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FDA Accepts Roche's (RHHBY) Application for Adjuvant Perjeta
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Roche Holdings AG (RHHBY - Free Report) announced that the FDA has accepted the company’s supplemental Biologics License Application (sBLA) and granted Priority Review for breast cancer drug Perjeta, in combination with Herceptin (trastuzumab) and chemotherapy (the Perjeta-based regimen), for adjuvant (after surgery) treatment of HER2-positive early breast cancer (eBC).
The sBLA seeks to convert the current accelerated approval to full approval in the United States. A decision on the same’s approval is expected by Jan 28, 2018.
We remind investors that a priority review designation is granted to drugs that the FDA determines have the potential to provide significant improvements in the treatment, prevention or diagnosis of a disease. We note that the combination of Perjeta, Herceptin and chemotherapy is already approved as a neoadjuvant (before surgery) treatment for people with HER2-positive eBC in the United States and Europe.
Roche has a strong presence in the oncology market. The company dominates the breast cancer space with strong demand for its HER2 franchise drugs like Herceptin, Perjeta and Kadcyla. Growth in Herceptin is being driven by improved demand in both the United Staes and Europe due to longer treatment duration. Moreover, the subcutaneous formulation of Herceptin is being increasingly adopted across Europe. Meanwhile, the sales of Perjeta has been strong in Europe largely due to uptake in the neo-adjuvant setting and persistent growth in the metastatic setting. Kadcyla sales are being driven by increasing demand in both the Europe and internationally.
Apart from its strong breast cancer franchise, Roche’s oncology portfolio also boasts drugs like Avastin and Tarceva for lung cancer.
Roche’s stock has rallied 15.5% year to date compared with industry’s gain of 20.6%.
However, sales of Avastin and Tarceva continue to decline. Generic competition for Xeloda continues to hurt sales. Competition from biosimilars looms large on Roche's key drugs like Herceptin, Avastin and Rituxan. The FDA accepted Novartis AG’s (NVS - Free Report) Biologics License Application for a proposed biosimilar version of Rituxan. Hence, approval of new drugs and label expansion of existing drugs will bode well for Roche.
Zacks Rank & Key Picks
Roche currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the health care sector are Regeneron Pharmaceuticals, Inc. (REGN - Free Report) and Aduro Biotech, Inc. . While Regeneron sports a Zacks Rank #1 (Strong Buy), Aduro is a Zacks Rank #2 (Buy) stock. You can see the complete list of today’s Zacks #1 Rank stocks here.
Regeneron’s earnings per share estimates have increased from $14.69 to $14.99 for 2017 and from $16.46 to $16.65 for 2018 over the last 60 days. The company posted positive earnings surprises in two of the trailing four quarters, with an average of 10.11%. The share price of the company has increased 17.9% year to date.
Aduro Biotech’s loss per share estimates narrowed from $1.36 to $1.29 for 2017 over the last 30 days. The company delivered positive earnings surprises in two of the four trailing quarters with an average of 2.53%.
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FDA Accepts Roche's (RHHBY) Application for Adjuvant Perjeta
Roche Holdings AG (RHHBY - Free Report) announced that the FDA has accepted the company’s supplemental Biologics License Application (sBLA) and granted Priority Review for breast cancer drug Perjeta, in combination with Herceptin (trastuzumab) and chemotherapy (the Perjeta-based regimen), for adjuvant (after surgery) treatment of HER2-positive early breast cancer (eBC).
The sBLA seeks to convert the current accelerated approval to full approval in the United States. A decision on the same’s approval is expected by Jan 28, 2018.
We remind investors that a priority review designation is granted to drugs that the FDA determines have the potential to provide significant improvements in the treatment, prevention or diagnosis of a disease. We note that the combination of Perjeta, Herceptin and chemotherapy is already approved as a neoadjuvant (before surgery) treatment for people with HER2-positive eBC in the United States and Europe.
Roche has a strong presence in the oncology market. The company dominates the breast cancer space with strong demand for its HER2 franchise drugs like Herceptin, Perjeta and Kadcyla. Growth in Herceptin is being driven by improved demand in both the United Staes and Europe due to longer treatment duration. Moreover, the subcutaneous formulation of Herceptin is being increasingly adopted across Europe. Meanwhile, the sales of Perjeta has been strong in Europe largely due to uptake in the neo-adjuvant setting and persistent growth in the metastatic setting. Kadcyla sales are being driven by increasing demand in both the Europe and internationally.
Apart from its strong breast cancer franchise, Roche’s oncology portfolio also boasts drugs like Avastin and Tarceva for lung cancer.
Roche’s stock has rallied 15.5% year to date compared with industry’s gain of 20.6%.
However, sales of Avastin and Tarceva continue to decline. Generic competition for Xeloda continues to hurt sales. Competition from biosimilars looms large on Roche's key drugs like Herceptin, Avastin and Rituxan. The FDA accepted Novartis AG’s (NVS - Free Report) Biologics License Application for a proposed biosimilar version of Rituxan. Hence, approval of new drugs and label expansion of existing drugs will bode well for Roche.
Zacks Rank & Key Picks
Roche currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the health care sector are Regeneron Pharmaceuticals, Inc. (REGN - Free Report) and Aduro Biotech, Inc. . While Regeneron sports a Zacks Rank #1 (Strong Buy), Aduro is a Zacks Rank #2 (Buy) stock. You can see the complete list of today’s Zacks #1 Rank stocks here.
Regeneron’s earnings per share estimates have increased from $14.69 to $14.99 for 2017 and from $16.46 to $16.65 for 2018 over the last 60 days. The company posted positive earnings surprises in two of the trailing four quarters, with an average of 10.11%. The share price of the company has increased 17.9% year to date.
Aduro Biotech’s loss per share estimates narrowed from $1.36 to $1.29 for 2017 over the last 30 days. The company delivered positive earnings surprises in two of the four trailing quarters with an average of 2.53%.
Will You Make a Fortune on the Shift to Electric Cars?
Here's another stock idea to consider. Much like petroleum 150 years ago, lithium power may soon shake the world, creating millionaires and reshaping geo-politics. Soon electric vehicles (EVs) may be cheaper than gas guzzlers. Some are already reaching 265 miles on a single charge.
With battery prices plummeting and charging stations set to multiply, one company stands out as the #1 stock to buy according to Zacks research.
It's not the one you think.
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