Cytokinetics FDA Approval: First Heart Drug Greenlit

Adam Feuerstein is a senior writer and biotech columnist, reporting on the crossroads of drug development, business, Wall Street, and biotechnology. He is also a co-host of the weekly biotech podcast The Readout Loud and author of the newsletter Adam’s Biotech Scorecard. You can reach Adam on Signal at stataf.54.

It took 27 years, but Cytokinetics secured its first U.S. drug approval.

On Friday, the Food and Drug Administration cleared the new medicine, called Myqorzo, to treat patients with obstructive hypertrophic cardiomyopathy, an inherited heart disorder.

Cytokinetics said it will begin selling Myqorzo in late January at a price not yet disclosed. It will compete against a similar drug from Bristol Myers Squibb that was approved in 2022 and is now bringing in more than $1 billion in sales on an annualized basis, and growing.

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