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Pharma Stock Roundup: FDA Panel's Nod to PFE/BNTX Coronavirus Vaccine, Other Updates
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This week, an FDA advisory committee recommended granting emergency use authorization (EUA) to Pfizer (PFE - Free Report) and BioNTech’s COVID-19 vaccine. Glaxo (GSK - Free Report) /Sanofi (SNY - Free Report) announced a delay in their coronavirus vaccine development program. Lilly (LLY - Free Report) and AbbVie (ABBV - Free Report) announced successful late-stage study results.
Recap of the Week’s Most Important Stories
FDA Panel Recommends Emergency Use of Pfizer’s COVID-19 Vaccine: The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted 17-4 recommending FDA grant EUA to Pfizer/BioNTech’s mRNA-based coronavirus vaccine candidate, BNT162b2.The recommendation was based on data from a phase III study, announced last month, which showed that BNT162b2 was 95% effective in preventing COVID-19 after two doses were given three weeks apart.
BNT162b2 is already approved for emergency use in United Kingdom, Bahrain and Canada. Pfizer/BioNTech had filed the EUA to the FDA on Nov 20. The FDA should give its decision in a few days’ time. Vaccinations are expected to begin almost immediately after the FDA gives the green signal.
The FDA accepted and granted priority review to Pfizer’s biologics license application (BLA) seeking approval for its 20-valent pneumococcal conjugate vaccine candidate, 20vPnC, for adults. The FDA’s decision is expected in June 2021. The candidate helps protect against 20 serotypes responsible for the majority of invasive pneumococcal disease and pneumonia.
Glaxo/Sanofi’s COVID-19 Vaccine Development Plan Delayed: Glaxo and Sanofi announced a delay in the development plans of their adjuvanted recombinant protein-based COVID-19 vaccine candidate due to insufficient immune response in older adults in early-stage studies. The vaccine is being developed by combining Sanofi’s recombinant protein-based technology with Glaxo’s pandemic adjuvant technology. Data from a phase I/II study showed that in adults aged 18 to 49 years, the candidate showed an immune response comparable to patients who recovered from COVID-19. However, in older adults, the candidate demonstrated a low immune response, which the companies believe may be due to an insufficient concentration of the antigen.
Accordingly, the companies now plan to start a phase IIb study with an improved antigen formulation in February, which will include a proposed comparison with an authorized COVID-19 vaccine. If the data are positive, the companies plan to start a phase III study in the second quarter of 2021.
The companies plan to file for regulatory approval in the second half of 2021, delayed from the earlier expectation of regulatory filings in the first half. The vaccine is now expected to be available in the fourth quarter of next year, if successfully developed, delayed from mid-2021 expected previously.
Lilly’s Diabetes Candidate, Tirzepatide Succeeds in Phase III: Top-line data from a phase III study (SURPASS-1) on Lilly’s tirzepatide, a dual GIP and GLP-1 receptor agonist (GIP/GLP-1 RA), showed that the candidate led to superior blood sugar reductions (A1C reduction) and weight loss in type II diabetes patients. After 40 weeks of treatment, the highest dose of tirzepatide led to a 2.07% reduction in A1C levels and weight loss of 9.5 kgs. Meanwhile, more than half of participants taking the highest dose (15 mg) achieved normal A1C levels (A1C less than 5.7 percent), a key secondary endpoint of the study. Tirzepatide is also in phase III studies for obesity and phase II study in NASH.
Lilly and UnitedHealth Group launched a pragmatic study to evaluate Lilly’s COVID-19 antibody drug, bamlanivimab (LY-CoV555) in high-risk, COVID-19 infected individuals. Bamlanivimab recently received emergency-use authorization (EUA) from the FDA for the treatment of recently diagnosed mild-to-moderate COVID-19 illness at high risk of progressing to severe COVID-19 or hospitalization. The study will detect and treat high-risk symptomatic patients who test positive for COVID-19 and includes in-home testing and in-home infusions.
AbbVie’s Rinvoq Meets Goals in Ulcerative Colitis Study: AbbVie’s phase III induction study (U-ACHIEVE) evaluating its JAK1 inhibitor, Rinvoq/upadacitinib for moderately-to-severely active ulcerative colitis (UC) met the primary endpoint of clinical remission and all ranked secondary endpoints including clinical, endoscopic and histologic outcomes. In the study, 26% of patients given Rinvoq/upadacitinib achieved clinical remission at week 8 compared to 5% in the placebo group. Rinvoq is presently approved to treat moderate-to-severe rheumatoid arthritis (RA) and is under review in the United States and EU for ankylosing spondylitis, psoriatic arthritis & atopic dermatitis indications.
