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Pharma Stock Roundup: Approval of PFE/BNTX Coronavirus Vaccine in UK, Other Updates
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This week, Pfizer (PFE - Free Report) and BioNTech’s (BNTX - Free Report) COVID-19 vaccine won approval in the United Kingdom. The companies also filed a formal marketing application with the European Medicines Agency (EMA) for their COVID-19 vaccine. Meanwhile, FDA approved Roche (RHHBY - Free Report) injectable biologic medicine, Xolair for its third indication.
Recap of the Week’s Most Important Stories
Pfizer/BioNTech’s BNT162b2 Gets Approved in United Kingdom: Pfizer/BioNTech’s mRNA-based coronavirus vaccine, BNT162b2 got its first approval in the world. The U.K. regulatory agency, Medicines & Healthcare Products Regulatory Agency (MHRA) granted it a temporary authorization for emergency use. The companies are ready to distribute the first doses in the U.K. immediately. Earlier, the companies had signed an agreement to supply a total of 40 million doses to the U.K. in 2020/2021.
The companies also applied for conditional marketing authorization (CMA) to the European Medicines Agency (EMA) for BNT162b2. In response to the CMA filing, the EMA said that its Committee for Human Medicines (CHMP) will review the quality, safety and effectiveness of the vaccine and will conclude its assessment by a meeting scheduled for Dec 29. The European Commission, the EU executive body, will give its final decision days after a recommendation by the EMA.
FDA Approves Roche’s Xolair for Third Indication: The FDA granted approval to Roche’s Xolair for the treatment of nasal polyps (in adult patients) that targets and blocks immunoglobulin E (IgE), a key driver of inflammation. Xolair is already approved for moderate-to-severe persistent allergic asthma for patients 6 years of age or older and chronic idiopathic urticaria (CIU) in people 12 years of age and older
Lilly to Supply More Bamlanivimab Doses to U.S. Government: Lilly (LLY - Free Report) signed a deal with the U.S. government to supply 6,50,000 doses of its antibody drug bamlanivimab (LY-CoV555), which was granted Emergency Use Authorization (EUA) by the FDA last month to treat recently diagnosed mild-to-moderate COVID-19 illness at high risk of progressing to severe COVID-19 or hospitalization. The doses will be delivered through Jan 31, 2021. However, Lilly will deliver at least 3,50,000 doses this month. The purchase deal is worth $812.5 million. With the latest purchase, the U.S. government has now purchased a total of 9,50,000 doses of bamlanivimab from Lilly.
AbbVie’s New R&D Partnership Deal:AbbVie (ABBV - Free Report) signed a multi-year collaboration deal with precision medicines company, Frontier Medicines, Corp. to discover and develop innovative small molecule programs directed against E3 ligase, immunology and oncology targets, which can be developed into highly differentiated and efficacious therapeutics. For the deal, AbbVie will make an upfront payment of $55 million to Frontier while the latter will be entitled to receive additional milestone payments.
J&J Files BLA for Lung Cancer Candidate: J&J (JNJ - Free Report) filed a biologics license application (BLA) seeking approval for amivantamab for treating patients with EGFR-mutated non-small cell lung cancer (NSCLC). The BLA submission for amivantamab is based on data from the monotherapy arm of the phase I CHRYSALIS study, which evaluated amivantamab as a monotherapy as well as in combination with third-generation tyrosine-kinase inhibitor (TKI) lazertinib in advanced NSCLC.
J&J acquired rights to an investigational gene therapy candidate, HMR59 from private biotech, Hemera Biosciences, being developed for late-stage age-related macular degeneration. The acquisition expands J&J’s eye disease portfolio and strengthens its gene therapy capabilities. Financial terms of the deal have not been disclosed.
Japan Approval for AstraZeneca’s Forxiga for Heart Failure: AstraZeneca’s (AZN - Free Report) Forxiga was approved in Japan for the treatment of chronic heart failure with reduced ejection fraction (HFrEF) in adults with and without type-II diabetes (T2D). The supplemental new drug application was based on positive results from the DAPA-HF phase III study on Farxiga/Forxiga. Forxiga was approved in EU fora similar label expansion last month and in the United States in May 2020.
AstraZeneca announced an agreement to divest European rights (except the UK and Spain) to its lipid-lowering medicine Crestor to Grünenthal. Earlier, AstraZeneca divested rights to its acid reflux medicine, Nexium as well as several other established AstraZeneca medicines to Grünenthal. Upon closing of the deal, Grünenthal will make an upfront payment of $320 million to AstraZeneca.
The NYSE ARCA Pharmaceutical Index rose 1.9% in the last five trading sessions.
Watch out for pipeline and regulatory updates next week.
5 Stocks Set to Double
Each was hand-picked by a Zacks expert as the #1 favorite stock to gain +100% or more in 2020. Each comes from a different sector and has unique qualities and catalysts that could fuel exceptional growth.
Most of the stocks in this report are flying under Wall Street radar, which provides a great opportunity to get in on the ground floor.
Image: Bigstock
Pharma Stock Roundup: Approval of PFE/BNTX Coronavirus Vaccine in UK, Other Updates
This week, Pfizer (PFE - Free Report) and BioNTech’s (BNTX - Free Report) COVID-19 vaccine won approval in the United Kingdom. The companies also filed a formal marketing application with the European Medicines Agency (EMA) for their COVID-19 vaccine. Meanwhile, FDA approved Roche (RHHBY - Free Report) injectable biologic medicine, Xolair for its third indication.
