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Bristol-Myers' Injectable Opdivo Gets FDA Approval for mUC
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Bristol-Myers Squibb Company (BMY - Free Report) announced that the FDA has approved an injectable form of immuno-oncology drug Opdivo. The drug will have an intravenous use in metastatic urothelial carcinoma (mUC) with a recommended dose of 240 mg. Opdivo will be administered as an intravenous infusion over 60 minutes every two weeks until disease progression or unacceptable toxicity.
The FDA approved the use of injectable Opdivo for the treatment of patients with locally advanced or mUC whose disease has progressed during or following platinum-containing chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy under an accelerated approval program based on tumor response rate and duration of response.
We note that approval for this indication will be contingent upon verification and description of clinical benefit in confirmatory trials.
In the past one year, Bristol-Myers’ share price was down 16%, compared with the 0.1% increase witnessed by the Zacks classified Large-Cap Pharma industry.
We remind investors that Opdivo is currently approved in several countries including the U.S., the EU and Japan for several cancer indications. Opdivo continues to be launched globally on approvals and label expansions. The drug has been performing impressively due to demand resulting from rapid commercial acceptance for melanoma, renal cell carcinoma, and second-line non-small-cell lung cancer (NSCLC).
However, the lung-cancer market in the U.S became more competitive in 2016 due to the entry of Roche’s (RHHBY - Free Report) Tecentriq in the second-line setting. Consequently, Bristol-Myers stated that the sales of the drug in the U.S will be flat in 2017 due to competitive pressure. A potential earlier-than-expected entry of Merck's. (MRK - Free Report) Keytruda in combination with chemotherapy will also adversely impact sales. Nevertheless, sales in the international markets should continue to grow.
Note that shares of Bristol-Myers have been under pressure since Aug 2016. 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 reported final primary analysis in Oct 2016.
Bristol-Myers hasn’t been very successful in its attempts to expand Opdivo’s label to include first-line lung cancer thereby given rival Merck an edge in the same.
A better-raked stock in the Large Cap Pharmaceutical group is Eli Lilly (LLY - Free Report) which currently holds a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here. Eli Lilly’s earnings estimates are up by a cent in the last seven days for both 2017 and 2018.
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Bristol-Myers' Injectable Opdivo Gets FDA Approval for mUC
Bristol-Myers Squibb Company (BMY - Free Report) announced that the FDA has approved an injectable form of immuno-oncology drug Opdivo. The drug will have an intravenous use in metastatic urothelial carcinoma (mUC) with a recommended dose of 240 mg. Opdivo will be administered as an intravenous infusion over 60 minutes every two weeks until disease progression or unacceptable toxicity.
The FDA approved the use of injectable Opdivo for the treatment of patients with locally advanced or mUC whose disease has progressed during or following platinum-containing chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy under an accelerated approval program based on tumor response rate and duration of response.
We note that approval for this indication will be contingent upon verification and description of clinical benefit in confirmatory trials.
In the past one year, Bristol-Myers’ share price was down 16%, compared with the 0.1% increase witnessed by the Zacks classified Large-Cap Pharma industry.
We remind investors that Opdivo is currently approved in several countries including the U.S., the EU and Japan for several cancer indications. Opdivo continues to be launched globally on approvals and label expansions. The drug has been performing impressively due to demand resulting from rapid commercial acceptance for melanoma, renal cell carcinoma, and second-line non-small-cell lung cancer (NSCLC).
However, the lung-cancer market in the U.S became more competitive in 2016 due to the entry of Roche’s (RHHBY - Free Report) Tecentriq in the second-line setting. Consequently, Bristol-Myers stated that the sales of the drug in the U.S will be flat in 2017 due to competitive pressure. A potential earlier-than-expected entry of Merck's. (MRK - Free Report) Keytruda in combination with chemotherapy will also adversely impact sales. Nevertheless, sales in the international markets should continue to grow.
Note that shares of Bristol-Myers have been under pressure since Aug 2016. 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 reported final primary analysis in Oct 2016.
Bristol-Myers hasn’t been very successful in its attempts to expand Opdivo’s label to include first-line lung cancer thereby given rival Merck an edge in the same.
Bristol-Myers Squibb Company Price and Consensus
Bristol-Myers Squibb Company Price and Consensus | Bristol-Myers Squibb Company Quote
Zacks Rank & Key Pick
Bristol-Myers carries a Zacks Rank #3 (Hold).
A better-raked stock in the Large Cap Pharmaceutical group is Eli Lilly (LLY - Free Report) which currently holds a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here. Eli Lilly’s earnings estimates are up by a cent in the last seven days for both 2017 and 2018.
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 >>