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Roche's Flu Drug Meets Primary Endpoint in Phase III Study
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Roche (RHHBY - Free Report) announced that the phase III study, CAPSTONE-2, on an investigational oral, single-dose antiviral candidate, baloxavir marboxil, met the primary endpoint.
The phase III, multicentre, randomised, double-blind study is evaluating the safety and efficacy of baloxavir marboxil in patients suffering from risk of complications from the flu. Participants enrolled in the study were randomly assigned to receive a single dose of 40 mg or 80 mg of baloxavir marboxil (according to body weight), placebo or 75 mg of oseltamivir twice a day for 5 days.
Baloxavir marboxil showed superior efficacy in the primary endpoint of the time to improve influenza symptoms versus placebo.
The candidate also showed superior efficacy compared to placebo and oseltamivir for important secondary endpoints, including reducing the time that the virus continued to be released (viral shedding) and reducing viral levels in the body. Moreover, baloxavir marboxil significantly reduced the incidence of influenza-related complications compared to placebo.
Roche expects to present full results from the study at an upcoming medical meeting.
We remind investors that Baloxavir marboxil was discovered and developed by Shionogi & Co., Ltd., and is marketed in Japan under the trade name Xofluza. Per the terms of the agreement between Roche and Shionogi, Roche holds worldwide rights to baloxavir marboxil excluding Japan and Taiwan, which will be retained exclusively by Shionogi & Co., Ltd.
Last month, the FDA accepted Roche’s new drug application (NDA) and granted priority review for baloxavir marboxil as a single-dose, oral treatment for acute, uncomplicated influenza in patients aged 12 years and older.
A decision is expected by Dec 24, 2018. Per the company, assuming approval, baloxavir marboxil would be the first single-dose oral antiviral, and also the first medicine with a novel proposed mechanism of action to treat the flu in nearly 20 years.
A tentative approval bodes well for Roche, given the huge market, as influenza is one of the most common, yet serious, infectious diseases with annual epidemics resulting in 3 to 5 million cases of severe disease, millions of hospitalizations and up to 650,000 deaths worldwide on a global basis.
Roche also plans to evaluate the candidate in paediatric and severely ill hospitalized patients with influenza.
Roche, a leader in the oncology space, is looking to expand its portfolio beyond oncology.
Year to date, shares of Roche have declined 5% against the industry’s gain of 0.5%. Roche’s legacy drugs like Herceptin and MabThera are facing competition from biosimilars. Novartis (NVS - Free Report) has already launched its biosimilar version of Rituxan/ MabThera in Europe. Amgen (AMGN - Free Report) also obtained FDA approval for a biosimilar version of Avastin for treatment of cancers. Sales of Tarceva continue to decline.
Alexion’s shares have gained 12.6% this year so far.
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Roche's Flu Drug Meets Primary Endpoint in Phase III Study
Roche (RHHBY - Free Report) announced that the phase III study, CAPSTONE-2, on an investigational oral, single-dose antiviral candidate, baloxavir marboxil, met the primary endpoint.
The phase III, multicentre, randomised, double-blind study is evaluating the safety and efficacy of baloxavir marboxil in patients suffering from risk of complications from the flu. Participants enrolled in the study were randomly assigned to receive a single dose of 40 mg or 80 mg of baloxavir marboxil (according to body weight), placebo or 75 mg of oseltamivir twice a day for 5 days.
Baloxavir marboxil showed superior efficacy in the primary endpoint of the time to improve influenza symptoms versus placebo.
The candidate also showed superior efficacy compared to placebo and oseltamivir for important secondary endpoints, including reducing the time that the virus continued to be released (viral shedding) and reducing viral levels in the body. Moreover, baloxavir marboxil significantly reduced the incidence of influenza-related complications compared to placebo.
Roche expects to present full results from the study at an upcoming medical meeting.
We remind investors that Baloxavir marboxil was discovered and developed by Shionogi & Co., Ltd., and is marketed in Japan under the trade name Xofluza. Per the terms of the agreement between Roche and Shionogi, Roche holds worldwide rights to baloxavir marboxil excluding Japan and Taiwan, which will be retained exclusively by Shionogi & Co., Ltd.
Last month, the FDA accepted Roche’s new drug application (NDA) and granted priority review for baloxavir marboxil as a single-dose, oral treatment for acute, uncomplicated influenza in patients aged 12 years and older.
A decision is expected by Dec 24, 2018. Per the company, assuming approval, baloxavir marboxil would be the first single-dose oral antiviral, and also the first medicine with a novel proposed mechanism of action to treat the flu in nearly 20 years.
A tentative approval bodes well for Roche, given the huge market, as influenza is one of the most common, yet serious, infectious diseases with annual epidemics resulting in 3 to 5 million cases of severe disease, millions of hospitalizations and up to 650,000 deaths worldwide on a global basis.
Roche also plans to evaluate the candidate in paediatric and severely ill hospitalized patients with influenza.
Roche, a leader in the oncology space, is looking to expand its portfolio beyond oncology.
Year to date, shares of Roche have declined 5% against the industry’s gain of 0.5%. Roche’s legacy drugs like Herceptin and MabThera are facing competition from biosimilars. Novartis (NVS - Free Report) has already launched its biosimilar version of Rituxan/ MabThera in Europe. Amgen (AMGN - Free Report) also obtained FDA approval for a biosimilar version of Avastin for treatment of cancers. Sales of Tarceva continue to decline.
Zacks Rank & Stock to Consider
Roche currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the pharma/biotech sector is Alexion Pharmaceuticals , which carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Alexion’s shares have gained 12.6% this year so far.
Today's Stocks from Zacks' Hottest Strategies
It's hard to believe, even for us at Zacks. But while the market gained +21.9% in 2017, our top stock-picking screens have returned +115.0%, +109.3%, +104.9%, +98.6%, and +67.1%.
And this outperformance has not just been a recent phenomenon. Over the years it has been remarkably consistent. From 2000 - 2017, the composite yearly average gain for these strategies has beaten the market more than 19X over. Maybe even more remarkable is the fact that we're willing to share their latest stocks with you without cost or obligation.
See Them Free>>