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Pharma Stock Roundup: J&J, AZN COVID-19 Update, FDA Delays Decision on ABBV's sNDA
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This week J&J’s (JNJ - Free Report) single dose COVID-19 vaccine was granted Emergency Use Listing (EUL) by the World Health Organization (“WHO”). AstraZeneca (AZN - Free Report) announced a deal to supply additional doses of its potential COVID-19 antibody treatment to the United States. The FDA extended review period for expanded use of AbbVie’s (ABBV - Free Report) arthritis drug, Rinvoq.
Recap of the Week’s Most Important Stories
WHO Grants EUL to J&J’s COVID-19 Vaccine: WHO issued EUL for J&J’s single-shot COVID-19 vaccine candidate for individuals of 18 years of age and older. The EUL listing is an important prerequisite for supplying its vaccine through the COVAX Facility, which is co-led by Gavi. J&J already has an advance purchase agreement in place with Gavi to supply up to 500 million doses of its vaccine to the COVAX Facility through 2022.
Last week, the European Commission had granted Conditional Marketing Authorization (CMA) to the vaccine. The vaccine was granted Emergency Use Authorization (EUA) in the United States by the FDA late last month. The approval of J&J’s vaccine was based on interim efficacy and safety data from the ENSEMBLE phase III study on the vaccine candidate. The company has also begun rolling filings in other countries.
AstraZeneca to Supply More AZD7442 Doses to U.S. Government: AstraZeneca announced a deal to supply the U.S. government with up to 500,000 additional doses of AZD7442, its investigational cocktail antibody therapy, in late-stage development for the prevention and treatment of COVID-19. AZD7442 is a combo of two monoclonal antibodies, AZD8895 and AZD1061.
In October, AstraZeneca got a funding support of almost $486 million from the U.S. government for the development of AZD7442 and signed a deal to supply up to 100,000 doses to the government. Meanwhile, AstraZeneca has a separate agreement to supply the Department of Defense with 100,000 doses, bringing potential U.S. supplies of AZD7442 to 700,000 in 2021.
FDA Delays Decision of AbbVie’s Rinvoq sNDA: The FDA extended the review period for the supplemental new drug application (sNDA) seeking approval of AbbVie’s Rinvoq for a second indication — active psoriatic arthritis. The FDA’s action date has been delayed by three months to late second-quarter 2021. AbbVie recently submitted some information to the FDA relating to an updated assessment of the benefit-risk profile for upadacitinib for the psoriatic arthritis indication. The FDA needs additional time to review the data, which led to the extension. Rinvoq is approved for treating moderate-to-severe rheumatoid arthritis in the United States. Regulatory applications seeking approval of Rinvoq for ankylosing spondylitis as well as atopic dermatitis are under review in the United States.
Lilly’s Mirikizumab Meets Endpoints in Ulcerative Colitis Study: Lilly’s (LLY - Free Report) mirikizumab met primary endpoint and key secondary endpoints in phase III ulcerative colitis study. In the study, mirikizumab met the primary endpoint of clinical remission, by controlling/resolving the inflammation of the colon, at Week 12 versus placebo. Mirikizumab also achieved all key secondary endpoints compared to placebo at Week 12 by reducing bowel urgency, clinical response, endoscopic remission, symptomatic remission by high statistical significance.
Meanwhile, Lilly announced additional data on secondary endpoints of its phase II study on its antibody candidate, donanemab, in patients with early symptomatic Alzheimer's disease. The study had earlier met its primary endpoint in January with donanemab slowing disease progression significantly by 32% compared to placebo, as measured on the integrated Alzheimer's Disease Rating Scale (iADRS), over a treatment period of 76 weeks. The latest detailed data from the secondary analyses showed that donanemab consistently slowed cognitive and functional decline, with ranges between 20% and 40% in all secondary endpoints like Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) and Alzheimer's Disease Assessment Scale-Cognitive (ADAS-Cog13) with nominal statistical significance at multiple times compared to placebo. CDR-SB and ADAS-Cog13 are two more widely used scales than iADRS to measure the severity of Alzheimer’s disease. However, the data was weaker than investor expectations.
Sanofi’s Libtayo Improves Survival in Cervical Cancer Study: Sanofi (SNY - Free Report) announced positive results from a phase III study evaluating its cancer drug, Libtayo (cemiplimab) monotherapy in patients with advanced cervical cancer regardless of PD-L1 status. The Independent Data Monitoring Committee (IDMC) recommended the study be stopped early as the study data demonstrated an overall survival (OS) benefit in these patients. Patients receiving Libtayo experienced a 31% reduced risk of death (in total patient population) compared to chemotherapy. The company plans to file regulatory applications for the indication in 2021. Libtayo is approved for certain patients with advanced non-small cell lung cancer, basal cell carcinoma and advanced cutaneous squamous cell carcinoma.
