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Roche (RHHBY) Stops Dosing in Huntington's Disease Study
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Roche Holding AG (RHHBY - Free Report) announced that it has decided to discontinue dosing in the phase III study evaluating its pipeline candidate, tominersen, in manifest Huntington’s disease (“HD”).
The decision was taken based on results of a pre-planned review of data from the phase III GENERATION HD1 study, which was conducted by Independent Data Monitoring Committee (iDMC).
Though no new safety signal was observed for tominersen in iDMC’s review, the iDMC gave its recommendation to stop dosing in the study, based on the candidate’s potential benefit/risk profile for study participants.
Meanwhile, dosing will also be paused in the open-label extension study (GEN-EXTEND) of tominersen but the phase I PK/PD study (GEN-PEAK) of tominersen and the observational Roche HD natural history study on the same will continue.
Shares of Roche have declined 3.1% so far this year compared with the industry’s decrease of 1.1%.
We remind investors that Roche licensed tominersen from Ionis Pharmaceuticals (IONS - Free Report) in December 2017. Ionis is eligible to receive milestone payments and royalties on sales of tominersen if the medicine is approved. Shares of Ionis were down in after-hours trading on Monday following the above-mentioned news.
Notably, Huntington’s disease is a progressive brain disorder that causes the nerve cells in the brain to break down. Currently, there is no approved therapy that can treat the underlying cause of HD.
Apart from HD, Roche is evaluating several medicines for addressing various neurological disorders. The company is looking to develop medicines for treating multiple sclerosis, spinal muscular atrophy, neuromyelitis optica spectrum disorder, Alzheimer’s disease, Parkinson’s disease, Duchenne muscular dystrophy and autism spectrum disorder.
In a separate press release, Roche and partner Regeneron (REGN - Free Report) announced positive top-line results from a phase III study evaluating their antibody cocktail of casirivimab and imdevimab in non-hospitalized COVID-19 patients.
The study met the primary endpoint by demonstrating that the cocktail therapy significantly reduced the risk of hospitalization or death by 70%. The combo therapy also significantly shortened the duration of symptoms by four days.
Please note that casirivimab and imdevimab is a cocktail of two monoclonal antibodies (also known as REGN10933 and REGN10987, respectively), and was specifically developed by Regeneron to block the infectivity of SARS-CoV-2 — the virus that causes COVID-19.
In November 2020, the antibody cocktail was granted an Emergency Use Authorization by the FDA for the treatment of mild-to-moderate COVID-19 infection in patients who are at high risk of progressing to severe COVID-19 and/or hospitalization.
Notably, in 2020, Roche entered into a number of new partnerships with Regeneron, Gilead (GILD - Free Report) and Atea, to develop, manufacture and distribute molecules that can potentially both treat and prevent COVID-19.
Zacks Rank
Roche currently carries a Zacks Rank #5 (Strong Sell).
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 (RHHBY) Stops Dosing in Huntington's Disease Study
Roche Holding AG (RHHBY - Free Report) announced that it has decided to discontinue dosing in the phase III study evaluating its pipeline candidate, tominersen, in manifest Huntington’s disease (“HD”).
The decision was taken based on results of a pre-planned review of data from the phase III GENERATION HD1 study, which was conducted by Independent Data Monitoring Committee (iDMC).
Though no new safety signal was observed for tominersen in iDMC’s review, the iDMC gave its recommendation to stop dosing in the study, based on the candidate’s potential benefit/risk profile for study participants.
Meanwhile, dosing will also be paused in the open-label extension study (GEN-EXTEND) of tominersen but the phase I PK/PD study (GEN-PEAK) of tominersen and the observational Roche HD natural history study on the same will continue.
Shares of Roche have declined 3.1% so far this year compared with the industry’s decrease of 1.1%.
We remind investors that Roche licensed tominersen from Ionis Pharmaceuticals (IONS - Free Report) in December 2017. Ionis is eligible to receive milestone payments and royalties on sales of tominersen if the medicine is approved. Shares of Ionis were down in after-hours trading on Monday following the above-mentioned news.
Notably, Huntington’s disease is a progressive brain disorder that causes the nerve cells in the brain to break down. Currently, there is no approved therapy that can treat the underlying cause of HD.
Apart from HD, Roche is evaluating several medicines for addressing various neurological disorders. The company is looking to develop medicines for treating multiple sclerosis, spinal muscular atrophy, neuromyelitis optica spectrum disorder, Alzheimer’s disease, Parkinson’s disease, Duchenne muscular dystrophy and autism spectrum disorder.
In a separate press release, Roche and partner Regeneron (REGN - Free Report) announced positive top-line results from a phase III study evaluating their antibody cocktail of casirivimab and imdevimab in non-hospitalized COVID-19 patients.
The study met the primary endpoint by demonstrating that the cocktail therapy significantly reduced the risk of hospitalization or death by 70%. The combo therapy also significantly shortened the duration of symptoms by four days.
Please note that casirivimab and imdevimab is a cocktail of two monoclonal antibodies (also known as REGN10933 and REGN10987, respectively), and was specifically developed by Regeneron to block the infectivity of SARS-CoV-2 — the virus that causes COVID-19.
In November 2020, the antibody cocktail was granted an Emergency Use Authorization by the FDA for the treatment of mild-to-moderate COVID-19 infection in patients who are at high risk of progressing to severe COVID-19 and/or hospitalization.
Notably, in 2020, Roche entered into a number of new partnerships with Regeneron, Gilead (GILD - Free Report) and Atea, to develop, manufacture and distribute molecules that can potentially both treat and prevent COVID-19.
Zacks Rank
Roche currently carries a Zacks Rank #5 (Strong Sell).
You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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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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