Bristol Myers Squibb ( BMY Quick Quote BMY - Free Report) announced a new analysis of data from the phase III EXPLORER-HCM study on pipeline candidate, mavacamten, at the American College of Cardiology’s 70th Annual Scientific Session (ACC.21).
Mavacamten is a potential first-in-class cardiac myosin inhibitor for patients with symptomatic obstructive hypertrophic cardiomyopathy (oHCM).
The EXPLORER-HCM phase III study enrolled a total of 251 patients with symptomatic (NYHA Class II or III) oHCM. All participants had measurable left ventricular outflow tract (LVOT) gradient (resting and/or provoked) ≥50 mmHg at baseline. Patients were randomized 1:1 to receive mavacamten (n=123) or placebo (n=128) for 30 weeks, followed by an 8-week washout.
Data showed that, at 30 weeks, the change in Kansas City Cardiomyopathy Questionnaire Overall Summary Score (KCCQ OSS) was greater in the mavacamten arm as compared to the placebo arm, with similar benefits across all KCCQ subscales. Further, a larger proportion of mavacamten patients (36%) achieved greater and clinically meaningful improvement in the KCCQ OSS, compared to placebo (15%). A change of at least 5 points is required to be considered clinically significant.
We remind investors that the FDA accepted the NDA for mavacamten for patients with symptomatic oHCM in March 2021, with an assigned PDUFA goal date of Jan 28, 2022.
The candidate was added to Bristol Myers’ portfolio with the acquisition of MyoKardia in 2020. The successful development of the candidate will boost its cardiovascular franchise.
Bristol-Myers’ shares have gained 4.6% year to date against the
industry's decline of 6.2%.
The company’s performance in the first quarter of 2021 was dismal as Opdivo sales declined. Moreover, Revlimid sales weren’t impressive either.
Nevertheless, the approval of new drugs adds a new stream of revenues, which should propel growth in the coming quarters.
In March, the company and partner
bluebird bio, Inc. ( BLUE Quick Quote BLUE - Free Report) obtained the FDA approval for Abecma (idecabtagene vicleucel; ide-cel) as the first B-cell maturation antigen (BCMA)-directed chimeric antigen receptor (CAR) T cell immunotherapy for the treatment of adult patients with relapsed or refractory MM. The FDA also approved Breyanzi (lisocabtagene maraleucel: liso-cel), a CD19-directed CAR T cell therapy for the treatment of adult patients with relapsed or refractory (R/R) large B-cell lymphoma (LBCL) after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL).
The European Commission (EC) has approved Opdivo in combination with
Exelixis’ ( EXEL Quick Quote EXEL - Free Report) Cabometyx (cabozantinib) for the first-line treatment of adults with advanced renal cell carcinoma.
Bristol-Myers currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the health care sector includes
Repligen Corporation ( RGEN Quick Quote RGEN - Free Report) , which carries a Zacks Rank #2 (Buy). You can see . the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here
Earnings estimates for Repligen for 2021 moved up 4 cents in the past 60 days.
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