FDA’s Priority Review Tag to Merck’s Belzutifan NDA: The FDA granted priority review to Merck’s (MRK - Free Report) NDA for novel HIF-2α inhibitor Belzutifan (MK-6482) for the treatment of patients with von Hippel-Lindau (VHL) disease-associated renal cell carcinoma (RCC). The designation was based on data from a phase II study on the candidate in patients with VHL-associated clear cell RCC. The FDA is expected to give its decision on Sep 15, 2021.
Meanwhile, the European Commission approved Merck’s Keytruda for expanded use in refractory classical Hodgkin lymphoma (cHL). The approval is for adult and pediatric patients with relapsed or refractory cHL who have disease progression after earlier lines of therapy or relapse after transplantation. The approval was based on data from the pivotal phase III KEYNOTE-204 study.
Glaxo/Medicago’s COVID-19 Vaccine Enters Phase III: Glaxo (GSK - Free Report) and partner Medicago announced the start of the phase III portion of the ongoing phase II/III study of their adjuvanted COVID-19 vaccine candidate. The study will enrol up to 30,000 volunteers worldwide. Medicago’s plant-derived vaccine candidate against COVID-19 is being developed in combination with Glaxo’s pandemic adjuvant. Results from the phase II portion of the study are expected in April.
The NYSE ARCA Pharmaceutical Index rose 0.7% in the last five trading sessions.
Watch out for regular pipeline and regulatory updates next week.
Zacks Top 10 Stocks for 2021
In addition to the stocks discussed above, would you like to know about our 10 best buy-and-hold tickers for the entirety of 2021?
Last year's 2020 Zacks Top 10 Stocks portfolio returned gains as high as +386.8%. Now a brand-new portfolio has been handpicked from over 4,000 companies covered by the Zacks Rank. Don’t miss your chance to get in on these long-term buys.
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Pharma Stock Roundup: J&J, AZN COVID-19 Update, FDA Delays Decision on ABBV's sNDA
This week J&J’s (JNJ - Free Report) single dose COVID-19 vaccine was granted Emergency Use Listing (EUL) by the World Health Organization (“WHO”). AstraZeneca (AZN - Free Report) announced a deal to supply additional doses of its potential COVID-19 antibody treatment to the United States. The FDA extended review period for expanded use of AbbVie’s (ABBV - Free Report) arthritis drug, Rinvoq.
Recap of the Week’s Most Important Stories
WHO Grants EUL to J&J’s COVID-19 Vaccine: WHO issued EUL for J&J’s single-shot COVID-19 vaccine candidate for individuals of 18 years of age and older. The EUL listing is an important prerequisite for supplying its vaccine through the COVAX Facility, which is co-led by Gavi. J&J already has an advance purchase agreement in place with Gavi to supply up to 500 million doses of its vaccine to the COVAX Facility through 2022.
Last week, the European Commission had granted Conditional Marketing Authorization (CMA) to the vaccine. The vaccine was granted Emergency Use Authorization (EUA) in the United States by the FDA late last month. The approval of J&J’s vaccine was based on interim efficacy and safety data from the ENSEMBLE phase III study on the vaccine candidate. The company has also begun rolling filings in other countries.
AstraZeneca to Supply More AZD7442 Doses to U.S. Government: AstraZeneca announced a deal to supply the U.S. government with up to 500,000 additional doses of AZD7442, its investigational cocktail antibody therapy, in late-stage development for the prevention and treatment of COVID-19. AZD7442 is a combo of two monoclonal antibodies, AZD8895 and AZD1061.
In October, AstraZeneca got a funding support of almost $486 million from the U.S. government for the development of AZD7442 and signed a deal to supply up to 100,000 doses to the government. Meanwhile, AstraZeneca has a separate agreement to supply the Department of Defense with 100,000 doses, bringing potential U.S. supplies of AZD7442 to 700,000 in 2021.
FDA Delays Decision of AbbVie’s Rinvoq sNDA: The FDA extended the review period for the supplemental new drug application (sNDA) seeking approval of AbbVie’s Rinvoq for a second indication — active psoriatic arthritis. The FDA’s action date has been delayed by three months to late second-quarter 2021. AbbVie recently submitted some information to the FDA relating to an updated assessment of the benefit-risk profile for upadacitinib for the psoriatic arthritis indication. The FDA needs additional time to review the data, which led to the extension. Rinvoq is approved for treating moderate-to-severe rheumatoid arthritis in the United States. Regulatory applications seeking approval of Rinvoq for ankylosing spondylitis as well as atopic dermatitis are under review in the United States.
