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Biotech Stock Roundup: Regulatory Updates From BIIB, AMGN and NVAX & More
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While updates on COVID-19 vaccines and treatments remain in the spotlight amid the rapidly spreading Omicron variant, the biotech sector was also in focus over the past week with drug approvals, label expansion of existing drugs and other regular pipeline updates.
Recap of the Week’s Most Important Stories:
Biogen Slashes AD Drug Price, Other Updates: Biogen (BIIB - Free Report) recently announced that it will lower the price of its Alzheimer’s Disease (AD) drug Aduhelm (aducanumab-avwa) in a move to increase patient access. The biotech giant stated that it will reduce the wholesale acquisition cost (WAC) of Aduhelm 100 mg/mL injection for intravenous use in the United States by approximately 50%. The price reduction becomes effective Jan 1, 2022. The approval of its AD drug in mid-2021 boosted Biogen, but the launch of Aduhelm has been slow due to limited patient access. The high cost of the drug has been a deterrent.
Biogen also announced that it will implement a series of cost-reduction measures next year to better align its costs with its revenue base, which is expected to be impacted by the continued entry of generics in multiple sclerosis and the delayed uptake of Aduhelm. The measures are estimated to yield approximately $500 million in annualized savings, a significant portion of which will be realized in 2022.
Separately, Biogen and partner Eisai Co announced that they plan to submit the final protocols for the phase IV post-marketing confirmatory study of Aduhelm (aducanumab) in AD for review to the FDA in March 2022. The patient screening will be initiated in May 2022. The study is a post-marketing requirement of the FDA’s accelerated approval.
The Committee for Medicinal Products for Human Use (“CHMP”) of the European Medicines Agency has adopted a negative opinion on the marketing authorization application (MAA) for aducanumab for the treatment of the early stages of AD.
Regulatory Updates From Amgen: Amgen (AMGN - Free Report) announced that the FDA has approved Tezspire (tezepelumab-ekko) for the add-on maintenance treatment of adult and pediatric patients aged 12 years and older with severe asthma. Amgen is developing Tezspire in collaboration with AstraZeneca. The approval was based on positive data from the PATHFINDER clinical program and included the phase III NAVIGATOR study. Data from these studies showed that treatment with Tezspire led to superior results across every primary and key secondary endpoint in patients with severe asthma compared to placebo, when added to standard therapy. Per Amgen and AstraZeneca, Tezspire is the first and only biologic to consistently and significantly reduce exacerbations in a broad population of severe asthma patients and indicated for severe asthma that does not have a phenotype—eosinophilic or allergic—or biomarker limitation within its approved label. The drug is under regulatory review in the EU, Japan and several other countries worldwide.
Vir’s Treatment Gets Approval: Vir Biotechnology, Inc. (VIR - Free Report) and partner GlaxoSmithKline announced that the European Commission (“EC”) has granted marketing authorization to sotrovimab for the early treatment of COVID-19 under the brand name Xevudy. It is now approved in the European Union (“EU”) for the treatment of adults and adolescents (aged 12 years and over and weighing at least 40kg) with COVID-19 who do not require supplemental oxygen and are at increased risk of progressing to severe COVID-19.
The approval was based on positive data from the phase III study, COMET-ICE, which demonstrated that intravenous treatment with sotrovimab resulted in a 79% reduction (adjusted relative risk reduction) in all-cause hospitalizations for more than 24 hours or death due to any cause by day 29 compared to placebo. Vir and Glaxo had earlier reported preclinical data, which showed that sotrovimab retains activity against the rapidly spreading Omicron variant and all other currently tested variants of concern and interest.
