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Pharma Stock Roundup: EU Approval to PFE, AZN Products, FDA Nod to LLY New COVID Drug
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This week, AstraZeneca's (AZN - Free Report) lupus drug Saphnelo and Pfizer’s (PFE - Free Report) pediatric growth hormone deficiency injection, Ngenla (somatrogon) and 20-valent pneumococcal conjugate vaccine, Apexxnar, were approved in Europe. The European regulatory submission of AstraZeneca and Sanofi’s (SNY - Free Report) nirsevimab vaccine was accepted under accelerated assessment for RSV protection in all infants. The FDA granted emergency approval to Eli Lilly’s (LLY - Free Report) new antibody-drug, bebtelovimab, to treat mild-to-moderate COVID-19.
Recap of the Week’s Most Important Stories
FDA Grants EUA to Lilly’s New COVID Antibody Drug: The FDA granted Emergency Use Authorization (EUA) to Lilly’s new antibody-drug bebtelovimab to treat certain non-hospitalized adults and pediatric patients with mild-to-moderate COVID-19 who are at high risk of progressing to severe disease. The EUA is based on data from the phase II BLAZE-4 study. Pseudovirus and authentic virus testing of bebtelovimab showed that the antibody retains full neutralizing activity against Omicron. Also, an authentic virus analysis of bebtelovimab demonstrated that bebtelovimab neutralizes all known variants of concern, including Omicron.
Pfizer’s Ngenla & Apexxnar Get Approved in Europe: Pfizer gained approval for its pediatric growth hormone deficiency once-weekly injection, Ngenla (somatrogon) and its 20-valent pneumococcal conjugate vaccine, Apexxnar, in Europe. Ngenla is already approved in Japan, Australia and Canada. However, it is not approved in the United States. The 20-valent pneumococcal conjugate vaccine was approved in the United States in June 2021 where it is marketed by the trade name of Prevnar 20.
Pfizer and BioNTech are delaying their rolling submission seeking approval to expand their COVID-19 vaccine’s EUA to allow their use in children 6 months through 4 years of age at the request of the FDA.
The companies initiated a rolling submission for the EUA of their COVID-19 vaccine in children 6 months through 4 years of age in early January. The companies submitted available data on the safety and efficacy of two 3 µg doses as part of a three-dose primary series for this age group while the study is ongoing. However, the companies will wait for data for the third 3 µg dose from the ongoing study, which is expected to be available in early April. This pushes the timeline for potential emergency approval of the vaccine for this age group.
European Approval for AstraZeneca's Lupus Drug Saphnelo: The European Commission approved AstraZeneca’s biologic drug, Saphnelo (anifrolumab), to treat moderate-to-severe active autoantibody-positive systemic lupus erythematosus (SLE), the most common form of lupus. Saphnelo’s approval was based on data from two TULIP phase III studies and the MUSE phase II study. Saphnelo is the first biologic to be approved to treat SLE in Europe with the label not restricted for use in patients with a high degree of disease activity.
The European Medicines Agency (EMA) accepted AstraZeneca and Sanofi’s marketing authorization application (MAA) for the nirsevimab vaccine under an accelerated assessment procedure to help prevent medically attended lower respiratory tract infections (LRTI) in all infants entering their first RSV season.
The MAA for the AstraZeneca/Sanofi vaccine is based on data from the from the MELODY phase III, MEDLEY phase II/III, and phase IIb study.
The NYSE ARCA Pharmaceutical Index declined 0.9% in the last five trading sessions.
Image: Bigstock
Pharma Stock Roundup: EU Approval to PFE, AZN Products, FDA Nod to LLY New COVID Drug
This week, AstraZeneca's (AZN - Free Report) lupus drug Saphnelo and Pfizer’s (PFE - Free Report) pediatric growth hormone deficiency injection, Ngenla (somatrogon) and 20-valent pneumococcal conjugate vaccine, Apexxnar, were approved in Europe. The European regulatory submission of AstraZeneca and Sanofi’s (SNY - Free Report) nirsevimab vaccine was accepted under accelerated assessment for RSV protection in all infants. The FDA granted emergency approval to Eli Lilly’s (LLY - Free Report) new antibody-drug, bebtelovimab, to treat mild-to-moderate COVID-19.
Recap of the Week’s Most Important Stories
FDA Grants EUA to Lilly’s New COVID Antibody Drug: The FDA granted Emergency Use Authorization (EUA) to Lilly’s new antibody-drug bebtelovimab to treat certain non-hospitalized adults and pediatric patients with mild-to-moderate COVID-19 who are at high risk of progressing to severe disease. The EUA is based on data from the phase II BLAZE-4 study. Pseudovirus and authentic virus testing of bebtelovimab showed that the antibody retains full neutralizing activity against Omicron. Also, an authentic virus analysis of bebtelovimab demonstrated that bebtelovimab neutralizes all known variants of concern, including Omicron.
Pfizer’s Ngenla & Apexxnar Get Approved in Europe: Pfizer gained approval for its pediatric growth hormone deficiency once-weekly injection, Ngenla (somatrogon) and its 20-valent pneumococcal conjugate vaccine, Apexxnar, in Europe. Ngenla is already approved in Japan, Australia and Canada. However, it is not approved in the United States. The 20-valent pneumococcal conjugate vaccine was approved in the United States in June 2021 where it is marketed by the trade name of Prevnar 20.
Pfizer and BioNTech are delaying their rolling submission seeking approval to expand their COVID-19 vaccine’s EUA to allow their use in children 6 months through 4 years of age at the request of the FDA.
The companies initiated a rolling submission for the EUA of their COVID-19 vaccine in children 6 months through 4 years of age in early January. The companies submitted available data on the safety and efficacy of two 3 µg doses as part of a three-dose primary series for this age group while the study is ongoing. However, the companies will wait for data for the third 3 µg dose from the ongoing study, which is expected to be available in early April. This pushes the timeline for potential emergency approval of the vaccine for this age group.
European Approval for AstraZeneca's Lupus Drug Saphnelo: The European Commission approved AstraZeneca’s biologic drug, Saphnelo (anifrolumab), to treat moderate-to-severe active autoantibody-positive systemic lupus erythematosus (SLE), the most common form of lupus. Saphnelo’s approval was based on data from two TULIP phase III studies and the MUSE phase II study. Saphnelo is the first biologic to be approved to treat SLE in Europe with the label not restricted for use in patients with a high degree of disease activity.
The European Medicines Agency (EMA) accepted AstraZeneca and Sanofi’s marketing authorization application (MAA) for the nirsevimab vaccine under an accelerated assessment procedure to help prevent medically attended lower respiratory tract infections (LRTI) in all infants entering their first RSV season.
The MAA for the AstraZeneca/Sanofi vaccine is based on data from the from the MELODY phase III, MEDLEY phase II/III, and phase IIb study.
The NYSE ARCA Pharmaceutical Index declined 0.9% 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.
Image Source: Zacks Investment Research
In the last five trading sessions, AstraZeneca rose the most (4%), while Pfizer declined the most (3.4%).
In the past six months, AbbVie has recorded the maximum gain (25.8%) while Lilly declined the most (10.2%)
(See the last pharma stock roundup here: PFE, AZN, GSK’s Q4 Earnings, FDA Updates for SNY, LLY)
What's Next in the Pharma World?
Watch out for regular pipeline and regulatory updates next week.