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Bristol Myers' (BMY) Cardiovascular Drug Review Extended by FDA
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Bristol Myers Squibb (BMY - Free Report) recently announced that the FDA has extended the review of the new drug application (NDA) for cardiovascular candidate mavacamten.
Mavacamten is being evaluated for the treatment of patients with symptomatic obstructive hypertrophic cardiomyopathy (oHCM), the most common inherited heart disease. The regulatory body was initially slated to give a decision on Jan 28, 2022. However, it notified the company that the target action date has been extended to Apr 28, 2022.
The agency requires additional time to review information pertaining to updates to the proposed Risk Evaluation Mitigation Strategy (REMS). We note that a REMS program was included in the initial application for mavacamten.
While the delay in a tentative approval was disappointing, on a positive note, the FDA did not ask for additional data or studies to be conducted.
The NDA was based on the results of phase III EXPLORER-HCM trial, which evaluated mavacamten in patients with symptomatic oHCM compared to placebo. The study results showed that all primary and secondary endpoints were met with statistical significance.
The candidate was added to Bristol Myers’ portfolio through the acquisition of erstwhile MyoKardia in 2020 for $13.1 billion.
Shares of the company have lost 6.7% year to date compared with the industry's decline of 15.8%.
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Bristol-Myers is looking to counter the generic threat to its key drugs through new drug approvals and diversification of the top line.
Earlier in the year, Bristol Myers also obtained FDA approval for 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).
The company also won FDA approval for Abecma, a first-in-class B-cell maturation antigen (BCMA)-directed CAR T cell immunotherapy.
Bristol-Myers’ performance in the third quarter of 2021 was encouraging as key drugs, Revlimid and Eliquis, maintained momentum for the company. Immuno-oncology drug Opdivo’s sales were also up after a slowdown in the first quarter.
However, competition is stiff for Opdivo from the likes of Merck’s (MRK - Free Report) Keytruda. Keytruda, approved for various oncology indications, is the key growth driver for Merck.
The FDA recently approved Keytruda for the adjuvant treatment of patients with renal cell carcinoma (RCC) at intermediate-high or high risk of recurrence, following nephrectomy, or following nephrectomy and resection of metastatic lesions. Further label expansion of the drug will boost Merck’s top line.
Loss per share estimates for Sarepta have narrowed from $6.95 to $4.99 for 2021 and from $4.83 to $3.61 for 2022 in the past 30 days. Sarepta delivered an earnings surprise of 11.06%, on average, in the last four quarters.
Loss per share estimates for Viking Therapeutics have narrowed to 74 cents from 81 cents for 2021 and to $1.08 from $1.18 for 2022 in the past 30 days. Viking delivered an earnings surprise of 2.06%, on average, in the last four quarters.
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Bristol Myers' (BMY) Cardiovascular Drug Review Extended by FDA
Bristol Myers Squibb (BMY - Free Report) recently announced that the FDA has extended the review of the new drug application (NDA) for cardiovascular candidate mavacamten.
Mavacamten is being evaluated for the treatment of patients with symptomatic obstructive hypertrophic cardiomyopathy (oHCM), the most common inherited heart disease. The regulatory body was initially slated to give a decision on Jan 28, 2022. However, it notified the company that the target action date has been extended to Apr 28, 2022.
The agency requires additional time to review information pertaining to updates to the proposed Risk Evaluation Mitigation Strategy (REMS). We note that a REMS program was included in the initial application for mavacamten.
While the delay in a tentative approval was disappointing, on a positive note, the FDA did not ask for additional data or studies to be conducted.
The NDA was based on the results of phase III EXPLORER-HCM trial, which evaluated mavacamten in patients with symptomatic oHCM compared to placebo. The study results showed that all primary and secondary endpoints were met with statistical significance.
The candidate was added to Bristol Myers’ portfolio through the acquisition of erstwhile MyoKardia in 2020 for $13.1 billion.
Shares of the company have lost 6.7% year to date compared with the industry's decline of 15.8%.
Bristol-Myers is looking to counter the generic threat to its key drugs through new drug approvals and diversification of the top line.
Earlier in the year, Bristol Myers also obtained FDA approval for 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).
The company also won FDA approval for Abecma, a first-in-class B-cell maturation antigen (BCMA)-directed CAR T cell immunotherapy.
Bristol-Myers’ performance in the third quarter of 2021 was encouraging as key drugs, Revlimid and Eliquis, maintained momentum for the company. Immuno-oncology drug Opdivo’s sales were also up after a slowdown in the first quarter.
However, competition is stiff for Opdivo from the likes of Merck’s (MRK - Free Report) Keytruda. Keytruda, approved for various oncology indications, is the key growth driver for Merck.
The FDA recently approved Keytruda for the adjuvant treatment of patients with renal cell carcinoma (RCC) at intermediate-high or high risk of recurrence, following nephrectomy, or following nephrectomy and resection of metastatic lesions. Further label expansion of the drug will boost Merck’s top line.
Zacks Rank and Other Stocks to Consider
Bristol Myers currently carries a Zacks Rank #3 (Hold). A couple of better-ranked stocks in the biotech sector are Sarepta Therapeutics (SRPT - Free Report) and Viking Therapeutics (VKTX - Free Report) , both carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Loss per share estimates for Sarepta have narrowed from $6.95 to $4.99 for 2021 and from $4.83 to $3.61 for 2022 in the past 30 days. Sarepta delivered an earnings surprise of 11.06%, on average, in the last four quarters.
Loss per share estimates for Viking Therapeutics have narrowed to 74 cents from 81 cents for 2021 and to $1.08 from $1.18 for 2022 in the past 30 days. Viking delivered an earnings surprise of 2.06%, on average, in the last four quarters.