Recap of the Week’s Most Important Stories
Pfizer/BioNTech’s BNT162b2 Gets Approved in United Kingdom: Pfizer/BioNTech’s mRNA-based coronavirus vaccine, BNT162b2 got its first approval in the world. The U.K. regulatory agency, Medicines & Healthcare Products Regulatory Agency (MHRA) granted it a temporary authorization for emergency use. The companies are ready to distribute the first doses in the U.K. immediately. Earlier, the companies had signed an agreement to supply a total of 40 million doses to the U.K. in 2020/2021.
The companies also applied for conditional marketing authorization (CMA) to the European Medicines Agency (EMA) for BNT162b2. In response to the CMA filing, the EMA said that its Committee for Human Medicines (CHMP) will review the quality, safety and effectiveness of the vaccine and will conclude its assessment by a meeting scheduled for Dec 29. The European Commission, the EU executive body, will give its final decision days after a recommendation by the EMA.
FDA Approves Roche’s Xolair for Third Indication: The FDA granted approval to Roche’s Xolair for the treatment of nasal polyps (in adult patients) that targets and blocks immunoglobulin E (IgE), a key driver of inflammation. Xolair is already approved for moderate-to-severe persistent allergic asthma for patients 6 years of age or older and chronic idiopathic urticaria (CIU) in people 12 years of age and older
Lilly to Supply More Bamlanivimab Doses to U.S. Government: Lilly (LLY - Free Report) signed a deal with the U.S. government to supply 6,50,000 doses of its antibody drug bamlanivimab (LY-CoV555), which was granted Emergency Use Authorization (EUA) by the FDA last month to treat recently diagnosed mild-to-moderate COVID-19 illness at high risk of progressing to severe COVID-19 or hospitalization. The doses will be delivered through Jan 31, 2021. However, Lilly will deliver at least 3,50,000 doses this month. The purchase deal is worth $812.5 million. With the latest purchase, the U.S. government has now purchased a total of 9,50,000 doses of bamlanivimab from Lilly.
AbbVie’s New R&D Partnership Deal: AbbVie (ABBV - Free Report) signed a multi-year collaboration deal with precision medicines company, Frontier Medicines, Corp. to discover and develop innovative small molecule programs directed against E3 ligase, immunology and oncology targets, which can be developed into highly differentiated and efficacious therapeutics. For the deal, AbbVie will make an upfront payment of $55 million to Frontier while the latter will be entitled to receive additional milestone payments.
J&J Files BLA for Lung Cancer Candidate: J&J (JNJ - Free Report) filed a biologics license application (BLA) seeking approval for amivantamab for treating patients with EGFR-mutated non-small cell lung cancer (NSCLC). The BLA submission for amivantamab is based on data from the monotherapy arm of the phase I CHRYSALIS study, which evaluated amivantamab as a monotherapy as well as in combination with third-generation tyrosine-kinase inhibitor (TKI) lazertinib in advanced NSCLC.
J&J acquired rights to an investigational gene therapy candidate, HMR59 from private biotech, Hemera Biosciences, being developed for late-stage age-related macular degeneration. The acquisition expands J&J’s eye disease portfolio and strengthens its gene therapy capabilities. Financial terms of the deal have not been disclosed.
Japan Approval for AstraZeneca’s Forxiga for Heart Failure: AstraZeneca’s (AZN - Free Report) Forxiga was approved in Japan for the treatment of chronic heart failure with reduced ejection fraction (HFrEF) in adults with and without type-II diabetes (T2D). The supplemental new drug application was based on positive results from the DAPA-HF phase III study on Farxiga/Forxiga. Forxiga was approved in EU fora similar label expansion last month and in the United States in May 2020.
AstraZeneca announced an agreement to divest European rights (except the UK and Spain) to its lipid-lowering medicine Crestor to Grünenthal. Earlier, AstraZeneca divested rights to its acid reflux medicine, Nexium as well as several other established AstraZeneca medicines to Grünenthal. Upon closing of the deal, Grünenthal will make an upfront payment of $320 million to AstraZeneca.
The NYSE ARCA Pharmaceutical Index rose 1.9% in the last five trading sessions.
Large Cap Pharmaceuticals Industry 5YR % Return
Large Cap Pharmaceuticals Industry 5YR % Return
Here’s how the eight major stocks performed in the last five trading sessions.
All the stocks were in the green last week except Lilly, which declined 0.5%. Pfizer recorded the maximum increase of 9.7%.
In the past six months, while AbbVie recorded the maximum increase (11.6%), Lilly declined the most (3.4%).
(See the last pharma stock roundup here: AZN COVID-19 Vaccine Interim Data, PFE Emergency Use Appeal)
What's Next in the Pharma World?
Watch out for pipeline and regulatory updates next week.
5 Stocks Set to Double
Each was hand-picked by a Zacks expert as the #1 favorite stock to gain +100% or more in 2020. Each comes from a different sector and has unique qualities and catalysts that could fuel exceptional growth.
Most of the stocks in this report are flying under Wall Street radar, which provides a great opportunity to get in on the ground floor.
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