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Roche's (RHHBY) Influenza Drug Gets Positive CHMP Opinion
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Roche (RHHBY - Free Report) announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of influenza drug Xofluza (baloxavir marboxil).
The drug is recommended for an approval to treat uncomplicated influenza in patients aged 12 years and above. In addition, the medicine recommended for a regulatory nod as a preventive treatment (post-exposure prophylaxis) of influenza in individuals aged 12 years and above.
The CHMP recommendation was based on the results of the phase III CAPSTONE-1, CAPSTONE-2 and BLOCKSTONE studies. A final decision regarding the approval is expected from the European Commission shortly.
Xofluza is approved in the United States for the treatment of acute, uncomplicated influenza in patients aged 12 years and above who are otherwise healthy or at high risk of developing serious complications from influenza and who have been symptomatic for not more than 48 hours. The product was the first new antiviral to be approved by the FDA in 20 years.
Concurrently, the CHMP also commended the approval of Phesgo, a fixed-dose combination of Perjeta (pertuzumab) and Herceptin (trastuzumab) with hyaluronidase, administered by a subcutaneous (under the skin) injection in combination with intravenous (IV) chemotherapy for the treatment of early and metastatic HER2-positive breast cancer.
Phesgo offers faster and less invasive delivery of the standard of care treatment with Perjeta and Herceptin under the skin in just a few minutes compared to hours with intravenous infusion. The FDA recently expedited the approval of Phesgo for the treatment of early and metastatic HER2-positive breast cancer.
The stock has gained 12.5% in the past year compared with the industry’s growth of 7.3%.
Label expansion of Roche’s existing drugs should boost its sales as the company’s performance on that count in the first nine months of 2020 was pretty ho-hum due to the impact of the COVID-19 outbreak and competition from biosimilars.
Growth in the newly-launched medicines, such as multiple sclerosis drug Ocrevus, hemophilia drug Hemlibra, immuno-oncology drug Tecentriq and breast cancer drug Perjeta was offset by the impact of biosimilar competition for older drugs and the COVID-19 pandemic.
Nevertheless, demand for Roche’s diagnostic tests should maintain the momentum.
Meanwhile, Roche entered into a partnership with Regeneron (REGN - Free Report) for its new antiviral antibody cocktail to fight COVID-19. Initial data showed that the REGNCOV2 antibody cocktail reduced the viral levels and improved symptoms in the non-hospitalized COVID-19 patients.
Vanda’s earnings estimates have been raised 12 cents for 2020 in the past 30 days.
Cara’s loss estimates have narrowed 32 cents for 2020 in the past 30 days.
The Hottest Tech Mega-Trend of All
Last year, it generated $24 billion in global revenues. By 2020, it's predicted to blast through the roof to $77.6 billion. Famed investor Mark Cuban says it will produce "the world's first trillionaires," but that should still leave plenty of money for regular investors who make the right trades early.
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Roche's (RHHBY) Influenza Drug Gets Positive CHMP Opinion
Roche (RHHBY - Free Report) announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of influenza drug Xofluza (baloxavir marboxil).
The drug is recommended for an approval to treat uncomplicated influenza in patients aged 12 years and above. In addition, the medicine recommended for a regulatory nod as a preventive treatment (post-exposure prophylaxis) of influenza in individuals aged 12 years and above.
The CHMP recommendation was based on the results of the phase III CAPSTONE-1, CAPSTONE-2 and BLOCKSTONE studies. A final decision regarding the approval is expected from the European Commission shortly.
Xofluza is approved in the United States for the treatment of acute, uncomplicated influenza in patients aged 12 years and above who are otherwise healthy or at high risk of developing serious complications from influenza and who have been symptomatic for not more than 48 hours. The product was the first new antiviral to be approved by the FDA in 20 years.
Concurrently, the CHMP also commended the approval of Phesgo, a fixed-dose combination of Perjeta (pertuzumab) and Herceptin (trastuzumab) with hyaluronidase, administered by a subcutaneous (under the skin) injection in combination with intravenous (IV) chemotherapy for the treatment of early and metastatic HER2-positive breast cancer.
Phesgo offers faster and less invasive delivery of the standard of care treatment with Perjeta and Herceptin under the skin in just a few minutes compared to hours with intravenous infusion. The FDA recently expedited the approval of Phesgo for the treatment of early and metastatic HER2-positive breast cancer.
The stock has gained 12.5% in the past year compared with the industry’s growth of 7.3%.
Growth in the newly-launched medicines, such as multiple sclerosis drug Ocrevus, hemophilia drug Hemlibra, immuno-oncology drug Tecentriq and breast cancer drug Perjeta was offset by the impact of biosimilar competition for older drugs and the COVID-19 pandemic.
Nevertheless, demand for Roche’s diagnostic tests should maintain the momentum.
Meanwhile, Roche entered into a partnership with Regeneron (REGN - Free Report) for its new antiviral antibody cocktail to fight COVID-19. Initial data showed that the REGNCOV2 antibody cocktail reduced the viral levels and improved symptoms in the non-hospitalized COVID-19 patients.
Roche currently carries a Zacks Rank #3 (Hold). Two better-ranked stocks in the healthcare space are Vanda Pharmaceuticals Inc. (VNDA - Free Report) and Cara Therapeutics, Inc. (CARA - Free Report) , both carrying a Zacks Rank #2 (Buy), presently. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Vanda’s earnings estimates have been raised 12 cents for 2020 in the past 30 days.
Cara’s loss estimates have narrowed 32 cents for 2020 in the past 30 days.
The Hottest Tech Mega-Trend of All
Last year, it generated $24 billion in global revenues. By 2020, it's predicted to blast through the roof to $77.6 billion. Famed investor Mark Cuban says it will produce "the world's first trillionaires," but that should still leave plenty of money for regular investors who make the right trades early.
See Zacks' 3 Best Stocks to Play This Trend >>