Bristol Myers Squibb Announces New PDUFA Date for Mavacamten
November 19 2021 - 6:59AM
Business Wire
Bristol Myers Squibb (NYSE: BMY) today announced that the U.S.
Food and Drug Administration (FDA) has extended the review of the
New Drug Application (NDA) for mavacamten for the treatment of
patients with symptomatic obstructive hypertrophic cardiomyopathy
(oHCM) to April 28, 2022.
The FDA notified Bristol Myers Squibb on November 18, 2021 of
the extension of the PDUFA date to allow sufficient time to review
information pertaining to updates to the proposed Risk Evaluation
Mitigation Strategy (REMS). A REMS program was included in the
initial application for mavacamten. No additional data or studies
have been requested.
“We are confident in the profile of mavacamten. 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,” said Samit Hirawat, M.D., executive vice president, chief
medical officer, global drug development, Bristol Myers Squibb. “We
look forward to continuing to work closely with the FDA to bring
this important medicine to patients.”
About Bristol Myers
Squibb
Bristol Myers Squibb is a global biopharmaceutical company whose
mission is to discover, develop and deliver innovative medicines
that help patients prevail over serious diseases. For more
information about Bristol Myers Squibb, visit us at BMS.com or
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Bristol Myers Squibb Cautionary
Statement Regarding Forward-Looking Statements
This press release contains “forward-looking statements” within
the meaning of the Private Securities Litigation Reform Act of 1995
regarding, among other things, the research, development and
commercialization of pharmaceutical products. All statements that
are not statements of historical facts are, or may be deemed to be,
forward-looking statements. Such forward-looking statements are
based on historical performance and current expectations and
projections about our future financial results, goals, plans and
objectives and involve inherent risks, assumptions and
uncertainties, including internal or external factors that could
delay, divert or change any of them in the next several years, that
are difficult to predict, may be beyond our control and could cause
our future financial results, goals, plans and objectives to differ
materially from those expressed in, or implied by, the statements.
These risks, assumptions, uncertainties and other factors include,
among others, that mavacamten may not receive regulatory approval
for the indication described in this release in the currently
anticipated timeline or at all, any marketing approvals, if
granted, may have significant limitations on their use, and, if
approved, whether such product candidate for such indication
described in this release will be commercially successful. No
forward-looking statement can be guaranteed. Forward-looking
statements in this press release should be evaluated together with
the many risks and uncertainties that affect Bristol Myers Squibb’s
business and market, particularly those identified in the
cautionary statement and risk factors discussion in Bristol Myers
Squibb’s Annual Report on Form 10-K for the year ended December 31,
2020, as updated by our subsequent Quarterly Reports on Form 10-Q,
Current Reports on Form 8-K and other filings with the Securities
and Exchange Commission. The forward-looking statements included in
this document are made only as of the date of this document and
except as otherwise required by applicable law, Bristol Myers
Squibb undertakes no obligation to publicly update or revise any
forward-looking statement, whether as a result of new information,
future events, changed circumstances or otherwise.
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Bristol Myers Squibb
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