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Bristol Myers' (BMY) Opdivo Gets EC Nod for Label Expansion
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Bristol Myers Squibb (BMY - Free Report) announced that the European Commission (EC) approved a label expansion of the immuno-oncology drug Opdivo (nivolumab).
The EC approved the drug as a monotherapy for the adjuvant treatment of adults and adolescents 12 years of age and older with stage IIB or IIC melanoma who have undergone complete resection.
The approval in the EU was based upon results from the CheckMate -76K trial in patients with stage IIB or IIC melanoma, in which Opdivo reduced the risk of recurrence or death by 58% versus placebo.
This approval builds upon the approval of the drug in 2018 based on results from the CheckMate -238 trial.
Consequently, Opdivo is now the only PD-1 inhibitor that is indicated as an adjuvant treatment within stages IIB, IIC, III and IV of resected melanoma.
Per BMY, patients with stage IIB or IIC melanoma are at a high risk of disease recurrence following surgery; hence, this approval reinforces the benefit Opdivo may offer when used after resection, potentially preventing the disease from recurring.
CheckMate -76K study evaluates the use of Opdivo and Opdivo-based combinations in earlier stages of cancer.
Melanoma is a form of skin cancer characterized by the uncontrolled growth of pigment-producing cells (melanocytes) in the skin.
Opdivo is one of the top revenue generators for BMY and is approved for various oncology indications. The continued label expansion of the drug for additional indications should further boost its growth potential. Label expansion of Opdivo boosted sales in the second quarter of 2023, driven by higher demand for Opdivo+Yervoy combinations for non-small cell lung cancer, various gastric cancers and adjuvant bladder cancer.
Bristol Myers shares have lost 13.8% in the year so far compared with the industry's decline of 13%.
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 Revlimid and Eliquis (in Canada and the U.K.) face generic competition.
The recent approval of drugs like Opdualag, Reblozyl, Breyanzi and Sotyktu adds a new stream of revenues.
Last month, BMY reported weaker-than-expected second-quarter results due to continued generic competition for Revlimid. Generic competition for Eliquis is a headwind. The company also lowered its annual forecast.
Zacks Rank and Stocks to Consider
Bristol Myers currently carries a Zacks Rank #3 (Hold).
The loss per share estimate for SPRO for 2023 has narrowed by 49 cents to 51 cents in the past 30 days. Spero’s earnings beat estimates in all of the trailing four quarters, the average surprise being 72.43%.
The loss per share estimate for DVAX has narrowed by 27 cents to 24 cents for 2023 in the past 30 days. Dynavax has risen 41.7% in the year-to-date period. DVAX’s earnings beat estimates in two of the trailing four quarters and missed in the remaining two, the average surprise being 25.78%.
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Bristol Myers' (BMY) Opdivo Gets EC Nod for Label Expansion
Bristol Myers Squibb (BMY - Free Report) announced that the European Commission (EC) approved a label expansion of the immuno-oncology drug Opdivo (nivolumab).
The EC approved the drug as a monotherapy for the adjuvant treatment of adults and adolescents 12 years of age and older with stage IIB or IIC melanoma who have undergone complete resection.
The approval in the EU was based upon results from the CheckMate -76K trial in patients with stage IIB or IIC melanoma, in which Opdivo reduced the risk of recurrence or death by 58% versus placebo.
This approval builds upon the approval of the drug in 2018 based on results from the CheckMate -238 trial.
Consequently, Opdivo is now the only PD-1 inhibitor that is indicated as an adjuvant treatment within stages IIB, IIC, III and IV of resected melanoma.
Per BMY, patients with stage IIB or IIC melanoma are at a high risk of disease recurrence following surgery; hence, this approval reinforces the benefit Opdivo may offer when used after resection, potentially preventing the disease from recurring.
CheckMate -76K study evaluates the use of Opdivo and Opdivo-based combinations in earlier stages of cancer.
Melanoma is a form of skin cancer characterized by the uncontrolled growth of pigment-producing cells (melanocytes) in the skin.
Opdivo is one of the top revenue generators for BMY and is approved for various oncology indications. The continued label expansion of the drug for additional indications should further boost its growth potential. Label expansion of Opdivo boosted sales in the second quarter of 2023, driven by higher demand for Opdivo+Yervoy combinations for non-small cell lung cancer, various gastric cancers and adjuvant bladder cancer.
Bristol Myers shares have lost 13.8% in the year so far compared with the industry's decline of 13%.
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 Revlimid and Eliquis (in Canada and the U.K.) face generic competition.
The recent approval of drugs like Opdualag, Reblozyl, Breyanzi and Sotyktu adds a new stream of revenues.
Last month, BMY reported weaker-than-expected second-quarter results due to continued generic competition for Revlimid. Generic competition for Eliquis is a headwind. The company also lowered its annual forecast.
Zacks Rank and Stocks to Consider
Bristol Myers currently carries a Zacks Rank #3 (Hold).
A couple of better-ranked stocks in the biotech sector are Spero Therapeutics (SPRO - Free Report) and Dynavax Technologies (DVAX - Free Report) , each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
The loss per share estimate for SPRO for 2023 has narrowed by 49 cents to 51 cents in the past 30 days. Spero’s earnings beat estimates in all of the trailing four quarters, the average surprise being 72.43%.
The loss per share estimate for DVAX has narrowed by 27 cents to 24 cents for 2023 in the past 30 days. Dynavax has risen 41.7% in the year-to-date period. DVAX’s earnings beat estimates in two of the trailing four quarters and missed in the remaining two, the average surprise being 25.78%.