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Biotech Stock Roundup: MRNA COVID-19 Vaccine Update, Drug Approvals for ALKS, MYOV & More
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The biotech sector continues to be in focus with pipeline and regulatory updates. Drug approvals were in focus last week. The development of vaccines for COVID-19 also continues to be in focus, particularly for the younger population.
Recap of the Week’s Most Important Stories:
Biogen Announces Data on Actemra Biosimilar: Biogen (BIIB - Free Report) and its China-based partner Bio-Thera Solutions, Ltd. announced results from the late-stage study on a proposed biosimilar of arthritis drug, Actemra — BAT1806. The study met its primary endpoints, demonstrating equivalence to the reference drug, Actemra, in patients with moderate to severe rheumatoid arthritis (RA) inadequately controlled by methotrexate therapy. Actemra is approved for several indications — rheumatoid arthritis in adults and juvenile idiopathic polyarthritis, systemic juvenile idiopathic arthritis, giant cell arteritis and cytokine release syndrome.
Biogen has collaborated with Bio-Thera in April 2021 to develop, manufacture and commercialize BAT1806. Since the study met its primary endpoints, Biogen will make a payment of $30 million to Bio-Thera Solutions. Bio-Thera Solutions will be eligible to receive potential milestone payments if certain commercial milestones are achieved. Biogen will also pay Bio-Thera Solutions tiered royalties.
Moderna Initiates Rolling Submission of BLA for COVID-19 Vaccine: Moderna, Inc. (MRNA - Free Report) announced that it has initiated the rolling submission process with the FDA for a Biologics License Application (BLA) for the licensure of its mRNA COVID-19 vaccine to prevent COVID-19 in individuals 18 years of age and older.
The vaccine is currently authorized for use under an Emergency Use Authorization (EUA) by the FDA. Moderna will continue to submit data to support the BLA to the FDA on a rolling basis over the coming weeks, with a request for a Priority Review. Once the rolling BLA submission is completed, the FDA will notify the company when it is formally accepted for review.
Alkermes Gets FDA Nod for Schizophrenia Drug: Alkermes (ALKS - Free Report) announced that the FDA has approved Lybalvi (olanzapine and samidorphan) for the treatment of adults with schizophrenia as well as bipolar I disorder. The drug has been approved by the agency as a maintenance monotherapy or for the acute treatment of manic or mixed episodes, as monotherapy or an adjunct to lithium or valproate. Lybalvi is a once-daily, oral atypical antipsychotic composed of olanzapine, an established antipsychotic agent, and samidorphan, a new chemical entity. The FDA approved Lybalvi under the 505(b)(2) regulatory pathway based on data from 27 clinical studies. The data from the studies suggested that olanzapine-associated weight gain is disease-independent.
Myovant/Pfizer’s Drug Gets Approved: Myovant Sciences and partner Pfizer Inc. (PFE - Free Report) obtained FDA approval for Myfembree (relugolix 40 mg, estradiol 1 mg, and norethindrone acetate 0.5 mg). The drug has been approved as the first once-daily treatment for the management of heavy menstrual bleeding associated with uterine fibroids in premenopausal women, with a treatment duration of up to 24 months. Myfembree demonstrated 72.1% and 71.2% response rates in menstrual blood loss (MBL) at week 24, with MBL reductions of 82.0% and 84.3% from baseline in the phase III LIBERTY 1 and LIBERTY 2 studies, respectively. The companies will jointly commercialize the drug.
CureVac’s COVID-19 Vaccine Data Encouraging: CureVac N.V. (CVAC - Free Report) announced that its phase IIb/III study on COVID-19 vaccine candidate, CVnCoV, will continue following the first interim analysis in 59 eligible COVID-19 cases. The independent Data Safety Monitoring Board (DSMB) confirmed that the phase IIb/III study (HERALD) for CVnCoV has passed the first interim analysis in 59 adjudicated COVID-19 cases with no safety concerns. Consequently, the trial will continue to collect sufficient data in order to conduct a statistically significant efficacy analysis.
The HERALD study has enrolled approximately 40,000 participants in ten countries in Latin America and Europe. The primary objective of the study is to demonstrate the efficacy of a two-dose administration of 12µg of CVnCoV in preventing COVID-19 infection of any severity in participants without prior exposure to SARS-CoV-2. It is being conducted in an environment characterized by the spread of multiple virus strains. COVID-19 cases within the trial are currently being sequenced to provide critical complementary data to the efficacy readout.
Performance
Medical - Biomedical and Genetics Industry 5YR % Return
The Nasdaq Biotechnology Index gained 0.8% in the last four trading sessions. Among the biotech giants, Gilead lost 4.39% during the period. Over the past six months, shares of Alexion have surged 43.97%. (See the last biotech stock roundup here: Biotech Stock Roundup: MRNA's Vaccine Update & Pipeline Updates From REGN, BMY).
Image Source: Zacks Investment Research
What's Next in Biotech?
Stay tuned for more pipeline and regulatory updates.
Zacks Names “Single Best Pick to Double”
From thousands of stocks, 5 Zacks experts each have chosen their favorite to skyrocket +100% or more in months to come. From those 5, Director of Research Sheraz Mian hand-picks one to have the most explosive upside of all.
You know this company from its past glory days, but few would expect that it’s poised for a monster turnaround. Fresh from a successful repositioning and flush with A-list celeb endorsements, it could rival or surpass other recent Zacks’ Stocks Set to Double like Boston Beer Company which shot up +143.0% in a little more than 9 months and Nvidia which boomed +175.9% in one year.
