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Bristol-Myers' (BMY) sBLA For Opdivo Accepted by the FDA
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Bristol-Myers Squibb Company (BMY - Free Report) recently announced that the FDA has accepted the company’s supplemental Biologics License Application (sBLA) for the label expansion of immune-oncology drug, Opdivo. The company is looking to expand Opdivo’s label for the treatment of patients with mismatch repair deficient (dMMR) or microsatellite instability high (MSI-H) metastatic colorectal cancer (CRC) after prior fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy.
The FDA granted priority review to the application with an action date of Aug 2.
The sBLA was submitted based on data from the ongoing phase II study, CheckMate -142 which evaluated Opdivo in patients with dMMR or MSI-H metastatic CRC.
We remind investors that Opdivo is approved for varied indications in both EU and the U.S. Opdivo has received approvals for several indications including melanoma, head and neck, lung, kidney and blood cancer. The Opdivo+Yervoy regimen is also approved in multiple markets for the treatment of melanoma.
The drug recorded sales of $3.4 billion in 2016, up from $942 million in 2015. Bristol-Myers is working on expanding the label of Opdivo further. Opdivo became the first PD-1 inhibitor to be approved for a hematological malignancy – classical Hodgkin lymphoma in both the U.S. (May 2016) and the EU (Nov 2016). In Nov 2016, Opdivo gained the FDA approval for the treatment of patients with recurrent or metastatic squamous cell carcinoma of the head and neck with disease progression on or after platinum-based therapy.
Label expansion into additional indications would give the product access to a higher patient population and increase the commercial potential of the drug.
However, the company suffered a setback in Jan 2017 when it decided not to pursue accelerated regulatory pathway for the regimen of Opdivo plus Yervoy in first-line lung cancer in the U.S. based on a review of available data. A potential earlier-than-expected entry of Merck’s (MRK - Free Report) Keytruda in combination with chemotherapy for the same will further impact Opdivo sales.
While Bristol-Myers’ share price decreased 9.2% in the last 12 months, the Zacks classified Large Cap Pharmaceuticals industry gained 6.7%.
Zacks Rank & Stocks to Consider
Bristol-Myers currently carries a Zacks Rank #3 (Hold).
A couple of better-ranked stocks in the health care sector are Heska Corporation and Retrophin, 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.
Heska’s earnings per share estimates increased from $1.53 to $1.65 for 2017 and from $1.90 to $2.01 for 2018 over the last 30 days. The company posted a positive surprise in three of the four trailing quarters with an average beat of 291.54%.
Retrophin’s loss per share estimates narrowed from 85 cents to 72 cents for 2017 and from 67 cents to 53 cents for 2018 over the last 60 days. The company posted positive earnings surprises in two of the four trailing quarters, with an average beat of 80.55%.
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Bristol-Myers' (BMY) sBLA For Opdivo Accepted by the FDA
Bristol-Myers Squibb Company (BMY - Free Report) recently announced that the FDA has accepted the company’s supplemental Biologics License Application (sBLA) for the label expansion of immune-oncology drug, Opdivo. The company is looking to expand Opdivo’s label for the treatment of patients with mismatch repair deficient (dMMR) or microsatellite instability high (MSI-H) metastatic colorectal cancer (CRC) after prior fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy.
The FDA granted priority review to the application with an action date of Aug 2.
The sBLA was submitted based on data from the ongoing phase II study, CheckMate -142 which evaluated Opdivo in patients with dMMR or MSI-H metastatic CRC.
We remind investors that Opdivo is approved for varied indications in both EU and the U.S. Opdivo has received approvals for several indications including melanoma, head and neck, lung, kidney and blood cancer. The Opdivo+Yervoy regimen is also approved in multiple markets for the treatment of melanoma.
The drug recorded sales of $3.4 billion in 2016, up from $942 million in 2015. Bristol-Myers is working on expanding the label of Opdivo further. Opdivo became the first PD-1 inhibitor to be approved for a hematological malignancy – classical Hodgkin lymphoma in both the U.S. (May 2016) and the EU (Nov 2016). In Nov 2016, Opdivo gained the FDA approval for the treatment of patients with recurrent or metastatic squamous cell carcinoma of the head and neck with disease progression on or after platinum-based therapy.
Label expansion into additional indications would give the product access to a higher patient population and increase the commercial potential of the drug.
However, the company suffered a setback in Jan 2017 when it decided not to pursue accelerated regulatory pathway for the regimen of Opdivo plus Yervoy in first-line lung cancer in the U.S. based on a review of available data. A potential earlier-than-expected entry of Merck’s (MRK - Free Report) Keytruda in combination with chemotherapy for the same will further impact Opdivo sales.
While Bristol-Myers’ share price decreased 9.2% in the last 12 months, the Zacks classified Large Cap Pharmaceuticals industry gained 6.7%.
Zacks Rank & Stocks to Consider
Bristol-Myers currently carries a Zacks Rank #3 (Hold).
A couple of better-ranked stocks in the health care sector are Heska Corporation and Retrophin, 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.
Heska’s earnings per share estimates increased from $1.53 to $1.65 for 2017 and from $1.90 to $2.01 for 2018 over the last 30 days. The company posted a positive surprise in three of the four trailing quarters with an average beat of 291.54%.
Retrophin’s loss per share estimates narrowed from 85 cents to 72 cents for 2017 and from 67 cents to 53 cents for 2018 over the last 60 days. The company posted positive earnings surprises in two of the four trailing quarters, with an average beat of 80.55%.
Zacks’ Best Private Investment Ideas
In addition to the recommendations that are available to the public on our website, how would you like to follow all Zacks' private buys and sells in real time?
Our experts cover all kinds of trades… from value to momentum . . . from stocks under $10 to ETF and option moves . . . from stocks that corporate insiders are buying up to companies that are about to report positive earnings surprises. You can even look inside exclusive portfolios that are normally closed to new investors. Starting today, for the next month, you can have unrestricted access. Click here for Zacks' private trades >>