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Biotech Stock Roundup: Drug Approvals for BMRN, Updates From BIIB, BMY, MRNA & More
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While updates on coronavirus treatments continue to be in the spotlight, the biotech sector has been 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’s AD drug Gets Negative Trend Vote: Biogen (BIIB - Free Report) and its Japan-based partner Eisai announced that they obtained a negative trend vote on the marketing authorization application for their Alzheimer’s disease drug aducanumab from the Committee for Medicinal Products for Human Use (“CHMP”) of the European Medicines Agency (“EMA”). The negative trend vote follows an oral explanation by Biogen at a meeting held earlier this month. The CHMP is expected to adopt a formal opinion next month, and it will most likely stand by the negative vote. Biogen continues to engage with the EMA and CHMP for the same. Aducanumab is marketed as Aduhlem for the treatment of Alzheimer’s disease in the United States.
Regulatory and Pipeline Updates From Bristol Myers: Bristol Myers Squibb (BMY - Free Report) recently announced the European Commission (“EC”) has approved a label expansion of Zeposia (ozanimod) for the treatment of adults with moderately to severely active ulcerative colitis (UC) who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic agent. Zeposia is already approved in this region for the treatment of adult patients with relapsing remitting multiple sclerosis (RRMS) with active disease.
Bristol Myers also announced that the FDA has extended the review of the new drug application (NDA) for cardiovascular candidate mavacamten. Mavacamten is being evaluated for the treatment of patients with symptomatic obstructive hypertrophic cardiomyopathy (oHCM), the most common inherited heart disease. The regulatory body was initially slated to give a decision on Jan 28, 2022. However, it notified Bristol Myers that the target action date has been extended to Apr 28, 2022.
The agency requires additional time to review information pertaining to updates to the proposed Risk Evaluation Mitigation Strategy (REMS). While the delay in a tentative approval was disappointing, on a positive note, the FDA did not ask for additional data from Bristol Myers.
BioMarin's Drug Approval: Shares of BioMarin Pharmaceutical Inc. (BMRN - Free Report) gained after the company won FDA approval for Voxzogo for achondroplasia, the most common form of dwarfism. The FDA granted accelerated approval to Voxzogo injection to increase linear growth in pediatric patients with achondroplasia five years of age and older with open epiphyses (growth plates). This indication is approved under accelerated approval based on an improvement in annualized growth velocity. BioMarin plans to use the ongoing open-label extension studies compared to available natural history to fulfill the post-marketing requirement of continued approval.
Voxzogo, a C-type natriuretic peptide (CNP) analog, represents a new class of therapy, which acts as a positive regulator of the signaling pathway downstream of FGFR3 to promote endochondral bone growth. The approval is a significant boost to BioMarin’s prospects.
Moderna Gets FDA Authorization for Booster Dose: Moderna, Inc. (MRNA - Free Report) announced that the FDA has extended the emergency use authorization of a booster dose of its mRNA-based COVID-19 vaccine at the 50 µg dose level to all adults aged 18 and older. The booster dose can be given to all individuals 18 years and older who have completed a primary vaccination with any other authorized or approved COVID-19 vaccine. The booster shot is to be administered at least six months after completing any primary series COVID-19 vaccination.
Last month, the FDA authorized for emergency use a booster dose of Moderna’s COVID-19 vaccine at the 50 µg dose level for people aged 65 and older as well as adults aged 18 to 64 who are at high risk of severe COVID-19, and people aged 18 to 64 with frequent institutional or occupational exposure to SARS-CoV-2.
Updates from Gilead: Gilead Sciences, Inc. (GILD - Free Report) recently announced that the EC has granted marketing authorization to its breast cancer drug Trodelvy (sacituzumab govitecan). The drug, a first-in-class Trop-2-directed antibody-drug conjugate, has been approved as a monotherapy indicated for treating adult patients with unresectable or metastatic triple-negative breast cancer (TNBC) who have received two or more prior systemic therapies, at least one of them for advanced disease. The marketing authorization for Gilead’s Trodelvy was based on results of the phase III ASCENT study, which showed that Trodelvy significantly improved overall survival versus physician’s choice of chemotherapy in this indication.
Gilead has also submitted a BLA to the FDA for bulevirtide for injection (2 mg), a potential first-in-class antiviral medicine for the treatment of chronic hepatitis delta virus (HDV) infection in adults with compensated liver disease.
Performance
Medical - Biomedical and Genetics Industry 5YR % Return
The Nasdaq Biotechnology Index has lost 0.96% in the past five trading sessions. Among the biotech giants, Moderna has gained 17.97% during the period. Over the past six months, shares of Moderna have soared 68.35%. (See the last biotech stock roundup here: Biotech Stock Roundup: REGN Gets EC Nod for Cocktail, BIIB’s Drug Approval & More).
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What's Next in Biotech?
Stay tuned for more pipeline and regulatory updates.
