We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies, revised Privacy Policy and Terms of Service.
You are being directed to ZacksTrade, a division of LBMZ Securities and licensed broker-dealer. ZacksTrade and Zacks.com are separate companies. The web link between the two companies is not a solicitation or offer to invest in a particular security or type of security. ZacksTrade does not endorse or adopt any particular investment strategy, any analyst opinion/rating/report or any approach to evaluating individual securities.
If you wish to go to ZacksTrade, click OK. If you do not, click Cancel.
Bristol Myers' (BMY) Opdivo With Chemo Gets EC Nod for NSCLC
Read MoreHide Full Article
Bristol Myers Squibb (BMY - Free Report) announced that the European Commission (EC) has granted approval to Opdivo (nivolumab) for yet another indication.
Opdivo, in combination with platinum-based chemotherapy, won EC approval for the neoadjuvant treatment of resectable non-small cell lung cancer (NSCLC) at a high risk of recurrence in adult patients with tumor cell PD-L1 expression ≥1%.
This approval positions Opdivo as the first neoadjuvant immunotherapy-based treatment option available for patients in the European Union (EU) in this specific setting, opening up incremental revenue growth opportunities for BMY.
The EC's decision is based on compelling data from the phase III CheckMate -816 trial, where the addition of Opdivo with chemotherapy demonstrated significant and clinically meaningful improvements in event-free survival and pathologic complete response compared to chemotherapy alone when administered before surgery. This is a significant advancement as resectable NSCLC patients often face a risk of recurrence post-surgery, leading to adverse outcomes. With the approval of Opdivo, there is now a potential solution to address this unmet medical need and help prevent recurrences effectively.
The EC approval not only applies to patients in the 27 member states of the EU but also extends to Iceland, Liechtenstein and Norway, enhancing Opdivo's potential market reach and revenue generation in the region. Per BMY, lung cancer is the leading cause of cancer deaths globally and NSCLC is one of the most common types of lung cancer, representing up to 84% of diagnoses.
Opdivo-based options are now approved for the neoadjuvant or adjuvant treatment of four different cancer types within the EU. These include NSCLC, urothelial carcinoma, esophageal/gastroesophageal junction cancer and melanoma.
Bristol Myers shares have lost 11.2% in the year so far compared with the industry's decline of 10.2%.
Image Source: Zacks Investment Research
Opdivo's label expansion presents a significant opportunity for Bristol Myers to offset declining revenues from Revlimid, one of its key revenue-generating drugs. Revlimid, a blockbuster drug used in the treatment of multiple myeloma, is facing patent expirations and increasing competition from generic alternatives.
BMY's commitment to advancing cancer treatments is evident through its robust development program, encompassing various tumor types in earlier stages of cancer.
BMY is now focused on expanding its diversified portfolio.
Earlier in the week, the EC approved Camzyos (mavacamten, 2.5 mg, 5 mg, 10 mg, 15 mg capsules) for the treatment of symptomatic (New York Heart Association, NYHA, class II-III) obstructive hypertrophic cardiomyopathy (HCM) in adult patients. Please note that the drug is already approved in the United States for the treatment of adults with symptomatic NYHA class II-III HCM to improve functional capacity and symptoms. It has also received regulatory approvals in various other countries.
The company’s psoriasis drug Sotyktu (deucravacitinib) was recently approved by the 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.
Merck’s (MRK - Free Report) Keytruda is one of the leading immunotherapy drugs in the NSCLC market. It has shown remarkable efficacy in various settings, including as a monotherapy and in combination with chemotherapy.
Keytruda has secured approvals for both first-line and second-line treatments in NSCLC, making it a formidable competitor to Opdivo. Merck continues to work on expanding Keytruda’s label further.
Zacks Rank and Stocks to Consider
Bristol-Myers currently carries a Zacks Rank #3 (Hold).
Over the past 30 days, earnings estimates for LGND have increased by $1.09 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, earnings estimates for NVS have increased to $6.74 from $6.60 for 2023. Novartis surpassed estimates in all the trailing four quarters, the average surprise being 5.15%.
