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Bristol-Myers Declines, FDA Delays Review of Opdivo for NSCLC
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Shares of Bristol-Myers Squibb Company (BMY - Free Report) lost more than 6% after the FDA extended the review timeline regarding the supplemental Biologics License Application (sBLA) of its blockbuster immuno-oncology drug Opdivo for treating metastatic first-line non-small cell lung cancer (NSCLC).
In fact, so far this year, Bristol-Myers stock has decreased 16.9% against the industry’s increase of 6.1%.
The sBLA is seeking an approval for Opdivo in combination with low-dose Yervoy pertaining to patients with tumor mutational burden (TMB) of at least 10 mutations/megabase (mut/Mb). The review period is stretched by three months.
Previously, the regulatory body was expected to render its decision on Feb 20, 2019. However, the FDA delayed its verdict by three months and has now set an action date of May 20, 2019.
In June 2018, Bristol-Myers announced updated data from a portion of the phase III study, Checkmate-227, which met the co-primary endpoint of improved progression free survival for the Opdivo and Yervoy combination compared with chemotherapy for the treatment of first-line NSCLC.
The FDA postponed the date to allow some time for reviewing the company's overall survival (OS) data related to the subgroup of patients with tumor burden less than 10 mut/Mb. The regulatory agency now thinks that this new information comprises a major amendment to the sBLA.
In Europe too, the Committee for Medicinal Products for Human Use (CHMP) requested an extension of the stop clock to provide it with some time for evaluating the same OS data. Both filings were based on the phase III CheckMate -227 study.
Notably, Opdivo became the first PD-1 immune checkpoint inhibitor to gain a regulatory nod. It is currently approved in several countries including the United States, the EU and Japan for multiple cancer indications. Many label expansion applications for Opdivo are under review in the United States and Europe. The FDA recently approved Opdivo plus Yervoy in first-line renal cell carcinoma (RCC) across the United States. The combination is now approved for three tumors such as renal, colorectal and melanoma. Uptake of the drug continues to be strong particularly in new indications like the first line renal cell and adjuvant melanoma.
However, Opdivo faces a stiff competition from Merck’s (MRK - Free Report) anti-PD-1 therapy, Keytruda, which is approved in the first-line lung cancer setting. Also, Roche’s (RHHBY - Free Report) anti-PDL1 immunotherapy, Tecentriq, is approved for the treatment of metastatic NSCLC.
J&J’s earnings estimates have moved 0.2% north for 2018 and 0.2% for 2019 over the past 60 days. The stock has gained 7.2% in the past three months.
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It's hard to believe, even for us at Zacks. But while the market gained +21.9% in 2017, our top stock-picking screens have returned +115.0%, +109.3%, +104.9%, +98.6%, and +67.1%.
And this outperformance has not just been a recent phenomenon. Over the years it has been remarkably consistent. From 2000 - 2017, the composite yearly average gain for these strategies has beaten the market more than 19X over. Maybe even more remarkable is the fact that we're willing to share their latest stocks with you without cost or obligation.
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Bristol-Myers Declines, FDA Delays Review of Opdivo for NSCLC
Shares of Bristol-Myers Squibb Company (BMY - Free Report) lost more than 6% after the FDA extended the review timeline regarding the supplemental Biologics License Application (sBLA) of its blockbuster immuno-oncology drug Opdivo for treating metastatic first-line non-small cell lung cancer (NSCLC).
In fact, so far this year, Bristol-Myers stock has decreased 16.9% against the industry’s increase of 6.1%.
The sBLA is seeking an approval for Opdivo in combination with low-dose Yervoy pertaining to patients with tumor mutational burden (TMB) of at least 10 mutations/megabase (mut/Mb). The review period is stretched by three months.
Previously, the regulatory body was expected to render its decision on Feb 20, 2019. However, the FDA delayed its verdict by three months and has now set an action date of May 20, 2019.
In June 2018, Bristol-Myers announced updated data from a portion of the phase III study, Checkmate-227, which met the co-primary endpoint of improved progression free survival for the Opdivo and Yervoy combination compared with chemotherapy for the treatment of first-line NSCLC.
The FDA postponed the date to allow some time for reviewing the company's overall survival (OS) data related to the subgroup of patients with tumor burden less than 10 mut/Mb. The regulatory agency now thinks that this new information comprises a major amendment to the sBLA.
In Europe too, the Committee for Medicinal Products for Human Use (CHMP) requested an extension of the stop clock to provide it with some time for evaluating the same OS data. Both filings were based on the phase III CheckMate -227 study.
Notably, Opdivo became the first PD-1 immune checkpoint inhibitor to gain a regulatory nod. It is currently approved in several countries including the United States, the EU and Japan for multiple cancer indications. Many label expansion applications for Opdivo are under review in the United States and Europe. The FDA recently approved Opdivo plus Yervoy in first-line renal cell carcinoma (RCC) across the United States. The combination is now approved for three tumors such as renal, colorectal and melanoma. Uptake of the drug continues to be strong particularly in new indications like the first line renal cell and adjuvant melanoma.
However, Opdivo faces a stiff competition from Merck’s (MRK - Free Report) anti-PD-1 therapy, Keytruda, which is approved in the first-line lung cancer setting. Also, Roche’s (RHHBY - Free Report) anti-PDL1 immunotherapy, Tecentriq, is approved for the treatment of metastatic NSCLC.
Bristol-Myers Squibb Company Price and Consensus
Bristol-Myers Squibb Company Price and Consensus | Bristol-Myers Squibb Company Quote
Zacks Rank & Another Key Pick
Bristol-Myers currently carries a Zacks Rank #2 (Buy). Another top-ranked stock from the same space is Johnson & Johnson (JNJ - Free Report) , which holds the same top Zacks Rank of 2 as Bristol-Myers. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
J&J’s earnings estimates have moved 0.2% north for 2018 and 0.2% for 2019 over the past 60 days. The stock has gained 7.2% in the past three months.
Today's Stocks from Zacks' Hottest Strategies
It's hard to believe, even for us at Zacks. But while the market gained +21.9% in 2017, our top stock-picking screens have returned +115.0%, +109.3%, +104.9%, +98.6%, and +67.1%.
And this outperformance has not just been a recent phenomenon. Over the years it has been remarkably consistent. From 2000 - 2017, the composite yearly average gain for these strategies has beaten the market more than 19X over. Maybe even more remarkable is the fact that we're willing to share their latest stocks with you without cost or obligation.
See Them Free>>