Gilead’s HIV Study on Hold: Gilead Sciences, Inc. (GILD - Free Report) announced that the FDA has placed a clinical hold on the use of injectable lenacapavir in borosilicate vials in all ongoing clinical studies for HIV treatment and HIV pre-exposure prophylaxis (PrEP). The regulatory body placed the hold due to emerging concerns about the compatibility of vials made of borosilicate glass with lenacapavir solution. This could potentially lead to the formation of sub-visible glass particles in the solution of lenacapavir. Nevertheless, dosing of oral formulations of lenacapavir will continue.
Gilead also announced that the EC has expanded the label for antiviral Veklury (remdesivir) for use at the early stages of COVID-19 to help prevent disease progression in high-risk patients in the EU.
Veklury can now be used for adults who do not require supplemental oxygen and are at an increased risk of progressing to severe COVID-19. It was previously granted authorization to treat COVID-19 in adults and adolescents (aged 12 to less than 18 years and weighing at least 40 kg) with pneumonia requiring supplemental oxygen (low- or high-flow oxygen or other non-invasive ventilation at the start of the treatment). This expanded indication follows the positive recommendation of the CHMP for Veklury on Dec 16 amid rising COVID-19 cases and the emergence of new variants like Omicron.
Updates From Novavax: Novavax, Inc. (NVAX - Free Report) announced that the EC has granted conditional marketing authorization to its COVID-19 vaccine Nuvaxovid (recombinant, adjuvanted) for active immunization to prevent COVID-19 in individuals 18 years of age and older.
The World Health Organization has also granted a second emergency use listing (EUL) for NVX-CoV2373 for the prevention of COVID-19 in individuals 18 years of age and older.
Novavax also announced the first booster doses of NVX-CoV2373 have been administered in an extension of its phase III study, PREVENT-19. The study will evaluate the safety and efficacy of a heterologous or homologous third dose of NVX-CoV2373.
Performance
Medical - Biomedical and Genetics Industry 5YR % Return
Image: Bigstock
Biotech Stock Roundup: Regulatory Updates From BIIB, AMGN and NVAX & More
While updates on COVID-19 vaccines and treatments remain in the spotlight amid the rapidly spreading Omicron variant, the biotech sector was also in focus over the past week with drug approvals, label expansion of existing drugs and other regular pipeline updates.
Recap of the Week’s Most Important Stories:
Biogen Slashes AD Drug Price, Other Updates: Biogen (BIIB - Free Report) recently announced that it will lower the price of its Alzheimer’s Disease (AD) drug Aduhelm (aducanumab-avwa) in a move to increase patient access. The biotech giant stated that it will reduce the wholesale acquisition cost (WAC) of Aduhelm 100 mg/mL injection for intravenous use in the United States by approximately 50%. The price reduction becomes effective Jan 1, 2022. The approval of its AD drug in mid-2021 boosted Biogen, but the launch of Aduhelm has been slow due to limited patient access. The high cost of the drug has been a deterrent.
Biogen also announced that it will implement a series of cost-reduction measures next year to better align its costs with its revenue base, which is expected to be impacted by the continued entry of generics in multiple sclerosis and the delayed uptake of Aduhelm. The measures are estimated to yield approximately $500 million in annualized savings, a significant portion of which will be realized in 2022.
Separately, Biogen and partner Eisai Co announced that they plan to submit the final protocols for the phase IV post-marketing confirmatory study of Aduhelm (aducanumab) in AD for review to the FDA in March 2022. The patient screening will be initiated in May 2022. The study is a post-marketing requirement of the FDA’s accelerated approval.
The Committee for Medicinal Products for Human Use (“CHMP”) of the European Medicines Agency has adopted a negative opinion on the marketing authorization application (MAA) for aducanumab for the treatment of the early stages of AD.