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Biotech Stock Roundup: Drug Approvals for BMRN, Updates From BIIB, BMY, MRNA & More
While updates on coronavirus treatments continue to be in the spotlight, the biotech sector has been 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’s AD drug Gets Negative Trend Vote: Biogen (BIIB - Free Report) and its Japan-based partner Eisai announced that they obtained a negative trend vote on the marketing authorization application for their Alzheimer’s disease drug aducanumab from the Committee for Medicinal Products for Human Use (“CHMP”) of the European Medicines Agency (“EMA”). The negative trend vote follows an oral explanation by Biogen at a meeting held earlier this month. The CHMP is expected to adopt a formal opinion next month, and it will most likely stand by the negative vote. Biogen continues to engage with the EMA and CHMP for the same. Aducanumab is marketed as Aduhlem for the treatment of Alzheimer’s disease in the United States.
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 and Pipeline Updates From Bristol Myers: Bristol Myers Squibb (BMY - Free Report) recently announced the European Commission (“EC”) has approved a label expansion of Zeposia (ozanimod) for the treatment of adults with moderately to severely active ulcerative colitis (UC) who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic agent. Zeposia is already approved in this region for the treatment of adult patients with relapsing remitting multiple sclerosis (RRMS) with active disease.
Bristol Myers also announced that the FDA has extended the review of the new drug application (NDA) for cardiovascular candidate mavacamten. Mavacamten is being evaluated for the treatment of patients with symptomatic obstructive hypertrophic cardiomyopathy (oHCM), the most common inherited heart disease. The regulatory body was initially slated to give a decision on Jan 28, 2022. However, it notified Bristol Myers that the target action date has been extended to Apr 28, 2022.
The agency requires additional time to review information pertaining to updates to the proposed Risk Evaluation Mitigation Strategy (REMS). While the delay in a tentative approval was disappointing, on a positive note, the FDA did not ask for additional data from Bristol Myers.
BioMarin's Drug Approval: Shares of BioMarin Pharmaceutical Inc. (BMRN - Free Report) gained after the company won FDA approval for Voxzogo for achondroplasia, the most common form of dwarfism. The FDA granted accelerated approval to Voxzogo injection to increase linear growth in pediatric patients with achondroplasia five years of age and older with open epiphyses (growth plates). This indication is approved under accelerated approval based on an improvement in annualized growth velocity. BioMarin plans to use the ongoing open-label extension studies compared to available natural history to fulfill the post-marketing requirement of continued approval.
Voxzogo, a C-type natriuretic peptide (CNP) analog, represents a new class of therapy, which acts as a positive regulator of the signaling pathway downstream of FGFR3 to promote endochondral bone growth. The approval is a significant boost to BioMarin’s prospects.
Moderna Gets FDA Authorization for Booster Dose: Moderna, Inc. (MRNA - Free Report) announced that the FDA has extended the emergency use authorization of a booster dose of its mRNA-based COVID-19 vaccine at the 50 µg dose level to all adults aged 18 and older. The booster dose can be given to all individuals 18 years and older who have completed a primary vaccination with any other authorized or approved COVID-19 vaccine. The booster shot is to be administered at least six months after completing any primary series COVID-19 vaccination.
Last month, the FDA authorized for emergency use a booster dose of Moderna’s COVID-19 vaccine at the 50 µg dose level for people aged 65 and older as well as adults aged 18 to 64 who are at high risk of severe COVID-19, and people aged 18 to 64 with frequent institutional or occupational exposure to SARS-CoV-2.
Updates from Gilead: Gilead Sciences, Inc. (GILD - Free Report) recently announced that the EC has granted marketing authorization to its breast cancer drug Trodelvy (sacituzumab govitecan). The drug, a first-in-class Trop-2-directed antibody-drug conjugate, has been approved as a monotherapy indicated for treating adult patients with unresectable or metastatic triple-negative breast cancer (TNBC) who have received two or more prior systemic therapies, at least one of them for advanced disease. The marketing authorization for Gilead’s Trodelvy was based on results of the phase III ASCENT study, which showed that Trodelvy significantly improved overall survival versus physician’s choice of chemotherapy in this indication.
Gilead has also submitted a BLA to the FDA for bulevirtide for injection (2 mg), a potential first-in-class antiviral medicine for the treatment of chronic hepatitis delta virus (HDV) infection in adults with compensated liver disease.
Performance
Medical - Biomedical and Genetics Industry 5YR % Return
Medical - Biomedical and Genetics Industry 5YR % Return
The Nasdaq Biotechnology Index has lost 0.96% in the past five trading sessions. Among the biotech giants, Moderna has gained 17.97% during the period. Over the past six months, shares of Moderna have soared 68.35%. (See the last biotech stock roundup here: Biotech Stock Roundup: REGN Gets EC Nod for Cocktail, BIIB’s Drug Approval & More).
What's Next in Biotech?
Stay tuned for more pipeline and regulatory updates.