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Bristol Myers' (BMY) Opdivo Label Expansion Filings Get Accepted
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Bristol Myers (BMY - Free Report) announced the acceptance of its regulatory applications for neoadjuvant Opdivo (nivolumab) with chemotherapy followed by surgery and adjuvant Opdivo for the perioperative treatment of resectable stage IIA to IIIB non-small cell lung cancer (NSCLC) in the United States and EU.
A decision from the FDA regarding the Opdivo supplemental biologics license application is expected on Oct 8, 2024. The application seeking marketing approval for this expanded indication of Opdivo in the EU was validated by the European Medicines Agency (EMA) in late January and is currently under review.
The submissions to the FDA and EMA were based on positive results from the phase III CheckMate -77T study demonstrating statistically significant and clinically meaningful improvements in event-free survival, which is the study’s primary endpoint.
Opdivo, the company’s PD-1 immune checkpoint inhibitor, was initially approved in 2014 to intravenously treat patients with unresectable or metastatic melanoma and disease progression following treatment with Yervoy.
Currently, Opdivo is approved both as a monotherapy and in combination with Yervoy to treat a plethora of cancer indications in many countries, including the United States and EU.
In the past year, shares of Bristol Myers have plunged 32% compared with the industry’s 11.7% decline.
Image Source: Zacks Investment Research
Per management, the CheckMate-77T study evaluated the potential for neoadjuvant immunotherapy to induce pathological complete response and the role of perioperative Opdivo treatment in reducing the likelihood that cancer will return, which is expected to extend the survival of patients.
Benefits in key secondary endpoints, including pathologic complete response and major pathologic response, were also observed in the late-stage study.
Furthermore, the perioperative regimen had a safety profile consistent with previously reported studies in NSCLC. No new safety signals were identified.
To date, Opdivo and Opdivo-based combinations have shown efficacy benefits in the neoadjuvant, adjuvant or perioperative settings across four cancers, including lung cancer, bladder cancer, esophageal/gastroesophageal junction cancer and melanoma.
The company is currently evaluating Opdivo in different clinical studies spread across all phases in a variety of tumor types.
Opdivo has also been driving growth in 2023 for Bristol Myers, which recorded $9 billion in sales, up 10% year over year.
NSCLC is one of the most common types of lung cancer, representing up to 84% of diagnoses.
Currently, Merck (MRK - Free Report) markets Keytruda (pembrolizumab) as the standard of care in the frontline treatment of metastatic NSCLC. Keytruda, an anti-PD-1 therapy, is Merck’s blockbuster oncology drug and is approved for several types of cancer, accounting alone for around 45% of the company’s pharmaceutical sales.
Merck’s Keytruda is presently approved to treat eight indications in earlier-stage cancers in the United States. Keytruda is continuously growing and expanding into new indications and markets globally, bolstering Merck’s position in the oncology market.
In the past 30 days, the Zacks Consensus Estimate for Puma Biotech’s 2023 earnings per share (EPS) has remained constant at 73 cents. During the same time frame, the consensus estimate for Puma Biotech’s 2024 EPS has remained constant at 69 cents. Over the past year, shares of PBYI have gained 10.3%.
PBYI beat estimates in three of the last four quarters while missing on one occasion, delivering a four-quarter average earnings surprise of 76.55%.
In the past 30 days, the Zacks Consensus Estimate for ImmunoGen’s 2023 EPS has remained constant at 7 cents. During the same period, the consensus estimate for ImmunoGen’s 2024 EPS has remained constant at 37 cents. Over the past year, shares of IMGN have skyrocketed 601.9%.
IMGN beat estimates in each of the trailing four quarters, delivering an average earnings surprise of 136.05%.
