Bristol Myers Squibb (BMY) - Get Bristol-Myers Squibb Company Report shares fell Friday after the pharmaceutical titan said the FDA has extended its review of heart drug mavacamten for three months, until April 28.
The drug treats symptomatic obstructive hypertrophic cardiomyopathy (oHCM).
The Food and Drug Administration notified Bristol Thursday of the extension “to allow sufficient time to review information pertaining to updates to the proposed Risk Evaluation Mitigation Strategy (REMS),” the company said.
“A REMS program was included in the initial application for mavacamten. No additional data or studies have been requested.”
Bristol Myers recently traded at $58.07, down 1.6%. It has slid 14% over the past three months.
“We are confident in the profile of mavacamten,” said Samit Hirawat, chief medical officer, global drug development at Bristol Myers.
“This first-in-class cardiac myosin inhibitor demonstrated clinically meaningful improvements in symptoms, functional status, and quality of life in symptomatic oHCM patients in the pivotal EXPLORER-HCM trial.”
Mavacamten represented the top potential drug of MyoKardia, which Bristol Myers acquired last year for $13.1 billion, MarketWatch reports.
Morningstar analyst Damien Conover puts fair value for Bristol Myers at $68.
“Bristol Myers hosted an investor day highlighting a strong pipeline that holds the potential to offset the firm’s major patent losses over the next decade, a key element supporting our wide moat rating,” he wrote in a commentary Tuesday.
“With most of the updates focused on still risky early-stage pipeline assets, the updates didn’t move our fair value estimate. However, we continue to view the stock as undervalued with the market not fully appreciating the firm’s late-stage pipeline.”