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Bristol-Myers Offer Updates on Opdivo+Yervoy Combination
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Shares of Bristol-Myers Squibb Company (BMY - Free Report) fell 5% in afterhours trading on Jan 19 after the company disclosed that it will not seek an accelerated approval in the U.S. for a combination of its two immuno-oncology treatments, Opdivo plus Yervoy, for first-line lung cancer. The company said the decision was based on a review of data that are available at this time.
However, the company refrained from providing additional details in order to protect the integrity of ongoing registrational studies.
Shares of Bristol-Myers have underperformed the Zacks classified Large Cap Pharmaceuticals industry in the past one year. The stock lost 10.5% during this period, while the industry gained 4.1%.
Note that shares of Bristol-Myers have been under pressure since Aug 2016 when the company announced disappointing top-line data from the phase III CheckMate -026 study evaluating the use of Opdivo monotherapy in treatment-naïve patients with advanced non-small cell lung cancer (NSCLC). Data showed that the study failed to meet the primary endpoint of progression-free survival in patients with ≥5% PD-L1 expression. The company had reported final primary analysis in Oct 2016.
As a matter of fact, Bristol-Myers hasn’t been very successful in its attempts to expand Opdivo’s label to include first-line lung cancer.
Meanwhile, Merck & Co., Inc.'s (MRK - Free Report) shares gained 4.7% on the news during afterhours trading. In fact, Merck gained 23.2% in the past one year, significantly outperforming the broader industry.
Earlier this month, Merck announced that the FDA has accepted its regulatory application for a label expansion of its anti-PD-1 therapy, Keytruda, under accelerated approval and granted priority review status to the application. The company is looking to expand the label of Keytruda, in combination with chemotherapy (pemetrexed plus carboplatin), for the first-line treatment of patients with metastatic NSCLC, regardless of PD-L1 expression and with no EGFR or ALK genomic tumor aberration. A final decision is expected by May 10, 2017.
Given the latest development, an approval could give Merck a head start in this market.
We note that Keytruda gained FDA approval in Oct 2016 for the first-line treatment of patients with metastatic NSCLC whose tumors have high PD-L1 expression (tumor proportion score of 50% or more) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberration. Keytruda thus became the only anti-PD-1 therapy to be approved for the first-line treatment of metastatic NSCLC.
Opdivo Positive in Advanced Gastric Cancer Study
In a separate press release, Bristol-Myers announced data from a randomized, double-blind, placebo-controlled phase III study (ONO-4538-12) evaluating the efficacy and safety of Opdivo in patients with previously treated advanced gastric cancer refractory to or intolerant of standard therapy. Study data were presented at the Gastrointestinal Cancers Symposium.
Data showed that Opdivo significantly reduced the risk of death by 37% in patients. Moreover, the 12-month overall survival rates in the Opdivo group were 26.6% in Opdivo-treated patients in comparison to 10.9% in the placebo group.
On the safety front, Opdivo was consistent with the previous studies in solid tumors. This is the first phase III immuno-oncology study to demonstrate improved survival for patients with previously treated advanced or recurrent gastric cancer.
While Bristol-Myers is a Zacks Rank #4 (Sell) stock, Merck carries a Zacks Rank #3 (Hold).
Nivalis’ loss estimates narrowed from $2.14 to $2.08 for 2016 and from $2.35 to $1.81 for 2017 over the last 60 days.
Anika’s earnings estimates for 2016 and 2017 were up 3.9% and 0.5%, respectively, over the last 60 days. The company recorded a positive earnings surprise in each of the last four quarters, the average being 33.14%. Its share price was up 37.1% in the past one year.
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Today, you are invited to download the full list of 220 Zacks Rank #1 "Strong Buy" stocks – absolutely free of charge. Since 1988, Zacks Rank #1 stocks have nearly tripled the market, with average gains of +26% per year. Plus, you can access the list of portfolio-killing Zacks Rank #5 "Strong Sells" and other private research. See these stocks free >>
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Bristol-Myers Offer Updates on Opdivo+Yervoy Combination
Shares of Bristol-Myers Squibb Company (BMY - Free Report) fell 5% in afterhours trading on Jan 19 after the company disclosed that it will not seek an accelerated approval in the U.S. for a combination of its two immuno-oncology treatments, Opdivo plus Yervoy, for first-line lung cancer. The company said the decision was based on a review of data that are available at this time.
