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BMY Gets Positive CHMP Opinion for Opdivo, Yervoy Combo and Breyanzi
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Bristol Myers Squibb (BMY - Free Report) announced that it has obtained a positive opinion from the Committee for Medicinal Products for Human Use (“CHMP”) of the European Medicines Agency for two of its drugs.
The CHMP recommended approval of Opdivo (nivolumab) plus Yervoy (ipilimumab) for the first-line treatment of adult patients with unresectable or advanced hepatocellular carcinoma (HCC).
The CHMP also recommended approval of Breyanzi (lisocabtagene maraleucel; liso-cel) for relapsed or refractory follicular lymphoma.
Shares of BMY have risen 29.8% in the past year against the industry’s decline of 8.7%.
Image Source: Zacks Investment Research
More on BMY’s Opdivo plus Yervoy Combo for HCC
The positive CHMP opinion was based on late-stage CheckMate -9DW trial, which demonstrated statistically significant and clinically meaningful improvement in overall survival with Opdivo plus Yervoy compared to investigator’s choice of lenvatinib or sorafenib in RCC patients.
HCC is the most common type of liver cancer.
The FDA also accepted the company’s supplemental biologics license application for the combination as a potential first-line treatment option for adult patients with unresectable HCC and assigned a target action date of Apr. 21, 2025.
We remind investors that the combination was granted accelerated approval by the FDA in 2020 based on results from the phase II CheckMate -040 trial and has been an established second-line treatment for patients with advanced HCC. Opdivo is approved for several oncology indications. Opdivo, in combination with Yervoy, is already indicated for metastatic non-small cell lung cancer, malignant pleural mesothelioma and other indications.
Opdivo, in combination with Exelixis’ (EXEL - Free Report) Cabometyx (cabozantinib), is almost indicated for the first-line treatment of adult patients with advanced RCC.
The label expansion of the drug in additional indications should further boost sales of the combination.
More on BMY’s Breyanzi
Breyanzi is a CD19-directed chimeric antigen receptor (CAR) T-cell therapy. The CHMP adopted a positive opinion based on data from the global, phase II TRANSCEND FL study, the largest clinical trial to date to evaluate a CAR T cell therapy in patients with relapsed or refractory indolent non-Hodgkin lymphoma (NHL), including FL, which enrolled adults with relapsed or refractory FL treated with Breyanzi after two or more prior lines of systemic therapy.
Results showed 97.1% of patients responded to Breyanzi, with 94.2% of patients achieving complete response.
We note that Breyanzi is currently approved in the EU for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), high-grade B-cell lymphoma (HGBCL), primary mediastinal large B-cell lymphoma (PMBCL) and FL grade 3B (FL3B), who relapsed within 12 months from completion of or are refractory to, first-line chemoimmunotherapy, and for the treatment of adult patients with relapsed or refractory DLBCL, PMBCL, and FL3B after two or more lines of systemic therapy.
BMY’s Efforts to Diversify Portfolio
BMY is banking on newer drugs like Opdualag, Reblozyl and Breyanzi to stabilize its revenue base. Approval of additional new drugs and label expansion of top drugs should further diversify its pipeline.
BMY recently won FDA approval for xanomeline and trospium chloride (formerly KarXT), an oral medication for the treatment of schizophrenia, in adults. The drug was approved under the brand name Cobenfy.
Cobenfy represents the first new pharmacological approach to treating schizophrenia in decades.
BMY made strategic acquisitions to augment its product portfolio, and these seem to be paying off now. However, there is a long way to go. On the other hand, the company has taken on colossal debt to finance these acquisitions.
The FDA recently approved Opdivo Qvantig (nivolumab and hyaluronidase-nvhy) injection for subcutaneous use, a combination product of nivolumab co-formulated with recombinant human hyaluronidase (rHuPH20), in most previously approved adult, solid tumor Opdivo indications as monotherapy, monotherapy maintenance following completion of Opdivo plus Yervoy combination therapy, or in combination with chemotherapy or cabozantinib.
BMY's Zacks Rank & Stocks to Consider
Bristol Myers currently carries a Zacks Rank #3 (Hold).
In the past 30 days, estimates for BioMarin Pharmaceutical’s 2024 earnings per share have improved from $3.28 to $3.29. Estimates for 2025 earnings per share have decreased from $4.05 to $4.02 during the same timeframe.
BMRN’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 28.7%.
In the past 30 days, estimates for Alnylam Pharmaceuticals’ 2024 loss per share have remained constant at 39 cents. The consensus mark for 2025 earnings per share is currently pegged at 41 cents.
ALNY’s earnings beat estimates in three of the trailing four quarters and met once, delivering an average surprise of 65.67%.