Novartis’ Leqvio Gets Approval in EU: The European Commission approved Novartis’ (NVS - Free Report) Leqvio (inclisiran), a first-in-class treatment for hyperlipidemia or mixed dyslipidemia. in adults. The approval of this potentially transformative cholesterol-lowering therapy is based on data from the ORION phase III LDL-C-lowering studies. Inclisiran was added to Novartis’ portfolio with the acquisition of The Medicines Company, which closed in January this year. Leqvio is currently under review in the United States
FDA Accepts Glaxo’s Filings for Nucala in 4th Indication: The FDA accepted Glaxo’s regulatory filing seeking approval of Nucala for a new indication, chronic rhinosinusitis with nasal polyps (CRSwNP). Nucala, an anti-IL5 biologic, is presently marketed for eosinophil-driven diseases like severe eosinophilic asthma, eosinophilic granulomatosis with polyangiitis and hypereosinophilic syndrome (HES) in the United States.
Roche Partners Moderna for COVID-19 Antibody Test: Roche (RHHBY - Free Report) signed a deal with Moderna to use its Elecsys SARS-CoV-2 antibody test, which targets the spike protein, in ongoing studies on the latter’s coronavirus vaccine candidate, mRNA-1273. The test was grated EUA by the FDA last month. Moderna had used Roche’s Elecsys Anti-SARS-CoV-2 test targeting the nucleocapsid protein in early clinical studies.
The NYSE ARCA Pharmaceutical Index rose 2.2% in the last five trading sessions.
Zacks has just released a Special Report on the booming investment opportunities of legal marijuana.
Ignited by referendums and legislation, this industry is expected to blast from an already robust $17.7 billion in 2019 to a staggering $73.6 billion by 2027. Early investors stand to make a killing, but you have to be ready to act and know just where to look.
Image: Bigstock
Pharma Stock Roundup: FDA Panel's Nod to PFE/BNTX Coronavirus Vaccine, Other Updates
This week, an FDA advisory committee recommended granting emergency use authorization (EUA) to Pfizer (PFE - Free Report) and BioNTech’s COVID-19 vaccine. Glaxo (GSK - Free Report) /Sanofi (SNY - Free Report) announced a delay in their coronavirus vaccine development program. Lilly (LLY - Free Report) and AbbVie (ABBV - Free Report) announced successful late-stage study results.
Recap of the Week’s Most Important Stories
FDA Panel Recommends Emergency Use of Pfizer’s COVID-19 Vaccine: The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted 17-4 recommending FDA grant EUA to Pfizer/BioNTech’s mRNA-based coronavirus vaccine candidate, BNT162b2.The recommendation was based on data from a phase III study, announced last month, which showed that BNT162b2 was 95% effective in preventing COVID-19 after two doses were given three weeks apart.
BNT162b2 is already approved for emergency use in United Kingdom, Bahrain and Canada. Pfizer/BioNTech had filed the EUA to the FDA on Nov 20. The FDA should give its decision in a few days’ time. Vaccinations are expected to begin almost immediately after the FDA gives the green signal.
The FDA accepted and granted priority review to Pfizer’s biologics license application (BLA) seeking approval for its 20-valent pneumococcal conjugate vaccine candidate, 20vPnC, for adults. The FDA’s decision is expected in June 2021. The candidate helps protect against 20 serotypes responsible for the majority of invasive pneumococcal disease and pneumonia.
Glaxo/Sanofi’s COVID-19 Vaccine Development Plan Delayed: Glaxo and Sanofi announced a delay in the development plans of their adjuvanted recombinant protein-based COVID-19 vaccine candidate due to insufficient immune response in older adults in early-stage studies. The vaccine is being developed by combining Sanofi’s recombinant protein-based technology with Glaxo’s pandemic adjuvant technology. Data from a phase I/II study showed that in adults aged 18 to 49 years, the candidate showed an immune response comparable to patients who recovered from COVID-19. However, in older adults, the candidate demonstrated a low immune response, which the companies believe may be due to an insufficient concentration of the antigen.
Accordingly, the companies now plan to start a phase IIb study with an improved antigen formulation in February, which will include a proposed comparison with an authorized COVID-19 vaccine. If the data are positive, the companies plan to start a phase III study in the second quarter of 2021.
