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Pharma Stock Roundup: AZN's Q4 Earnings, FDA Approval for LLY & SNY's Drugs
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This week AstraZeneca (AZN - Free Report) announced better-than-expected fourth-quarter earnings. The FDA granted emergency approval to a combination of Eli Lilly’s (LLY - Free Report) antibody drugs for COVID-19 and regular approval to Sanofi’s (SNY - Free Report) 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 (GSK - Free Report) 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’ (NVS - Free Report) 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 Approves New Pediatric Indication for AbbVie’s Botox: The FDA granted approval to AbbVie’s (ABBV - Free Report) neurotoxin Botox for treating detrusor (bladder muscle) overactivity associated with a neurologic condition in pediatric patients who are not adequately managed with anticholinergic medication. Botox is the only drug approved to treat pediatric neurogenic detrusor overactivity. The approval marks the 12th approved therapeutic indication for Botox in the United States.
Meanwhile, AbbVie announced a multi-year collaboration deal with Caribou Biosciences for developing two CAR-T cell therapies for selected targets. The therapies will be developed by leveraging Caribou's next-generation CRISPR genome editing technology platform. While Caribou will take care of pre-clinical development, AbbVie will be responsible for clinical development.
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.
Watch out for regular pipeline and regulatory updates next week.
Zacks Top 10 Stocks for 2021
In addition to the stocks discussed above, would you like to know about our 10 best buy-and-hold tickers for the entirety of 2021?
Last year's 2020 Zacks Top 10 Stocks portfolio returned gains as high as +386.8%. Now a brand-new portfolio has been handpicked from over 4,000 companies covered by the Zacks Rank. Don’t miss your chance to get in on these long-term buys.
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Pharma Stock Roundup: AZN's Q4 Earnings, FDA Approval for LLY & SNY's Drugs
This week AstraZeneca (AZN - Free Report) announced better-than-expected fourth-quarter earnings. The FDA granted emergency approval to a combination of Eli Lilly’s (LLY - Free Report) antibody drugs for COVID-19 and regular approval to Sanofi’s (SNY - Free Report) 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 (GSK - Free Report) 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’ (NVS - Free Report) 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 Approves New Pediatric Indication for AbbVie’s Botox: The FDA granted approval to AbbVie’s (ABBV - Free Report) neurotoxin Botox for treating detrusor (bladder muscle) overactivity associated with a neurologic condition in pediatric patients who are not adequately managed with anticholinergic medication. Botox is the only drug approved to treat pediatric neurogenic detrusor overactivity. The approval marks the 12th approved therapeutic indication for Botox in the United States.
Meanwhile, AbbVie announced a multi-year collaboration deal with Caribou Biosciences for developing two CAR-T cell therapies for selected targets. The therapies will be developed by leveraging Caribou's next-generation CRISPR genome editing technology platform. While Caribou will take care of pre-clinical development, AbbVie will be responsible for clinical development.
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.
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.
Last week, J&J (JNJ - Free Report) recorded the maximum gain (2.5%) while AbbVie declined the most (4.4%).
In the past six months, Lilly recorded the maximum gain (35.4%) while AstraZeneca declined the most (10.2%).
(See the last pharma stock roundup here: PFE, MRK, ABBV’s Q4 Earnings, AZN & JNJ’s Coronavirus Vaccine Updates)
What's Next in the Pharma World?
Watch out for regular pipeline and regulatory updates next week.
Zacks Top 10 Stocks for 2021
In addition to the stocks discussed above, would you like to know about our 10 best buy-and-hold tickers for the entirety of 2021?
Last year's 2020 Zacks Top 10 Stocks portfolio returned gains as high as +386.8%. Now a brand-new portfolio has been handpicked from over 4,000 companies covered by the Zacks Rank. Don’t miss your chance to get in on these long-term buys.
Access Zacks Top 10 Stocks for 2021 today >>