Image: Bigstock
Biotech Stock Roundup: MRNA COVID-19 Vaccine Update, Drug Approvals for ALKS, MYOV & More
The biotech sector continues to be in focus with pipeline and regulatory updates. Drug approvals were in focus last week. The development of vaccines for COVID-19 also continues to be in focus, particularly for the younger population.
Recap of the Week’s Most Important Stories:
Biogen Announces Data on Actemra Biosimilar: Biogen (BIIB - Free Report) and its China-based partner Bio-Thera Solutions, Ltd. announced results from the late-stage study on a proposed biosimilar of arthritis drug, Actemra — BAT1806. The study met its primary endpoints, demonstrating equivalence to the reference drug, Actemra, in patients with moderate to severe rheumatoid arthritis (RA) inadequately controlled by methotrexate therapy. Actemra is approved for several indications — rheumatoid arthritis in adults and juvenile idiopathic polyarthritis, systemic juvenile idiopathic arthritis, giant cell arteritis and cytokine release syndrome.
Biogen has collaborated with Bio-Thera in April 2021 to develop, manufacture and commercialize BAT1806. Since the study met its primary endpoints, Biogen will make a payment of $30 million to Bio-Thera Solutions. Bio-Thera Solutions will be eligible to receive potential milestone payments if certain commercial milestones are achieved. Biogen will also pay Bio-Thera Solutions tiered royalties.
Biogen currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Moderna Initiates Rolling Submission of BLA for COVID-19 Vaccine: Moderna, Inc. (MRNA - Free Report) announced that it has initiated the rolling submission process with the FDA for a Biologics License Application (BLA) for the licensure of its mRNA COVID-19 vaccine to prevent COVID-19 in individuals 18 years of age and older.
The vaccine is currently authorized for use under an Emergency Use Authorization (EUA) by the FDA. Moderna will continue to submit data to support the BLA to the FDA on a rolling basis over the coming weeks, with a request for a Priority Review. Once the rolling BLA submission is completed, the FDA will notify the company when it is formally accepted for review.
Alkermes Gets FDA Nod for Schizophrenia Drug: Alkermes (ALKS - Free Report) announced that the FDA has approved Lybalvi (olanzapine and samidorphan) for the treatment of adults with schizophrenia as well as bipolar I disorder. The drug has been approved by the agency as a maintenance monotherapy or for the acute treatment of manic or mixed episodes, as monotherapy or an adjunct to lithium or valproate. Lybalvi is a once-daily, oral atypical antipsychotic composed of olanzapine, an established antipsychotic agent, and samidorphan, a new chemical entity. The FDA approved Lybalvi under the 505(b)(2) regulatory pathway based on data from 27 clinical studies. The data from the studies suggested that olanzapine-associated weight gain is disease-independent.
Myovant/Pfizer’s Drug Gets Approved: Myovant Sciences and partner Pfizer Inc. (PFE - Free Report) obtained FDA approval for Myfembree (relugolix 40 mg, estradiol 1 mg, and norethindrone acetate 0.5 mg). The drug has been approved as the first once-daily treatment for the management of heavy menstrual bleeding associated with uterine fibroids in premenopausal women, with a treatment duration of up to 24 months. Myfembree demonstrated 72.1% and 71.2% response rates in menstrual blood loss (MBL) at week 24, with MBL reductions of 82.0% and 84.3% from baseline in the phase III LIBERTY 1 and LIBERTY 2 studies, respectively. The companies will jointly commercialize the drug.
CureVac’s COVID-19 Vaccine Data Encouraging: CureVac N.V. (CVAC - Free Report) announced that its phase IIb/III study on COVID-19 vaccine candidate, CVnCoV, will continue following the first interim analysis in 59 eligible COVID-19 cases.
The independent Data Safety Monitoring Board (DSMB) confirmed that the phase IIb/III study (HERALD) for CVnCoV has passed the first interim analysis in 59 adjudicated COVID-19 cases with no safety concerns. Consequently, the trial will continue to collect sufficient data in order to conduct a statistically significant efficacy analysis.
The HERALD study has enrolled approximately 40,000 participants in ten countries in Latin America and Europe. The primary objective of the study is to demonstrate the efficacy of a two-dose administration of 12µg of CVnCoV in preventing COVID-19 infection of any severity in participants without prior exposure to SARS-CoV-2. It is being conducted in an environment characterized by the spread of multiple virus strains. COVID-19 cases within the trial are currently being sequenced to provide critical complementary data to the efficacy readout.
Performance
Medical - Biomedical and Genetics Industry 5YR % Return
Medical - Biomedical and Genetics Industry 5YR % Return
The Nasdaq Biotechnology Index gained 0.8% in the last four trading sessions. Among the biotech giants, Gilead lost 4.39% during the period. Over the past six months, shares of Alexion have surged 43.97%. (See the last biotech stock roundup here: Biotech Stock Roundup: MRNA's Vaccine Update & Pipeline Updates From REGN, BMY).
What's Next in Biotech?
Stay tuned for more pipeline and regulatory updates.
Zacks Names “Single Best Pick to Double”
From thousands of stocks, 5 Zacks experts each have chosen their favorite to skyrocket +100% or more in months to come. From those 5, Director of Research Sheraz Mian hand-picks one to have the most explosive upside of all.
You know this company from its past glory days, but few would expect that it’s poised for a monster turnaround. Fresh from a successful repositioning and flush with A-list celeb endorsements, it could rival or surpass other recent Zacks’ Stocks Set to Double like Boston Beer Company which shot up +143.0% in a little more than 9 months and Nvidia which boomed +175.9% in one year.
Free: See Our Top Stock and 4 Runners Up >>