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BMY Gets Positive CHMP Opinion for Opdivo, Yervoy Combo and Breyanzi
Bristol Myers Squibb (BMY - Free Report) announced that it has obtained a positive opinion from the Committee for Medicinal Products for Human Use (“CHMP”) of the European Medicines Agency for two of its drugs.
The CHMP recommended approval of Opdivo (nivolumab) plus Yervoy (ipilimumab) for the first-line treatment of adult patients with unresectable or advanced hepatocellular carcinoma (HCC).
The CHMP also recommended approval of Breyanzi (lisocabtagene maraleucel; liso-cel) for relapsed or refractory follicular lymphoma.
Shares of BMY have risen 29.8% in the past year against the industry’s decline of 8.7%.
Image Source: Zacks Investment Research
More on BMY’s Opdivo plus Yervoy Combo for HCC
The positive CHMP opinion was based on late-stage CheckMate -9DW trial, which demonstrated statistically significant and clinically meaningful improvement in overall survival with Opdivo plus Yervoy compared to investigator’s choice of lenvatinib or sorafenib in RCC patients.
HCC is the most common type of liver cancer.
The FDA also accepted the company’s supplemental biologics license application for the combination as a potential first-line treatment option for adult patients with unresectable HCC and assigned a target action date of Apr. 21, 2025.
We remind investors that the combination was granted accelerated approval by the FDA in 2020 based on results from the phase II CheckMate -040 trial and has been an established second-line treatment for patients with advanced HCC.
Opdivo is approved for several oncology indications. Opdivo, in combination with Yervoy, is already indicated for metastatic non-small cell lung cancer, malignant pleural mesothelioma and other indications.
Opdivo, in combination with Exelixis’ (EXEL - Free Report) Cabometyx (cabozantinib), is almost indicated for the first-line treatment of adult patients with advanced RCC.
The label expansion of the drug in additional indications should further boost sales of the combination.
More on BMY’s Breyanzi
Breyanzi is a CD19-directed chimeric antigen receptor (CAR) T-cell therapy. The CHMP adopted a positive opinion based on data from the global, phase II TRANSCEND FL study, the largest clinical trial to date to evaluate a CAR T cell therapy in patients with relapsed or refractory indolent non-Hodgkin lymphoma (NHL), including FL, which enrolled adults with relapsed or refractory FL treated with Breyanzi after two or more prior lines of systemic therapy.
Results showed 97.1% of patients responded to Breyanzi, with 94.2% of patients achieving complete response.
We note that Breyanzi is currently approved in the EU for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), high-grade B-cell lymphoma (HGBCL), primary mediastinal large B-cell lymphoma (PMBCL) and FL grade 3B (FL3B), who relapsed within 12 months from completion of or are refractory to, first-line chemoimmunotherapy, and for the treatment of adult patients with relapsed or refractory DLBCL, PMBCL, and FL3B after two or more lines of systemic therapy.
BMY’s Efforts to Diversify Portfolio
BMY is banking on newer drugs like Opdualag, Reblozyl and Breyanzi to stabilize its revenue base. Approval of additional new drugs and label expansion of top drugs should further diversify its pipeline.
BMY recently won FDA approval for xanomeline and trospium chloride (formerly KarXT), an oral medication for the treatment of schizophrenia, in adults. The drug was approved under the brand name Cobenfy.
Cobenfy represents the first new pharmacological approach to treating schizophrenia in decades.
BMY made strategic acquisitions to augment its product portfolio, and these seem to be paying off now. However, there is a long way to go. On the other hand, the company has taken on colossal debt to finance these acquisitions.
The FDA recently approved Opdivo Qvantig (nivolumab and hyaluronidase-nvhy) injection for subcutaneous use, a combination product of nivolumab co-formulated with recombinant human hyaluronidase (rHuPH20), in most previously approved adult, solid tumor Opdivo indications as monotherapy, monotherapy maintenance following completion of Opdivo plus Yervoy combination therapy, or in combination with chemotherapy or cabozantinib.
BMY's Zacks Rank & Stocks to Consider
Bristol Myers currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks from the pharma/biotech sector are BioMarin Pharmaceutical (BMRN - Free Report) and Alnylam Pharmaceuticals (ALNY - Free Report) . Both sport a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 30 days, estimates for BioMarin Pharmaceutical’s 2024 earnings per share have improved from $3.28 to $3.29. Estimates for 2025 earnings per share have decreased from $4.05 to $4.02 during the same timeframe.
BMRN’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 28.7%.
In the past 30 days, estimates for Alnylam Pharmaceuticals’ 2024 loss per share have remained constant at 39 cents. The consensus mark for 2025 earnings per share is currently pegged at 41 cents.
ALNY’s earnings beat estimates in three of the trailing four quarters and met once, delivering an average surprise of 65.67%.