Biogen currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Regulatory Updates From Amgen: Amgen (AMGN - Free Report) announced that the FDA has approved Tezspire (tezepelumab-ekko) for the add-on maintenance treatment of adult and pediatric patients aged 12 years and older with severe asthma. Amgen is developing Tezspire in collaboration with AstraZeneca. The approval was based on positive data from the PATHFINDER clinical program and included the phase III NAVIGATOR study. Data from these studies showed that treatment with Tezspire led to superior results across every primary and key secondary endpoint in patients with severe asthma compared to placebo, when added to standard therapy. Per Amgen and AstraZeneca, Tezspire is the first and only biologic to consistently and significantly reduce exacerbations in a broad population of severe asthma patients and indicated for severe asthma that does not have a phenotype—eosinophilic or allergic—or biomarker limitation within its approved label. The drug is under regulatory review in the EU, Japan and several other countries worldwide.
Vir’s Treatment Gets Approval: Vir Biotechnology, Inc. (VIR - Free Report) and partner GlaxoSmithKline announced that the European Commission (“EC”) has granted marketing authorization to sotrovimab for the early treatment of COVID-19 under the brand name Xevudy. It is now approved in the European Union (“EU”) for the treatment of adults and adolescents (aged 12 years and over and weighing at least 40kg) with COVID-19 who do not require supplemental oxygen and are at increased risk of progressing to severe COVID-19.
The approval was based on positive data from the phase III study, COMET-ICE, which demonstrated that intravenous treatment with sotrovimab resulted in a 79% reduction (adjusted relative risk reduction) in all-cause hospitalizations for more than 24 hours or death due to any cause by day 29 compared to placebo.
Vir and Glaxo had earlier reported preclinical data, which showed that sotrovimab retains activity against the rapidly spreading Omicron variant and all other currently tested variants of concern and interest.
Gilead’s HIV Study on Hold: Gilead Sciences, Inc. (GILD - Free Report) announced that the FDA has placed a clinical hold on the use of injectable lenacapavir in borosilicate vials in all ongoing clinical studies for HIV treatment and HIV pre-exposure prophylaxis (PrEP). The regulatory body placed the hold due to emerging concerns about the compatibility of vials made of borosilicate glass with lenacapavir solution. This could potentially lead to the formation of sub-visible glass particles in the solution of lenacapavir. Nevertheless, dosing of oral formulations of lenacapavir will continue.
Gilead also announced that the EC has expanded the label for antiviral Veklury (remdesivir) for use at the early stages of COVID-19 to help prevent disease progression in high-risk patients in the EU.
Veklury can now be used for adults who do not require supplemental oxygen and are at an increased risk of progressing to severe COVID-19. It was previously granted authorization to treat COVID-19 in adults and adolescents (aged 12 to less than 18 years and weighing at least 40 kg) with pneumonia requiring supplemental oxygen (low- or high-flow oxygen or other non-invasive ventilation at the start of the treatment). This expanded indication follows the positive recommendation of the CHMP for Veklury on Dec 16 amid rising COVID-19 cases and the emergence of new variants like Omicron.
Updates From Novavax: Novavax, Inc. (NVAX - Free Report) announced that the EC has granted conditional marketing authorization to its COVID-19 vaccine Nuvaxovid (recombinant, adjuvanted) for active immunization to prevent COVID-19 in individuals 18 years of age and older.
The World Health Organization has also granted a second emergency use listing (EUL) for NVX-CoV2373 for the prevention of COVID-19 in individuals 18 years of age and older.
Novavax also announced the first booster doses of NVX-CoV2373 have been administered in an extension of its phase III study, PREVENT-19. The study will evaluate the safety and efficacy of a heterologous or homologous third dose of NVX-CoV2373.
Performance
Medical - Biomedical and Genetics Industry 5YR % Return
The Nasdaq Biotechnology Index has gained 3.55% in the past five trading sessions. Among the biotech giants, Incyte has gained 7.42% during the period. Over the past six months, shares of Moderna have soared 28.76%. (See the last biotech stock roundup here: Biotech Stock Roundup: Biotech Stock Roundup: BMY Increases Dividend, MRNA’s Study Results & More)
What's Next in Biotech?
Stay tuned for more pipeline and regulatory updates.