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The Zacks Analyst Blog Highlights: Pfizer, Merck, Eli Lilly, Regeneron and Gilead
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For Immediate Release
Chicago, IL – January 26, 2022 – 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: Pfizer (PFE - Free Report) , Merck (MRK - Free Report) , Eli Lilly (LLY - Free Report) , Regeneron (REGN - Free Report) and Gilead (GILD - Free Report) .
Here are highlights from Tuesday’s Analyst Blog:
Large-Cap Pharma, Biotech Down on Regulatory Updates
It was a rough day for investors in the stock market as most indices were in red as news of the Federal Reserve raising interest rates continues to loom large.
While the markets, in general, were trading down, pharma and biotech stocks took a beating on negative regulatory updates as well.
Pharma giant Pfizer and partner Opko Health received a setback as the FDA issued a Complete Response Letter (CRL) for the biologics license application (BLA) for somatrogon. The candidate is an investigational once-weekly long-acting recombinant human growth hormone for the treatment of growth hormone deficiency (GHD) in pediatric patients. Pfizer will work with the agency to determine the road ahead.
The FDA issued a CRL for Merck’s new drug application (NDA) for gefapixant. The NDA was seeking approval of this investigational, non-narcotic, orally administered selective P2X3 receptor antagonist for the treatment of refractory chronic cough (RCC) or unexplained chronic cough (UCC) in adults.
In the CRL, the regulatory body requested additional information related to the measurement of efficacy. Merck is reviewing the letter and will meet with the agency to discuss the next steps. The safety of the candidate is not being questioned.
Shares of Pfizer and Merck were down 2.37% and 1.44%, respectively, on the news.
Meanwhile, in a major setback, the FDA revised the authorizations for two monoclonal antibody treatments – Eli Lilly’s bamlanivimab and etesevimab (administered together) and Regeneron’s REGEN-COV (casirivimab and imdevimab).
Data showed that these treatments are highly unlikely to be active against the Omicron variant, which is spreading rapidly throughout the United States. Hence, the regulatory body has stated these treatments are no longer authorized for use in any U.S. states, territories and jurisdictions at this time.
The agency also added that if patients in certain regions are likely to be infected or exposed to a variant susceptible to these treatments, then the use of these treatments may be authorized in these regions.
Consequently, both Regeneron and Eli Lilly are down in after-market trading.
Earlier, the NIH COVID-19 Treatment Guidelines Panel, an independent panel of national experts, recommended against the use of bamlanivimab and etesevimab and REGEN-COV due to their markedly reduced activity against the Omicron variant.
Per FDA, Pfizer’s Paxlovid, sotrovimab, Gilead’s Veklury (remdesivir) and Merck’s molnupiravir are expected to work against the Omicron variant.
In fact, the regulatory body has granted expedited approval to a supplemental new drug application (sNDA) for Gilead’s Veklury for the treatment of non-hospitalized adult and adolescent patients who are at high risk of progression to severe COVID-19, including hospitalization or death.
It was earlier indicated for adults and pediatric patients (12 years of age and older and weighing at least 40 kg) for the treatment of COVID-19 requiring hospitalization.
The FDA has also expanded the pediatric Emergency Use Authorization (EUA) of Veklury to include non-hospitalized pediatric patients younger than 12 years of age who are at high risk of disease progression.
While Pfizer currently sports a Zacks Rank #1 (Strong Buy), Regeneron carries a Zacks Rank #2 (Buy). Both Merck and Gilead carry a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank stocks here.
Infrastructure Stock Boom to Sweep America
A massive push to rebuild the crumbling U.S. infrastructure will soon be underway. It’s bipartisan, urgent, and inevitable. Trillions will be spent. Fortunes will be made.
The only question is “Will you get into the right stocks early when their growth potential is greatest?”
Zacks has released a Special Report to help you do just that, and today it’s free. Discover 5 special companies that look to gain the most from construction and repair to roads, bridges, and buildings, plus cargo hauling and energy transformation on an almost unimaginable scale.
