The FDA approved Cytokinetics’ Myqorzo, the company’s first U.S. drug, for obstructive hypertrophic cardiomyopathy (oHCM). The approval closes a 27‑year effort by the biotech and establishes Myqorzo as an oral therapy option in a market where a Bristol Myers Squibb rival already has traction. Cytokinetics said it will begin selling Myqorzo in late January; the company will compete with an existing BMS product that has already reached blockbuster sales. Management emphasized the regulatory milestone as validation of its discovery and development strategy. The approval gives Cytokinetics a commercial launch and shifts the company from pure R&D to an operational phase with manufacturing, commercialization and market access priorities. Analysts flagged potential commercial upside but noted the need to execute on launch logistics and payer negotiations.
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