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The Zacks Analyst Blog Highlights: AstraZeneca, Eli Lilly, Sanofi, GlaxoSmithKline and Novartis
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For Immediate Release
Chicago, IL – February 16, 2021 – Zacks.com announces the list of stocks featured in the Analyst Blog. Every day the Zacks Equity Research analysts discuss the latest news and events impacting stocks and the financial markets. Stocks recently featured in the blog include: AstraZeneca PLC (AZN - Free Report) , Eli Lilly and Company (LLY - Free Report) , Sanofi (SNY - Free Report) , GlaxoSmithKline plc (GSK - Free Report) and Novartis AG (NVS - Free Report) .
Here are highlights from Friday’s Analyst Blog:
Pharma Stock Roundup: Earnings & FDA Approvals
This week, AstraZeneca announced better-than-expected fourth-quarter earnings. The FDA granted emergency approval to a combination of Eli Lilly’s antibody drugs for COVID-19 and regular approval to Sanofi’s Libtayo for its second skin cancer indication.
Recap of the Week’s Most Important Stories
AstraZeneca Beats on Q4 Earnings: AstraZeneca’s fourth-quarter earnings and sales beat estimates. While core earnings per share rose 24% year over year at constant exchange rates (“CER”), total revenues were up 10% a CER. Product sales rose 11% at CER.
In 2021, the company expects total revenues to increase in low-teens percentage. Core earnings are expected to remain between $4.75 and $5.00 per share.
Separately, AstraZeneca’s phase III study evaluating Imfinzi for the first-line treatment of recurrent or metastatic head and neck cancer did not meet the primary endpoint of improving overall survival (OS) compared to standard-of-care medicines,
FDA Grants EUA to Lilly’s COVID-19 Antibody Combo: The FDA granted Emergency Use Authorization (EUA) to a combination of Lilly’s antibody drugs, bamlanivimab (700 mg) and etesevimab (1400 mg) for the treatment of recently diagnosed mild-to-moderate COVID-19 illness at high risk of progressing to severe COVID-19. The EUA was based on data from the phase III BLAZE-1 study, which was released last month.
Bamlanivimab already has an EUA from the FDA as a monotherapy for the treatment of high-risk patients recently diagnosed with mild-to-moderate COVID-19. The FDA also authorized a shortened infusion time for bamlanivimab alone as well as bamlanivimab/etesevimab cocktail.
FDA Approves Sanofi’s Libtayo for 2nd Skin Cancer Indication: The FDA also approved Sanofi/Regeneron’s skin cancer drug, Libtayo for treating advanced basal cell carcinoma (BCC), a non-melanoma skin cancer. The FDA also granted accelerated approval for patients with metastatic BCC.
Libtayo is presently approved to treat metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC. With the approval for BCC, the drug is now approved for advanced stages of the two most common skin cancers in the United States.
Meanwhile, the European Commission approved a new indication for Sanofi’s blood thinner drug, Plavix. It can now be prescribed in combination with aspirin to treat adult patients with moderate to high-risk Transient Ischemic Attack (TIA) or minor Ischemic Stroke (IS) within 24 hours of either the TIA or IS event.
EU Approves Glaxo’s Rukobia: The European Commission granted approval to Glaxo’s Rukobia (fostemsavir) in combination with other antiretroviral (ARV) therapies to treat heavily treatment-experienced adult patients with multidrug-resistant HIV. The approval of Rukobia 600mg extended-release tablets was based on data from the pivotal phase III BRIGHTE study. Rukobia was approved by the FDA in July last year.
Separately, Glaxo announced an agreement to divest its Cephalosporin antibiotics business to Novartis’ generics unit, Sandoz. For the sale, Sandoz will pay Glaxo $350 million at closing and the latter will also be entitled to milestone payments of up to $150 million. The transaction is expected to close in the second half of 2021.
FDA’s Breakthrough Tag for Novartis’ Leukemia Candidate: The FDA granted Breakthrough Therapy designation to Novartis’ investigational STAMP inhibitor, asciminib (ABL001) for the treatment of Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase previously treated with two or more tyrosine kinase inhibitors The tag was granted based on data from the pivotal phase III ASCEMBL study, where asciminib was compared to Bosulif in the above patient population. An application seeking approval for asciminib is expected to be filed in the first half of 2021.
The NYSE ARCA Pharmaceutical Index rose 1% in the last five trading sessions.
Past performance is no guarantee of future results. Inherent in any investment is the potential for loss. This material is being provided for informational purposes only and nothing herein constitutes investment, legal, accounting or tax advice, or a recommendation to buy, sell or hold a security. No recommendation or advice is being given as to whether any investment is suitable for a particular investor. It should not be assumed that any investments in securities, companies, sectors or markets identified and described were or will be profitable. All information is current as of the date of herein and is subject to change without notice. Any views or opinions expressed may not reflect those of the firm as a whole. Zacks Investment Research does not engage in investment banking, market making or asset management activities of any securities. These returns are from hypothetical portfolios consisting of stocks with Zacks Rank = 1 that were rebalanced monthly with zero transaction costs. These are not the returns of actual portfolios of stocks. The S&P 500 is an unmanaged index. Visit https://www.zacks.com/performance for information about the performance numbers displayed in this press release.
