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Pharma Stock Roundup: PFE Booster Works on Omicron, AZN COVID Cocktail Gets FDA Nod
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This week, Pfizer (PFE - Free Report) and BioNTech said that a booster shot of their COVID-19 vaccine neutralized the Omicron variant while the two-dose regimen was less effective. The FDA granted emergency approval to AstraZeneca’s (AZN - Free Report) cocktail antibody drug, Evusheld to prevent COVID-19 symptoms before virus exposure and to Eli Lilly’s (LLY - Free Report) COVID-19 antibody cocktail, bamlanivimab plus etesevimab for use in children and infants. Merck (MRK - Free Report) paused enrollment in two HIV studies while AbbVie’s (ABBV - Free Report) phase III Crohn’s disease study on upadacitinib met its goal.
Recap of the Week’s Most Important Stories
Pfizer Booster Dose Effective Against Omicron: Pfizer and BioNTech announced data from preliminary laboratory studies, which showed that three doses of their COVID vaccine, neutralized against infection with the Omicron variant, while two doses showed significantly reduced neutralization titers. The data showed that the third dose increased the antibodies against the Omicron variant by 25-fold compared to the two doses. The data indicated that though two shots of the vaccine may still be effective at preventing severe infection caused by the Omicron variant, the protection gets better with a third shot. The companies also said that they are developing an Omicron-specific COVID-19 vaccine, which they can bring to the market by March 2022, if the need arises.
The FDA expanded Pfizer and BioNTech’s Emergency Use Authorization (EUA) for the booster dose to allow its use in individuals 16 and 17 years of age at least six months following completion of primary vaccination with Pfizer/BioNTech’s COVID-19 vaccine, Comirnaty. Pfizer/BioNTech’s booster dose was granted emergency approval by the FDA last month for all adults 18 years of age and older.
FDA Approves AstraZeneca’s Evusheld for COVID Prevention in Some Individuals: The FDA granted EUA to AstraZeneca’s Evusheld (formerly AZD7442) for pre-exposure prophylaxis (prevention) of COVID-19 in some immunocompromised individuals and those who cannot get vaccinated. With emergency approval from the FDA, AstraZeneca’s Evusheld is the first cocktail antibody drug approved in the United States to prevent COVID-19 symptoms before virus exposure.
Merck Pauses Enrollment in HIV Study: Merck paused enrolment in two phase III studies evaluating its once-monthly investigational nucleoside reverse transcriptase translocation inhibitor, oral islatravir, for the treatment of pre-exposure prophylaxis (PrEP) of HIV-1 infection. Enrolment in the IMPOWER 22 and IMPOWER 24 studies was stopped at the recommendation of the ISL PrEP external data monitoring committee (eDMC). Merck is conducting further analyses of these studies while implementing additional monitoring measures for study participants at the recommendations of the committee.
The FDA approved Merck’s blockbuster PD-L1 inhibitor, Keytruda for adjuvant treatment of adult and pediatric patients (aged 12 years and above) with stage IIB or IIC melanoma following complete resection. The FDA also granted approval to Keytruda as an adjuvant treatment for pediatric patients (aged 12 years and above) with stage III melanoma following complete resection. Please note that Keytruda is already approved as an adjuvant treatment for adult patients with stage III melanoma following complete resection.
FDA Authorizes Lilly’s Cocktail COVID Antibody for Kids: The FDA expanded the EUA granted to Lilly’s COVID-19 antibody cocktail, bamlanivimab plus etesevimab to allow its use in high-risk COVID-19 pediatric and infant patients both for treatment as well as for post-exposure prophylaxis. Bamlanivimab plus etesevimab was granted EUA by the FDA in February 2021 to treat mild-to-moderate COVID-19 in high-risk patients. In September, the FDA expanded the EUA for the cocktail antibody medicine to include the post-exposure prevention (prophylaxis) for the COVID-19 indication. With the approval in children and infants, Lilly’s bamlanivimab with etesevimab can now be given as treatment and prevention options to high-risk individuals of any age.
AbbVie’s Rinvoq Meets Goal in Crohn’s Disease Study: AbbVie announced that a phase III induction study evaluating upadacitinib in patients with moderate-to-severe Crohn's disease achieved its co-primary as well as key secondary endpoints. In the U-EXCEED study, a significantly higher proportion of Crohn’s disease patients treated with upadacitinib (45 mg once daily for induction) achieved the primary endpoints of clinical remission and endoscopic response compared to placebo at week 12. Upadacitinib is marketed as Rinvoq for moderately to severely active rheumatoid arthritis in the United States and Europe. In Europe, it is approved for three other indications, moderate-to-severe atopic dermatitis, active psoriatic arthritis and active ankylosing spondylitis.
AbbVie also updated the label of JAK inhibitor, Rinvoq to include new warnings about an increased risk of serious heart-related events, cancer, blood clots, and even death. The update follows a Drug Safety Communication (“DSC”) issued by the FDA in September. Per the new label update for Rinvoq, the FDA is also limiting approved use of the drug to certain RA patients who have not responded or cannot tolerate one or more tumor necrosis factor (TNF) blockers.
The NYSE ARCA Pharmaceutical Index rose 2.02% in the last five trading sessions.
