FDA delay takes bite out of Bristol Myers first mover advantage

A 2% share price drop followed Bristol Myers Squibb’s (NYSE: BMY) announcement on Friday that the US regulator is not yet ready to deliver a verdict on its submission for mavacamten.

The US Foo and Drug Administration has been reviewing data on the investigational drug, a first-in-class cardiac myosin inhibitor, as an option for people with symptomatic obstructive hypertrophic cardiomyopathy (oHCM).

The new deadline for a decision is April 28, 2022, with the extension allowing time to review “information pertaining to updates to the proposed Risk Evaluation Mitigation Strategy (REMS).”