septal reduction therapy, or SRT. Doctors recommend SRT for patients with hypertrophic cardiomyopathy when a medicine fails to control heart-failure symptoms. The aficamten treatment group also had an 80% reduction in a biomarker of cardiac wall stress compared with the placebo group.
Cytokinetics is now planning to ask the Food and Drug Administration and the European Medicines Agency to approve aficamten in the third and fourth quarters, respectively. The company is aiming for a mid-2025 launch.
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