The companies plan to file for regulatory approval in the second half of 2021, delayed from the earlier expectation of regulatory filings in the first half. The vaccine is now expected to be available in the fourth quarter of next year, if successfully developed, delayed from mid-2021 expected previously.
Lilly’s Diabetes Candidate, Tirzepatide Succeeds in Phase III: Top-line data from a phase III study (SURPASS-1) on Lilly’s tirzepatide, a dual GIP and GLP-1 receptor agonist (GIP/GLP-1 RA), showed that the candidate led to superior blood sugar reductions (A1C reduction) and weight loss in type II diabetes patients. After 40 weeks of treatment, the highest dose of tirzepatide led to a 2.07% reduction in A1C levels and weight loss of 9.5 kgs. Meanwhile, more than half of participants taking the highest dose (15 mg) achieved normal A1C levels (A1C less than 5.7 percent), a key secondary endpoint of the study. Tirzepatide is also in phase III studies for obesity and phase II study in NASH.
Lilly and UnitedHealth Group launched a pragmatic study to evaluate Lilly’s COVID-19 antibody drug, bamlanivimab (LY-CoV555) in high-risk, COVID-19 infected individuals. Bamlanivimab recently received emergency-use authorization (EUA) from the FDA for the treatment of recently diagnosed mild-to-moderate COVID-19 illness at high risk of progressing to severe COVID-19 or hospitalization. The study will detect and treat high-risk symptomatic patients who test positive for COVID-19 and includes in-home testing and in-home infusions.
AbbVie’s Rinvoq Meets Goals in Ulcerative Colitis Study: AbbVie’s phase III induction study (U-ACHIEVE) evaluating its JAK1 inhibitor, Rinvoq/upadacitinib for moderately-to-severely active ulcerative colitis (UC) met the primary endpoint of clinical remission and all ranked secondary endpoints including clinical, endoscopic and histologic outcomes. In the study, 26% of patients given Rinvoq/upadacitinib achieved clinical remission at week 8 compared to 5% in the placebo group. Rinvoq is presently approved to treat moderate-to-severe rheumatoid arthritis (RA) and is under review in the United States and EU for ankylosing spondylitis, psoriatic arthritis & atopic dermatitis indications.
Novartis’ Leqvio Gets Approval in EU: The European Commission approved Novartis’ (NVS - Free Report) Leqvio (inclisiran), a first-in-class treatment for hyperlipidemia or mixed dyslipidemia. in adults. The approval of this potentially transformative cholesterol-lowering therapy is based on data from the ORION phase III LDL-C-lowering studies. Inclisiran was added to Novartis’ portfolio with the acquisition of The Medicines Company, which closed in January this year. Leqvio is currently under review in the United States
FDA Accepts Glaxo’s Filings for Nucala in 4th Indication: The FDA accepted Glaxo’s regulatory filing seeking approval of Nucala for a new indication, chronic rhinosinusitis with nasal polyps (CRSwNP). Nucala, an anti-IL5 biologic, is presently marketed for eosinophil-driven diseases like severe eosinophilic asthma, eosinophilic granulomatosis with polyangiitis and hypereosinophilic syndrome (HES) in the United States.
Roche Partners Moderna for COVID-19 Antibody Test: Roche (RHHBY - Free Report) signed a deal with Moderna to use its Elecsys SARS-CoV-2 antibody test, which targets the spike protein, in ongoing studies on the latter’s coronavirus vaccine candidate, mRNA-1273. The test was grated EUA by the FDA last month. Moderna had used Roche’s Elecsys Anti-SARS-CoV-2 test targeting the nucleocapsid protein in early clinical studies.
The NYSE ARCA Pharmaceutical Index rose 2.2% 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.
All the stocks were in the green last week with Lilly recording the maximum increase of 11.7%.
In the past six months, while Pfizer recorded the maximum increase (23.7%), Roche rose the minimum (1%).
(See the last pharma stock roundup here: Approval of PFE/BNTX Coronavirus Vaccine in UK, Other Updates)
Looking for Stocks with Skyrocketing Upside?
Zacks has just released a Special Report on the booming investment opportunities of legal marijuana.
Ignited by referendums and legislation, this industry is expected to blast from an already robust $17.7 billion in 2019 to a staggering $73.6 billion by 2027. Early investors stand to make a killing, but you have to be ready to act and know just where to look.
See the pot stocks we're targeting >>