However, the company refrained from providing additional details in order to protect the integrity of ongoing registrational studies.
Shares of Bristol-Myers have underperformed the Zacks classified Large Cap Pharmaceuticals industry in the past one year. The stock lost 10.5% during this period, while the industry gained 4.1%.
Note that shares of Bristol-Myers have been under pressure since Aug 2016 when the company announced disappointing top-line data from the phase III CheckMate -026 study evaluating the use of Opdivo monotherapy in treatment-naïve patients with advanced non-small cell lung cancer (NSCLC). Data showed that the study failed to meet the primary endpoint of progression-free survival in patients with ≥5% PD-L1 expression. The company had reported final primary analysis in Oct 2016.
As a matter of fact, Bristol-Myers hasn’t been very successful in its attempts to expand Opdivo’s label to include first-line lung cancer.
Meanwhile, Merck & Co., Inc.'s (MRK - Free Report) shares gained 4.7% on the news during afterhours trading. In fact, Merck gained 23.2% in the past one year, significantly outperforming the broader industry.
Earlier this month, Merck announced that the FDA has accepted its regulatory application for a label expansion of its anti-PD-1 therapy, Keytruda, under accelerated approval and granted priority review status to the application. The company is looking to expand the label of Keytruda, in combination with chemotherapy (pemetrexed plus carboplatin), for the first-line treatment of patients with metastatic NSCLC, regardless of PD-L1 expression and with no EGFR or ALK genomic tumor aberration. A final decision is expected by May 10, 2017.
Given the latest development, an approval could give Merck a head start in this market.
We note that Keytruda gained FDA approval in Oct 2016 for the first-line treatment of patients with metastatic NSCLC whose tumors have high PD-L1 expression (tumor proportion score of 50% or more) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberration. Keytruda thus became the only anti-PD-1 therapy to be approved for the first-line treatment of metastatic NSCLC.
Opdivo Positive in Advanced Gastric Cancer Study
In a separate press release, Bristol-Myers announced data from a randomized, double-blind, placebo-controlled phase III study (ONO-4538-12) evaluating the efficacy and safety of Opdivo in patients with previously treated advanced gastric cancer refractory to or intolerant of standard therapy. Study data were presented at the Gastrointestinal Cancers Symposium.
Data showed that Opdivo significantly reduced the risk of death by 37% in patients. Moreover, the 12-month overall survival rates in the Opdivo group were 26.6% in Opdivo-treated patients in comparison to 10.9% in the placebo group.
On the safety front, Opdivo was consistent with the previous studies in solid tumors. This is the first phase III immuno-oncology study to demonstrate improved survival for patients with previously treated advanced or recurrent gastric cancer.
While Bristol-Myers is a Zacks Rank #4 (Sell) stock, Merck carries a Zacks Rank #3 (Hold).
Stocks to Consider
A couple of better-ranked stocks in the health care sector include Anika Therapeutics, Inc. (ANIK - Free Report) and Nivalis Therapeutics, Inc. . Both the stocks sport a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Nivalis’ loss estimates narrowed from $2.14 to $2.08 for 2016 and from $2.35 to $1.81 for 2017 over the last 60 days.
Anika’s earnings estimates for 2016 and 2017 were up 3.9% and 0.5%, respectively, over the last 60 days. The company recorded a positive earnings surprise in each of the last four quarters, the average being 33.14%. Its share price was up 37.1% in the past one year.
The Best Place to Start Your Stock Search
Today, you are invited to download the full list of 220 Zacks Rank #1 "Strong Buy" stocks – absolutely free of charge. Since 1988, Zacks Rank #1 stocks have nearly tripled the market, with average gains of +26% per year. Plus, you can access the list of portfolio-killing Zacks Rank #5 "Strong Sells" and other private research. See these stocks free >>