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: Pfizer, Merck, Eli Lilly, Regeneron and Gilead
For Immediate Release
Chicago, IL – January 26, 2022 – 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: Pfizer (PFE - Free Report) , Merck (MRK - Free Report) , Eli Lilly (LLY - Free Report) , Regeneron (REGN - Free Report) and Gilead (GILD - Free Report) .
Here are highlights from Tuesday’s Analyst Blog:
Large-Cap Pharma, Biotech Down on Regulatory Updates
It was a rough day for investors in the stock market as most indices were in red as news of the Federal Reserve raising interest rates continues to loom large.
While the markets, in general, were trading down, pharma and biotech stocks took a beating on negative regulatory updates as well.
Pharma giant Pfizer and partner Opko Health received a setback as the FDA issued a Complete Response Letter (CRL) for the biologics license application (BLA) for somatrogon. The candidate is an investigational once-weekly long-acting recombinant human growth hormone for the treatment of growth hormone deficiency (GHD) in pediatric patients. Pfizer will work with the agency to determine the road ahead.
The FDA issued a CRL for Merck’s new drug application (NDA) for gefapixant. The NDA was seeking approval of this investigational, non-narcotic, orally administered selective P2X3 receptor antagonist for the treatment of refractory chronic cough (RCC) or unexplained chronic cough (UCC) in adults.
In the CRL, the regulatory body requested additional information related to the measurement of efficacy. Merck is reviewing the letter and will meet with the agency to discuss the next steps. The safety of the candidate is not being questioned.
Shares of Pfizer and Merck were down 2.37% and 1.44%, respectively, on the news.
Meanwhile, in a major setback, the FDA revised the authorizations for two monoclonal antibody treatments – Eli Lilly’s bamlanivimab and etesevimab (administered together) and Regeneron’s REGEN-COV (casirivimab and imdevimab).
Data showed that these treatments are highly unlikely to be active against the Omicron variant, which is spreading rapidly throughout the United States. Hence, the regulatory body has stated these treatments are no longer authorized for use in any U.S. states, territories and jurisdictions at this time.
The agency also added that if patients in certain regions are likely to be infected or exposed to a variant susceptible to these treatments, then the use of these treatments may be authorized in these regions.
Consequently, both Regeneron and Eli Lilly are down in after-market trading.
Earlier, the NIH COVID-19 Treatment Guidelines Panel, an independent panel of national experts, recommended against the use of bamlanivimab and etesevimab and REGEN-COV due to their markedly reduced activity against the Omicron variant.
Per FDA, Pfizer’s Paxlovid, sotrovimab, Gilead’s Veklury (remdesivir) and Merck’s molnupiravir are expected to work against the Omicron variant.
In fact, the regulatory body has granted expedited approval to a supplemental new drug application (sNDA) for Gilead’s Veklury for the treatment of non-hospitalized adult and adolescent patients who are at high risk of progression to severe COVID-19, including hospitalization or death.
It was earlier indicated for adults and pediatric patients (12 years of age and older and weighing at least 40 kg) for the treatment of COVID-19 requiring hospitalization.
The FDA has also expanded the pediatric Emergency Use Authorization (EUA) of Veklury to include non-hospitalized pediatric patients younger than 12 years of age who are at high risk of disease progression.
While Pfizer currently sports a Zacks Rank #1 (Strong Buy), Regeneron carries a Zacks Rank #2 (Buy). Both Merck and Gilead carry a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank stocks here.
Infrastructure Stock Boom to Sweep America
A massive push to rebuild the crumbling U.S. infrastructure will soon be underway. It’s bipartisan, urgent, and inevitable. Trillions will be spent. Fortunes will be made.
The only question is “Will you get into the right stocks early when their growth potential is greatest?”
Zacks has released a Special Report to help you do just that, and today it’s free. Discover 5 special companies that look to gain the most from construction and repair to roads, bridges, and buildings, plus cargo hauling and energy transformation on an almost unimaginable scale.
Download FREE: How to Profit from Trillions on Spending for Infrastructure >>
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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.