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Bristol Myers (BMY) Gets FDA Nod for Data Addition to Camzyos
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Bristol Myers Squibb (BMY - Free Report) announced that 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 cardiac myosin inhibitor Camzyos (mavacamten, 2.5 mg, 5 mg, 10 mg, 15 mg capsules) in the United States.
Camzyos is indicated for the treatment of adults with symptomatic New York Heart Association (NYHA) class II-III obstructive hypertrophic cardiomyopathy (HCM) to improve functional capacity and symptoms.
VALOR-HCM was a randomized, double-blind, placebo-controlled, multicenter phase III study of patients with symptomatic, obstructive HCM (NYHA class II-IV) who met the guideline criteria for septal reduction therapy (SRT; LVOT gradient of ≥ 50 mmHg and NYHA class III-IV, or class II with exertional syncope or near syncope) and had been referred or were under active consideration (within the past 12 months) for an invasive procedure.
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 prior to or at week 16.
Last year, the FDA approved Camzyos based on results from the late-stage EXPLORER-HCM trial for the treatment of adults with symptomatic NYHA class II-III obstructive HCM to improve functional capacity and symptoms.
The full prescribing information for Camzyos includes a boxed warning for the risk of heart failure.
Bristol Myers shares have lost 9.5% in the year so far compared with the industry's decline of 6%.
Image Source: Zacks Investment Research
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.
While sales of the immuno-oncology drug Opdivo, approved for multiple cancer indications, maintain momentum, one of the other top drugs, Eliquis, is also now facing generic erosion in Canada and the U.K.; hence, sales of the drug declined in international markets in the first quarter.
As a result, BMY is now focused on expanding its diversified portfolio.
The company’s psoriasis drug Sotyktu (deucravacitinib) recently got approved by the European Commission (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 (NSCLC).
The FDA also granted Fast Track Designation to pipeline candidate milvexian. The candidate is being studied for the prevention and treatment of major thrombotic conditions as part of the Librexia program in collaboration with Janssen Pharmaceuticals, Inc.
While the label expansion of these drugs and the potential approval of new drugs will add an incremental revenue stream to boost growth in the coming quarters, it remains to be seen how the top line progresses.
Bristol-Myers currently carries a Zacks Rank #3 (Hold).
Over the past 30 days, earnings estimates for LGND have increased by 46 cents per share 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 $6.72 from $6.57 for 2023. Novartis surpassed estimates in all the trailing four quarters, the average surprise being 5.15%.
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Bristol Myers (BMY) Gets FDA Nod for Data Addition to Camzyos
Bristol Myers Squibb (BMY - Free Report) announced that 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 cardiac myosin inhibitor Camzyos (mavacamten, 2.5 mg, 5 mg, 10 mg, 15 mg capsules) in the United States.
Camzyos is indicated for the treatment of adults with symptomatic New York Heart Association (NYHA) class II-III obstructive hypertrophic cardiomyopathy (HCM) to improve functional capacity and symptoms.
VALOR-HCM was a randomized, double-blind, placebo-controlled, multicenter phase III study of patients with symptomatic, obstructive HCM (NYHA class II-IV) who met the guideline criteria for septal reduction therapy (SRT; LVOT gradient of ≥ 50 mmHg and NYHA class III-IV, or class II with exertional syncope or near syncope) and had been referred or were under active consideration (within the past 12 months) for an invasive procedure.
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 prior to or at week 16.
Last year, the FDA approved Camzyos based on results from the late-stage EXPLORER-HCM trial for the treatment of adults with symptomatic NYHA class II-III obstructive HCM to improve functional capacity and symptoms.
The full prescribing information for Camzyos includes a boxed warning for the risk of heart failure.
Bristol Myers shares have lost 9.5% in the year so far compared with the industry's decline of 6%.
Image Source: Zacks Investment Research
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.
While sales of the immuno-oncology drug Opdivo, approved for multiple cancer indications, maintain momentum, one of the other top drugs, Eliquis, is also now facing generic erosion in Canada and the U.K.; hence, sales of the drug declined in international markets in the first quarter.
As a result, BMY is now focused on expanding its diversified portfolio.
The company’s psoriasis drug Sotyktu (deucravacitinib) recently got approved by the European Commission (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 (NSCLC).
The FDA also granted Fast Track Designation to pipeline candidate milvexian. The candidate is being studied for the prevention and treatment of major thrombotic conditions as part of the Librexia program in collaboration with Janssen Pharmaceuticals, Inc.
While the label expansion of these drugs and the potential approval of new drugs will add an incremental revenue stream to boost growth in the coming quarters, it remains to be seen how the top line progresses.
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 46 cents per share 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 $6.72 from $6.57 for 2023. Novartis surpassed estimates in all the trailing four quarters, the average surprise being 5.15%.