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Bristol Myers' (BMY) Opdivo Label Expansion Filings Get Accepted
Bristol Myers (BMY - Free Report) announced the acceptance of its regulatory applications for neoadjuvant Opdivo (nivolumab) with chemotherapy followed by surgery and adjuvant Opdivo for the perioperative treatment of resectable stage IIA to IIIB non-small cell lung cancer (NSCLC) in the United States and EU.
A decision from the FDA regarding the Opdivo supplemental biologics license application is expected on Oct 8, 2024. The application seeking marketing approval for this expanded indication of Opdivo in the EU was validated by the European Medicines Agency (EMA) in late January and is currently under review.
The submissions to the FDA and EMA were based on positive results from the phase III CheckMate -77T study demonstrating statistically significant and clinically meaningful improvements in event-free survival, which is the study’s primary endpoint.
Opdivo, the company’s PD-1 immune checkpoint inhibitor, was initially approved in 2014 to intravenously treat patients with unresectable or metastatic melanoma and disease progression following treatment with Yervoy.
Currently, Opdivo is approved both as a monotherapy and in combination with Yervoy to treat a plethora of cancer indications in many countries, including the United States and EU.
In the past year, shares of Bristol Myers have plunged 32% compared with the industry’s 11.7% decline.
Image Source: Zacks Investment Research
Per management, the CheckMate-77T study evaluated the potential for neoadjuvant immunotherapy to induce pathological complete response and the role of perioperative Opdivo treatment in reducing the likelihood that cancer will return, which is expected to extend the survival of patients.
Benefits in key secondary endpoints, including pathologic complete response and major pathologic response, were also observed in the late-stage study.
Furthermore, the perioperative regimen had a safety profile consistent with previously reported studies in NSCLC. No new safety signals were identified.
To date, Opdivo and Opdivo-based combinations have shown efficacy benefits in the neoadjuvant, adjuvant or perioperative settings across four cancers, including lung cancer, bladder cancer, esophageal/gastroesophageal junction cancer and melanoma.
The company is currently evaluating Opdivo in different clinical studies spread across all phases in a variety of tumor types.
Opdivo has also been driving growth in 2023 for Bristol Myers, which recorded $9 billion in sales, up 10% year over year.
NSCLC is one of the most common types of lung cancer, representing up to 84% of diagnoses.
Currently, Merck (MRK - Free Report) markets Keytruda (pembrolizumab) as the standard of care in the frontline treatment of metastatic NSCLC. Keytruda, an anti-PD-1 therapy, is Merck’s blockbuster oncology drug and is approved for several types of cancer, accounting alone for around 45% of the company’s pharmaceutical sales.
Merck’s Keytruda is presently approved to treat eight indications in earlier-stage cancers in the United States. Keytruda is continuously growing and expanding into new indications and markets globally, bolstering Merck’s position in the oncology market.
Bristol Myers Squibb Company Price and Consensus
Bristol Myers Squibb Company price-consensus-chart | Bristol Myers Squibb Company Quote
Zacks Rank and Stocks to Consider
Bristol Myers currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks from the drug/biotech industry are Puma Biotechnology, Inc. (PBYI - Free Report) and ImmunoGen , sporting a Zacks Rank #1 (Strong Buy) each at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 30 days, the Zacks Consensus Estimate for Puma Biotech’s 2023 earnings per share (EPS) has remained constant at 73 cents. During the same time frame, the consensus estimate for Puma Biotech’s 2024 EPS has remained constant at 69 cents. Over the past year, shares of PBYI have gained 10.3%.
PBYI beat estimates in three of the last four quarters while missing on one occasion, delivering a four-quarter average earnings surprise of 76.55%.
In the past 30 days, the Zacks Consensus Estimate for ImmunoGen’s 2023 EPS has remained constant at 7 cents. During the same period, the consensus estimate for ImmunoGen’s 2024 EPS has remained constant at 37 cents. Over the past year, shares of IMGN have skyrocketed 601.9%.
IMGN beat estimates in each of the trailing four quarters, delivering an average earnings surprise of 136.05%.