Cytokinetics drug Myqorzo won FDA approval for treating obstructive hypertrophic cardiomyopathy, or oHCM. Compared to Bristol Myers Squibb’s projected blockbuster drug Camzyos, the Cytokinetics daily pill has less restrictive safety and monitoring requirements, giving it a competitive advantage, according to analysts.
The FDA asked Cytokinetics for the Risk Evaluation and Mitigation Strategy after it had already accepted the application for aficamten, a potential competitor to Bristol Myers Squibbs heart drug Camzyos. Analysts say this development could signal a change in FDA thinking about risk management for the broader drug class.
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Cytokinetics drug aficamten met the main goal of a pivotal test in obstructive hypertrophic cardiomyopathy. If approved, the daily pill would compete against a Bristol Myers Squibb drug projected to become a blockbuster seller.
Cytokinetics drug reldesemtiv has failed a pivotal clinical trial in amyotrophic lateral sclerosis. The small molecule had previously failed in Phase 2, but the biotech believed adjustments could lead to better results in Phase 3.
A Cytokinetics drug in development for treating a rare heart disorder has promising Phase 2 data suggesting it could compete against a Bristol Myers Squibb drug currently under FDA review. Cytokinetics plans to advance its small molecule to Phase 3 testing by the end of this year.
Despite the trial not showing statistical significance on the primary or secondary efficacy endpoints, the company views the data as supportive of reldesemtiv's Phase III development
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