Lilly’s Mirikizumab Meets Endpoints in Ulcerative Colitis Study: Lilly’s (LLY - Free Report) mirikizumab met primary endpoint and key secondary endpoints in phase III ulcerative colitis study. In the study, mirikizumab met the primary endpoint of clinical remission, by controlling/resolving the inflammation of the colon, at Week 12 versus placebo. Mirikizumab also achieved all key secondary endpoints compared to placebo at Week 12 by reducing bowel urgency, clinical response, endoscopic remission, symptomatic remission by high statistical significance.
Meanwhile, Lilly announced additional data on secondary endpoints of its phase II study on its antibody candidate, donanemab, in patients with early symptomatic Alzheimer's disease. The study had earlier met its primary endpoint in January with donanemab slowing disease progression significantly by 32% compared to placebo, as measured on the integrated Alzheimer's Disease Rating Scale (iADRS), over a treatment period of 76 weeks. The latest detailed data from the secondary analyses showed that donanemab consistently slowed cognitive and functional decline, with ranges between 20% and 40% in all secondary endpoints like Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) and Alzheimer's Disease Assessment Scale-Cognitive (ADAS-Cog13) with nominal statistical significance at multiple times compared to placebo. CDR-SB and ADAS-Cog13 are two more widely used scales than iADRS to measure the severity of Alzheimer’s disease. However, the data was weaker than investor expectations.
Sanofi’s Libtayo Improves Survival in Cervical Cancer Study: Sanofi (SNY - Free Report) announced positive results from a phase III study evaluating its cancer drug, Libtayo (cemiplimab) monotherapy in patients with advanced cervical cancer regardless of PD-L1 status. The Independent Data Monitoring Committee (IDMC) recommended the study be stopped early as the study data demonstrated an overall survival (OS) benefit in these patients. Patients receiving Libtayo experienced a 31% reduced risk of death (in total patient population) compared to chemotherapy. The company plans to file regulatory applications for the indication in 2021. Libtayo is approved for certain patients with advanced non-small cell lung cancer, basal cell carcinoma and advanced cutaneous squamous cell carcinoma.
FDA’s Priority Review Tag to Merck’s Belzutifan NDA: The FDA granted priority review to Merck’s (MRK - Free Report) NDA for novel HIF-2α inhibitor Belzutifan (MK-6482) for the treatment of patients with von Hippel-Lindau (VHL) disease-associated renal cell carcinoma (RCC). The designation was based on data from a phase II study on the candidate in patients with VHL-associated clear cell RCC. The FDA is expected to give its decision on Sep 15, 2021.
Meanwhile, the European Commission approved Merck’s Keytruda for expanded use in refractory classical Hodgkin lymphoma (cHL). The approval is for adult and pediatric patients with relapsed or refractory cHL who have disease progression after earlier lines of therapy or relapse after transplantation. The approval was based on data from the pivotal phase III KEYNOTE-204 study.
Glaxo/Medicago’s COVID-19 Vaccine Enters Phase III: Glaxo (GSK - Free Report) and partner Medicago announced the start of the phase III portion of the ongoing phase II/III study of their adjuvanted COVID-19 vaccine candidate. The study will enrol up to 30,000 volunteers worldwide. Medicago’s plant-derived vaccine candidate against COVID-19 is being developed in combination with Glaxo’s pandemic adjuvant. Results from the phase II portion of the study are expected in April.
The NYSE ARCA Pharmaceutical Index rose 0.7% 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.
Last week, Merck recorded the maximum gain (3.4%) while Lilly declined the most (9.1%).
In the past six months, Lilly recorded the maximum gain (23.5%) while AstraZeneca declined the most (10.5%).
(See the last pharma stock roundup here: EU Nod for J&J COVID-19 Vaccine, Updates From LLY, GSK, MRK)
What's Next in the Pharma World?
Watch out for regular pipeline and regulatory updates next week.
Zacks Top 10 Stocks for 2021
In addition to the stocks discussed above, would you like to know about our 10 best buy-and-hold tickers for the entirety of 2021?
Last year's 2020 Zacks Top 10 Stocks portfolio returned gains as high as +386.8%. Now a brand-new portfolio has been handpicked from over 4,000 companies covered by the Zacks Rank. Don’t miss your chance to get in on these long-term buys.
Access Zacks Top 10 Stocks for 2021 today >>