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Bristol Myers (BMY) Heart Drug Camzyos Wins EC Approval
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Bristol Myers Squibb (BMY - Free Report) announced that the European Commission has approved Camzyos (mavacamten, 2.5 mg, 5 mg, 10 mg, 15 mg capsules) for the treatment of symptomatic (New York Heart Association, NYHA, class II-III) obstructive hypertrophic cardiomyopathy (HCM) in adult patients.
The approval was based on positive efficacy and safety results from two phase III studies, EXPLORER-HCM and VALOR-HCM. Both studies met all their primary and secondary endpoints and Camzyos demonstrated efficacy across all primary and secondary endpoints, including improvements in exercise capacity and symptom burden for these patients.
The approval makes Camzyos the first and only cardiac myosin inhibitor approved in the European Union (EU).
Symptomatic obstructive HCM, an often-inherited heart disease, can be a chronic, debilitating and progressive condition where patients may experience symptoms of shortness of breath, dizziness and fatigue as well as serious, life-altering complications, including heart failure, arrhythmias, stroke and sudden cardiac death in rare cases.
In April 2023, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended approval of Camzyos for the same.
Please note that the drug is already approved in the United States for the treatment of adults with symptomatic NYHA class II-III HCM to improve functional capacity and symptoms. It has also received regulatory approvals in various other countries.
Earlier in the month, the FDA approved the supplemental new drug application (sNDA) to add positive data from the late-stage VALOR-HCM study to the prescribing information for Camzyos in the United States.
Data added to the label showed that treatment with Camzyos significantly reduced the composite endpoint of guideline-based eligibility for septal reduction therapy (SRT) at week 16 or the decision to proceed with SRT before or at week 16.
Bristol Myers shares have lost 10% in the year so far compared with the industry's decline of 9.1%.
Image Source: Zacks Investment Research
The approval of new drugs and label expansion of existing ones will enable Bristol Myers to diversify its product base and offset the slowdown in top-line growth as one of its prime drugs, Revlimid, is facing generic competition.
BMY is now focused on expanding its diversified portfolio.
The company’s psoriasis drug Sotyktu (deucravacitinib) recently got approved by the EC. Sotyktu is a first-in-class, selective tyrosine kinase 2 (TYK2) inhibitor for treating adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy, representing a new way of treating this chronic immune-mediated disease. It is already approved in the United States.
Last month, the FDA also accepted the new drug application (NDA) for repotrectinib. The NDA is seeking approval for this next-generation tyrosine kinase inhibitor (TKI) for treating patients with ROS1-positive locally advanced or metastatic non-small cell lung cancer.
Though top-line progress is yet to be seen, the label expansion of these drugs and the potential approval of new drugs are expected to add an incremental revenue stream in the coming quarters.
Zacks Rank and Stocks to Consider
Bristol-Myers currently carries a Zacks Rank #3 (Hold).
Over the past 30 days, earnings estimates for LGND have increased by $1.09 to $5.25. LGND topped earnings estimates in two of the last four quarters and missed in the remaining two, the average surprise being 21.50%.
Over the past 60 days, NVS’ earnings estimates have increased to $6.74 from $6.60 for 2023. Novartis surpassed estimates in all the trailing four quarters, the average surprise being 5.15%.
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Bristol Myers (BMY) Heart Drug Camzyos Wins EC Approval
Bristol Myers Squibb (BMY - Free Report) announced that the European Commission has approved Camzyos (mavacamten, 2.5 mg, 5 mg, 10 mg, 15 mg capsules) for the treatment of symptomatic (New York Heart Association, NYHA, class II-III) obstructive hypertrophic cardiomyopathy (HCM) in adult patients.
The approval was based on positive efficacy and safety results from two phase III studies, EXPLORER-HCM and VALOR-HCM. Both studies met all their primary and secondary endpoints and Camzyos demonstrated efficacy across all primary and secondary endpoints, including improvements in exercise capacity and symptom burden for these patients.
The approval makes Camzyos the first and only cardiac myosin inhibitor approved in the European Union (EU).
Symptomatic obstructive HCM, an often-inherited heart disease, can be a chronic, debilitating and progressive condition where patients may experience symptoms of shortness of breath, dizziness and fatigue as well as serious, life-altering complications, including heart failure, arrhythmias, stroke and sudden cardiac death in rare cases.
In April 2023, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended approval of Camzyos for the same.
Please note that the drug is already approved in the United States for the treatment of adults with symptomatic NYHA class II-III HCM to improve functional capacity and symptoms. It has also received regulatory approvals in various other countries.
Earlier in the month, the FDA approved the supplemental new drug application (sNDA) to add positive data from the late-stage VALOR-HCM study to the prescribing information for Camzyos in the United States.
Data added to the label showed that treatment with Camzyos significantly reduced the composite endpoint of guideline-based eligibility for septal reduction therapy (SRT) at week 16 or the decision to proceed with SRT before or at week 16.
Bristol Myers shares have lost 10% in the year so far compared with the industry's decline of 9.1%.
Image Source: Zacks Investment Research
The approval of new drugs and label expansion of existing ones will enable Bristol Myers to diversify its product base and offset the slowdown in top-line growth as one of its prime drugs, Revlimid, is facing generic competition.
BMY is now focused on expanding its diversified portfolio.
The company’s psoriasis drug Sotyktu (deucravacitinib) recently got approved by the EC. Sotyktu is a first-in-class, selective tyrosine kinase 2 (TYK2) inhibitor for treating adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy, representing a new way of treating this chronic immune-mediated disease. It is already approved in the United States.
Last month, the FDA also accepted the new drug application (NDA) for repotrectinib. The NDA is seeking approval for this next-generation tyrosine kinase inhibitor (TKI) for treating patients with ROS1-positive locally advanced or metastatic non-small cell lung cancer.
Though top-line progress is yet to be seen, the label expansion of these drugs and the potential approval of new drugs are expected to add an incremental revenue stream in the coming quarters.
Zacks Rank and Stocks to Consider
Bristol-Myers currently carries a Zacks Rank #3 (Hold).
Some top-ranked stocks in the healthcare sector are Ligand Pharmaceuticals (LGND - Free Report) and Novartis (NVS - Free Report) . While LGND currently sports a Zacks Rank #1 (Strong Buy), Novartis carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Over the past 30 days, earnings estimates for LGND have increased by $1.09 to $5.25. LGND topped earnings estimates in two of the last four quarters and missed in the remaining two, the average surprise being 21.50%.
Over the past 60 days, NVS’ earnings estimates have increased to $6.74 from $6.60 for 2023. Novartis surpassed estimates in all the trailing four quarters, the average surprise being 5.15%.