Bristol-Myers Squibb Company
BMY
announced that the FDA has accepted its new drug application (“NDA”) for investigational therapy, mavacamten, which is being developed for the treatment of patients with symptomatic obstructive hypertrophic cardiomyopathy (oHCM). The regulatory body has set an action date of Jan 28, 2022.
The NDA was based on data from the pivotal phase III EXPLORER-HCM study, which evaluated mavacamten in patients with symptomatic oHCM as compared to placebo.
In the study, mavacamten demonstrated a robust treatment effect with clinically meaningful improvements in symptoms, functional status and quality of life in the given patient population. Also, mavacamten showed the ability to relieve left ventricular outflow tract obstruction in the same.
Importantly, the EXPLORER-HCM study met all the primary and secondary endpoints with statistical significance.
Shares of Bristol Myers have risen 1.1% so far this year compared with the
industry’s
increase of 2.8%.
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Please note that mavacamten is a novel, oral, allosteric modulator of cardiac myosin, which is being developed for the treatment of conditions in which excessive cardiac contractility and impaired diastolic filling of the heart are the underlying causes.
We remind investors that in November 2020, Bristol Myers acquired clinical-stage biopharmaceutical company, MyoKardia, for a total value of $13.1 billion.
With this acquisition, Bristol Myers added MyoKardia’s lead therapeutic candidate, mavacamten, to its portfolio. The deal strengthened Bristol Myers’ cardiovascular franchise as MyoKardia develops targeted therapies for the treatment of serious cardiovascular diseases.
Bristol Myers is highly active on the deal-signing/acquisition front. The company is looking to counter generic threats to its key drugs through deals and acquisitions, and introducing new products to augment its product portfolio. Such deals would help the company diversify its portfolio and drive growth in the days ahead.
Zacks Rank & Stocks to Consider
Bristol Myers currently carries a Zacks Rank #3 (Hold). Better-ranked stocks in the biotech sector include
Nabriva Therapeutics plc
NBRV
,
Repligen Corporation
RGEN
and
CytomX Therapeutics, Inc.
CTMX
, all carrying a Zacks Rank #2 (Buy) at present. You can see
the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here
.
Nabriva’s loss per share estimates have narrowed 34.3% for 2021 and 44.7% for 2022 over the past 60 days.
Repligen’s earnings estimates have been revised 15.1% upward for 2021 and 9.8% for 2022 over the past 60 days.The stock has inched up 6.4% year to date.
CytomX Therapeutics’ loss per share estimates have narrowed 31.1% for 2021 and 22.8% for 2022 over the past 60 days. The stock has rallied 26.2% year to date.
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