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Bristol Myers (BMY) Gets European Commission Nod for Inrebic
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Bristol-Myers Squibb Company (BMY - Free Report) announced that the European Commission (“EC”) has granted marketing authorization to its once-daily oral therapy Inrebic (fedratinib) for the treatment of disease-related splenomegaly or symptoms in adult patients with primary myelofibrosis, post-polycythemia vera myelofibrosis or post-essential thrombocythemia myelofibrosis, who are Janus Associated Kinase (“JAK”) inhibitor naive or have been previously treated with Incyte Corporation’s (INCY - Free Report) Jakafi (ruxolitinib).
Shares of Bristol Myers have decreased 2.9% so far this year against the industry’s increase of 11.5%.
Myelofibrosis is a serious and rare bone marrow disorder that disrupts the body’s normal production of blood cells.
The EC approval was based on data from the JAKARTA and JAKARTA2 studies. The primary endpoint of JAKARTA and JAKARTA2 was the spleen response rate, defined as the proportion of patients achieving greater than or equal to a 35% reduction from baseline in spleen volume at the end of cycle 6. Data from the same showed that treatment with Inrebic led to clinically meaningful spleen and symptom response in myelofibrosis patients where treatment with Jakafi has failed, as well as patients who are intolerant to Jakafi or who are JAK inhibitor naive.
Following the nod, Inrebic became the first new therapy to be approved for myelofibrosis in Europe in almost a decade.
We note that Inrebic is approved in the United States for the treatment of adult patients with intermediate-2 or high-risk primary or secondary myelofibrosis. Inrebic generated sales worth $55 million in 2020. The approval in EU should lead to increased sales of the drug in the days ahead.
In a separate press release, Bristol Myers announced data from new analyses from the pivotal phase III CheckMate-9ER study which evaluated the combination of Opdivo (nivolumab) and Exelixis’ (EXEL - Free Report) Cabometyx (cabozantinib) versus Pfizer’s (PFE - Free Report) Sutent (sunitinib) for the first-line treatment of advanced renal cell carcinoma.
Data from the study showed that the combo of Opdivo plus Cabometyx continues to demonstrate superior progression-free survival, overall survival and objective response rate as compared to Sutent.
Simultaneously, the company announced data from the phase III CheckMate-274 study which showed that Opdivo, as an adjuvant treatment, demonstrated statistically significant and clinically meaningful improvement in disease-free survival in patients with muscle-invasive urothelial carcinoma.
It could become the mother of all technological revolutions. Apple sold a mere 1 billion iPhones in 10 years but a new breakthrough is expected to generate more than 77 billion devices by 2025, creating a $1.3 trillion market.
Zacks has just released a Special Report that spotlights this fast-emerging phenomenon and 4 tickers for taking advantage of it. If you don't buy now, you may kick yourself in 2022.
Image: Shutterstock
Bristol Myers (BMY) Gets European Commission Nod for Inrebic
Bristol-Myers Squibb Company (BMY - Free Report) announced that the European Commission (“EC”) has granted marketing authorization to its once-daily oral therapy Inrebic (fedratinib) for the treatment of disease-related splenomegaly or symptoms in adult patients with primary myelofibrosis, post-polycythemia vera myelofibrosis or post-essential thrombocythemia myelofibrosis, who are Janus Associated Kinase (“JAK”) inhibitor naive or have been previously treated with Incyte Corporation’s (INCY - Free Report) Jakafi (ruxolitinib).
Shares of Bristol Myers have decreased 2.9% so far this year against the industry’s increase of 11.5%.
Myelofibrosis is a serious and rare bone marrow disorder that disrupts the body’s normal production of blood cells.
The EC approval was based on data from the JAKARTA and JAKARTA2 studies. The primary endpoint of JAKARTA and JAKARTA2 was the spleen response rate, defined as the proportion of patients achieving greater than or equal to a 35% reduction from baseline in spleen volume at the end of cycle 6. Data from the same showed that treatment with Inrebic led to clinically meaningful spleen and symptom response in myelofibrosis patients where treatment with Jakafi has failed, as well as patients who are intolerant to Jakafi or who are JAK inhibitor naive.
Following the nod, Inrebic became the first new therapy to be approved for myelofibrosis in Europe in almost a decade.
We note that Inrebic is approved in the United States for the treatment of adult patients with intermediate-2 or high-risk primary or secondary myelofibrosis. Inrebic generated sales worth $55 million in 2020. The approval in EU should lead to increased sales of the drug in the days ahead.
In a separate press release, Bristol Myers announced data from new analyses from the pivotal phase III CheckMate-9ER study which evaluated the combination of Opdivo (nivolumab) and Exelixis’ (EXEL - Free Report) Cabometyx (cabozantinib) versus Pfizer’s (PFE - Free Report) Sutent (sunitinib) for the first-line treatment of advanced renal cell carcinoma.
Data from the study showed that the combo of Opdivo plus Cabometyx continues to demonstrate superior progression-free survival, overall survival and objective response rate as compared to Sutent.
Simultaneously, the company announced data from the phase III CheckMate-274 study which showed that Opdivo, as an adjuvant treatment, demonstrated statistically significant and clinically meaningful improvement in disease-free survival in patients with muscle-invasive urothelial carcinoma.
Zacks Rank
Bristol Myers currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
More Stock News: This Is Bigger than the iPhone!
It could become the mother of all technological revolutions. Apple sold a mere 1 billion iPhones in 10 years but a new breakthrough is expected to generate more than 77 billion devices by 2025, creating a $1.3 trillion market.
Zacks has just released a Special Report that spotlights this fast-emerging phenomenon and 4 tickers for taking advantage of it. If you don't buy now, you may kick yourself in 2022.
Click here for the 4 trades >>