Image: Shutterstock
Pharma Stock Roundup: PFE Booster Works on Omicron, AZN COVID Cocktail Gets FDA Nod
This week, Pfizer (PFE - Free Report) and BioNTech said that a booster shot of their COVID-19 vaccine neutralized the Omicron variant while the two-dose regimen was less effective. The FDA granted emergency approval to AstraZeneca’s (AZN - Free Report) cocktail antibody drug, Evusheld to prevent COVID-19 symptoms before virus exposure and to Eli Lilly’s (LLY - Free Report) COVID-19 antibody cocktail, bamlanivimab plus etesevimab for use in children and infants. Merck (MRK - Free Report) paused enrollment in two HIV studies while AbbVie’s (ABBV - Free Report) phase III Crohn’s disease study on upadacitinib met its goal.
Recap of the Week’s Most Important Stories
Pfizer Booster Dose Effective Against Omicron: Pfizer and BioNTech announced data from preliminary laboratory studies, which showed that three doses of their COVID vaccine, neutralized against infection with the Omicron variant, while two doses showed significantly reduced neutralization titers. The data showed that the third dose increased the antibodies against the Omicron variant by 25-fold compared to the two doses. The data indicated that though two shots of the vaccine may still be effective at preventing severe infection caused by the Omicron variant, the protection gets better with a third shot. The companies also said that they are developing an Omicron-specific COVID-19 vaccine, which they can bring to the market by March 2022, if the need arises.
The FDA expanded Pfizer and BioNTech’s Emergency Use Authorization (EUA) for the booster dose to allow its use in individuals 16 and 17 years of age at least six months following completion of primary vaccination with Pfizer/BioNTech’s COVID-19 vaccine, Comirnaty. Pfizer/BioNTech’s booster dose was granted emergency approval by the FDA last month for all adults 18 years of age and older.
FDA Approves AstraZeneca’s Evusheld for COVID Prevention in Some Individuals: The FDA granted EUA to AstraZeneca’s Evusheld (formerly AZD7442) for pre-exposure prophylaxis (prevention) of COVID-19 in some immunocompromised individuals and those who cannot get vaccinated. With emergency approval from the FDA, AstraZeneca’s Evusheld is the first cocktail antibody drug approved in the United States to prevent COVID-19 symptoms before virus exposure.
Merck Pauses Enrollment in HIV Study: Merck paused enrolment in two phase III studies evaluating its once-monthly investigational nucleoside reverse transcriptase translocation inhibitor, oral islatravir, for the treatment of pre-exposure prophylaxis (PrEP) of HIV-1 infection. Enrolment in the IMPOWER 22 and IMPOWER 24 studies was stopped at the recommendation of the ISL PrEP external data monitoring committee (eDMC). Merck is conducting further analyses of these studies while implementing additional monitoring measures for study participants at the recommendations of the committee.
The FDA approved Merck’s blockbuster PD-L1 inhibitor, Keytruda for adjuvant treatment of adult and pediatric patients (aged 12 years and above) with stage IIB or IIC melanoma following complete resection. The FDA also granted approval to Keytruda as an adjuvant treatment for pediatric patients (aged 12 years and above) with stage III melanoma following complete resection. Please note that Keytruda is already approved as an adjuvant treatment for adult patients with stage III melanoma following complete resection.
FDA Authorizes Lilly’s Cocktail COVID Antibody for Kids: The FDA expanded the EUA granted to Lilly’s COVID-19 antibody cocktail, bamlanivimab plus etesevimab to allow its use in high-risk COVID-19 pediatric and infant patients both for treatment as well as for post-exposure prophylaxis. Bamlanivimab plus etesevimab was granted EUA by the FDA in February 2021 to treat mild-to-moderate COVID-19 in high-risk patients. In September, the FDA expanded the EUA for the cocktail antibody medicine to include the post-exposure prevention (prophylaxis) for the COVID-19 indication. With the approval in children and infants, Lilly’s bamlanivimab with etesevimab can now be given as treatment and prevention options to high-risk individuals of any age.
AbbVie’s Rinvoq Meets Goal in Crohn’s Disease Study: AbbVie announced that a phase III induction study evaluating upadacitinib in patients with moderate-to-severe Crohn's disease achieved its co-primary as well as key secondary endpoints. In the U-EXCEED study, a significantly higher proportion of Crohn’s disease patients treated with upadacitinib (45 mg once daily for induction) achieved the primary endpoints of clinical remission and endoscopic response compared to placebo at week 12. Upadacitinib is marketed as Rinvoq for moderately to severely active rheumatoid arthritis in the United States and Europe. In Europe, it is approved for three other indications, moderate-to-severe atopic dermatitis, active psoriatic arthritis and active ankylosing spondylitis.
AbbVie also updated the label of JAK inhibitor, Rinvoq to include new warnings about an increased risk of serious heart-related events, cancer, blood clots, and even death. The update follows a Drug Safety Communication (“DSC”) issued by the FDA in September. Per the new label update for Rinvoq, the FDA is also limiting approved use of the drug to certain RA patients who have not responded or cannot tolerate one or more tumor necrosis factor (TNF) blockers.
The NYSE ARCA Pharmaceutical Index rose 2.02% 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.
In the last five trading sessions, AbbVie rose the most (6.2%) while Lilly declined the most (2.0%)
In the past six months, Pfizer has recorded the maximum gain (32.1%) while Novartis has declined the most (13.2%)
(See the last pharma stock roundup here: FDA Panel Vote for MRK COVID Pill, JNJ Omicron Jab Plan)
What's Next in the Pharma World?
Watch out for regular pipeline and regulatory updates next week.