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The Zacks Analyst Blog Highlights: AstraZeneca, Eli Lilly, Sanofi, GlaxoSmithKline and Novartis
For Immediate Release
Chicago, IL – February 16, 2021 – Zacks.com announces the list of stocks featured in the Analyst Blog. Every day the Zacks Equity Research analysts discuss the latest news and events impacting stocks and the financial markets. Stocks recently featured in the blog include: AstraZeneca PLC (AZN - Free Report) , Eli Lilly and Company (LLY - Free Report) , Sanofi (SNY - Free Report) , GlaxoSmithKline plc (GSK - Free Report) and Novartis AG (NVS - Free Report) .
Here are highlights from Friday’s Analyst Blog:
Pharma Stock Ro undup: Earnings & FDA Approvals
This week, AstraZeneca announced better-than-expected fourth-quarter earnings. The FDA granted emergency approval to a combination of Eli Lilly’s antibody drugs for COVID-19 and regular approval to Sanofi’s Libtayo for its second skin cancer indication.
Recap of the Week’s Most Important Stories
AstraZeneca Beats on Q4 Earnings: AstraZeneca’s fourth-quarter earnings and sales beat estimates. While core earnings per share rose 24% year over year at constant exchange rates (“CER”), total revenues were up 10% a CER. Product sales rose 11% at CER.
In 2021, the company expects total revenues to increase in low-teens percentage. Core earnings are expected to remain between $4.75 and $5.00 per share.
Separately, AstraZeneca’s phase III study evaluating Imfinzi for the first-line treatment of recurrent or metastatic head and neck cancer did not meet the primary endpoint of improving overall survival (OS) compared to standard-of-care medicines,
FDA Grants EUA to Lilly’s COVID-19 Antibody Combo: The FDA granted Emergency Use Authorization (EUA) to a combination of Lilly’s antibody drugs, bamlanivimab (700 mg) and etesevimab (1400 mg) for the treatment of recently diagnosed mild-to-moderate COVID-19 illness at high risk of progressing to severe COVID-19. The EUA was based on data from the phase III BLAZE-1 study, which was released last month.
Bamlanivimab already has an EUA from the FDA as a monotherapy for the treatment of high-risk patients recently diagnosed with mild-to-moderate COVID-19. The FDA also authorized a shortened infusion time for bamlanivimab alone as well as bamlanivimab/etesevimab cocktail.
FDA Approves Sanofi’s Libtayo for 2nd Skin Cancer Indication: The FDA also approved Sanofi/Regeneron’s skin cancer drug, Libtayo for treating advanced basal cell carcinoma (BCC), a non-melanoma skin cancer. The FDA also granted accelerated approval for patients with metastatic BCC.
Libtayo is presently approved to treat metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC. With the approval for BCC, the drug is now approved for advanced stages of the two most common skin cancers in the United States.
Meanwhile, the European Commission approved a new indication for Sanofi’s blood thinner drug, Plavix. It can now be prescribed in combination with aspirin to treat adult patients with moderate to high-risk Transient Ischemic Attack (TIA) or minor Ischemic Stroke (IS) within 24 hours of either the TIA or IS event.
EU Approves Glaxo’s Rukobia: The European Commission granted approval to Glaxo’s Rukobia (fostemsavir) in combination with other antiretroviral (ARV) therapies to treat heavily treatment-experienced adult patients with multidrug-resistant HIV. The approval of Rukobia 600mg extended-release tablets was based on data from the pivotal phase III BRIGHTE study. Rukobia was approved by the FDA in July last year.
Separately, Glaxo announced an agreement to divest its Cephalosporin antibiotics business to Novartis’ generics unit, Sandoz. For the sale, Sandoz will pay Glaxo $350 million at closing and the latter will also be entitled to milestone payments of up to $150 million. The transaction is expected to close in the second half of 2021.
FDA’s Breakthrough Tag for Novartis’ Leukemia Candidate: The FDA granted Breakthrough Therapy designation to Novartis’ investigational STAMP inhibitor, asciminib (ABL001) for the treatment of Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase previously treated with two or more tyrosine kinase inhibitors The tag was granted based on data from the pivotal phase III ASCEMBL study, where asciminib was compared to Bosulif in the above patient population. An application seeking approval for asciminib is expected to be filed in the first half of 2021.
The NYSE ARCA Pharmaceutical Index rose 1% in the last five trading sessions.
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Past performance is no guarantee of future results. Inherent in any investment is the potential for loss. This material is being provided for informational purposes only and nothing herein constitutes investment, legal, accounting or tax advice, or a recommendation to buy, sell or hold a security. No recommendation or advice is being given as to whether any investment is suitable for a particular investor. It should not be assumed that any investments in securities, companies, sectors or markets identified and described were or will be profitable. All information is current as of the date of herein and is subject to change without notice. Any views or opinions expressed may not reflect those of the firm as a whole. Zacks Investment Research does not engage in investment banking, market making or asset management activities of any securities. These returns are from hypothetical portfolios consisting of stocks with Zacks Rank = 1 that were rebalanced monthly with zero transaction costs. These are not the returns of actual portfolios of stocks. The S&P 500 is an unmanaged index. Visit https://www.zacks.com/performance for information about the performance numbers displayed in this press release.