Disclaimer: This article has been written with the assistance of Generative AI. However, the author has reviewed, revised, supplemented, and rewritten parts of this content to ensure its originality and the precision of the incorporated information.
See More Zacks Research for These Tickers
Normally $25 each - click below to receive one report FREE:
Image: Shutterstock
Bristol Myers' (BMY) Opdivo With Chemo Gets EC Nod for NSCLC
Bristol Myers Squibb (BMY - Free Report) announced that the European Commission (EC) has granted approval to Opdivo (nivolumab) for yet another indication.
Opdivo, in combination with platinum-based chemotherapy, won EC approval for the neoadjuvant treatment of resectable non-small cell lung cancer (NSCLC) at a high risk of recurrence in adult patients with tumor cell PD-L1 expression ≥1%.
This approval positions Opdivo as the first neoadjuvant immunotherapy-based treatment option available for patients in the European Union (EU) in this specific setting, opening up incremental revenue growth opportunities for BMY.
The EC's decision is based on compelling data from the phase III CheckMate -816 trial, where the addition of Opdivo with chemotherapy demonstrated significant and clinically meaningful improvements in event-free survival and pathologic complete response compared to chemotherapy alone when administered before surgery. This is a significant advancement as resectable NSCLC patients often face a risk of recurrence post-surgery, leading to adverse outcomes. With the approval of Opdivo, there is now a potential solution to address this unmet medical need and help prevent recurrences effectively.
The EC approval not only applies to patients in the 27 member states of the EU but also extends to Iceland, Liechtenstein and Norway, enhancing Opdivo's potential market reach and revenue generation in the region. Per BMY, lung cancer is the leading cause of cancer deaths globally and NSCLC is one of the most common types of lung cancer, representing up to 84% of diagnoses.
Opdivo-based options are now approved for the neoadjuvant or adjuvant treatment of four different cancer types within the EU. These include NSCLC, urothelial carcinoma, esophageal/gastroesophageal junction cancer and melanoma.
Bristol Myers shares have lost 11.2% in the year so far compared with the industry's decline of 10.2%.
Image Source: Zacks Investment Research
Opdivo's label expansion presents a significant opportunity for Bristol Myers to offset declining revenues from Revlimid, one of its key revenue-generating drugs. Revlimid, a blockbuster drug used in the treatment of multiple myeloma, is facing patent expirations and increasing competition from generic alternatives.
BMY's commitment to advancing cancer treatments is evident through its robust development program, encompassing various tumor types in earlier stages of cancer.
BMY is now focused on expanding its diversified portfolio.
Earlier in the week, the EC approved Camzyos (mavacamten, 2.5 mg, 5 mg, 10 mg, 15 mg capsules) for the treatment of symptomatic (New York Heart Association, NYHA, class II-III) obstructive hypertrophic cardiomyopathy (HCM) in adult patients. Please note that the drug is already approved in the United States for the treatment of adults with symptomatic NYHA class II-III HCM to improve functional capacity and symptoms. It has also received regulatory approvals in various other countries.
The company’s psoriasis drug Sotyktu (deucravacitinib) was recently approved by the 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.
Merck’s (MRK - Free Report) Keytruda is one of the leading immunotherapy drugs in the NSCLC market. It has shown remarkable efficacy in various settings, including as a monotherapy and in combination with chemotherapy.
Keytruda has secured approvals for both first-line and second-line treatments in NSCLC, making it a formidable competitor to Opdivo. Merck continues to work on expanding Keytruda’s label further.
Zacks Rank and Stocks to Consider
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 $1.09 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, earnings estimates for NVS have increased to $6.74 from $6.60 for 2023. Novartis surpassed estimates in all the trailing four quarters, the average surprise being 5.15%.
Disclaimer: This article has been written with the assistance of Generative AI. However, the author has reviewed, revised, supplemented, and rewritten parts of this content to ensure its originality and the precision of the incorporated information.