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Large Cap Pharma, Biotech Stocks Down on Regulatory Updates
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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 (PFE - Free Report) 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 (MRK - Free Report) 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.
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Meanwhile, in a major setback, the FDA revised the authorizations for two monoclonal antibody treatments – Eli Lilly’s (LLY - Free Report) bamlanivimab and etesevimab (administered together) and Regeneron’s (REGN - Free Report) 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 (GILD - Free Report) 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.
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Large Cap Pharma, Biotech Stocks 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 (PFE - Free Report) 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 (MRK - Free Report) 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 (LLY - Free Report) bamlanivimab and etesevimab (administered together) and Regeneron’s (REGN - Free Report) 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 (GILD - Free Report) 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.