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STAT+: Cytokinetics details trial win for what could be its next approval
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关键摘要
It took Cytokinetics 27 years to win its first regulatory approval.The second one could happen much faster than that.…
- The biotech on Friday unveiled the full pivotal study data of its drug…
- While some experts have described the benefits as limited, Cytokinetic…
- If approved, it would be the first treatment specifically cleared for …
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正文提要
It took Cytokinetics 27 years to win its first regulatory approval. The second one could happen much faster than that.
The biotech on Friday unveiled the full pivotal study data of its drug aficamten in an inherited heart condition called non-obstructive hypertrophic cardiomyopathy, showing that the medicine improved how patients felt and their exercise capacity.
While some experts have described the benefits as limited, Cytokinetics plans to submit the drug to the Food and Drug Administration by the end of the year. If approved, it would be the first treatment specifically cleared for what’s known as nHCM.