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Pharma Stock Roundup: GSK, SNY Face Pipeline Setbacks, AZN Cancer Study Meets Goals
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This week, Glaxo (GSK - Free Report) paused enrollment in a late-stage RSV vaccine study while Sanofi (SNY - Free Report) stopped a chronic spontaneous urticaria (CSU) study on its blockbuster immunology medicine, Dupixent. AstraZeneca (AZN - Free Report) and partner Daiichi Sankyo’s cancer drug, Enhertu met the primary and key secondary endpoints in a phase III study in patients with HER2-low metastatic breast cancer. AbbVie (ABBV - Free Report) filed a regulatory application with the FDA seeking approval of its drug Vraylar (cariprazine) for a fourth indication. The FDA approved Eli Lilly’s (LLY - Free Report) Jardiance to treat adults with heart failure regardless of left ventricular ejection fraction.
Recap of the Week’s Most Important Stories
Sanofi’s Dupixent Urticaria Study to be Stopped: Sanofi’s phase III study evaluating Dupixent in patients with CSU, who were refractory to omalizumab, will be stopped due to futility. In the study, Dupixent failed to reach statistical significance in an interim analysis (conducted by an independent review committee) despite numeric improvements observed across key endpoints like reducing itch and hives. Sanofi remains committed to study Dupixent for patients with CSU uncontrolled on antihistamines and is evaluating the next steps.
Glaxo Pauses Enrollment in RSV Maternal Vaccine Studies: Glaxo has paused enrollment and vaccination in the phase III RSV maternal vaccine candidate study (GRACE) as well as two other studies evaluating the candidate in pregnant women following a recommendation from the Independent Data Monitoring Committee. The committee’s recommendation was based on observation from a routine safety assessment. However, the RSV vaccine study in older adults continues and is not affected by the decision. Data from this study is expected in the first half of 2022.
Glaxo announced that it is on track to demerge and list its Consumer Healthcare unit as a new company in mid-2022. The new independent Consumer Healthcare company has been named Haleon.
Glaxo and Sanofi plan to soon file regulatory applications in the United States and Europe seeking approval for their adjuvanted protein-based COVID-19 vaccine. The companies will submit data from both their booster and phase III efficacy studies as the basis of the filing.
In people who have already taken a two-dose primary vaccine of another company, their booster dose generated a significant increase in neutralizing antibodies of 18- to 30-fold across vaccine platforms and age groups. In people who had taken the Sanofi/Glaxo vaccine as a two-dose primary series followed by a booster dose, neutralizing antibodies increased 84-to 153-fold compared to the pre-boost levels. Meanwhile, a two-dose primary vaccination with their vaccine demonstrated 57.9% efficacy against symptomatic COVID-19.
Glaxo also announced that it and partner Medicago’s adjuvanted plant-based COVID-19 vaccine, Covifenz has been approved by Health Canada.
AstraZeneca’s Enhertu Succeeds in HER2-low Breast Cancer Study: AstraZeneca and Daiichi Sankyo announced data from the phase III DESTINY-Breast04 study on HER2-directed antibody-drug conjugate (ADC), Enhertu in HER2-low metastatic breast cancer. In the study, Enhertu demonstrated a statistically significant and clinically meaningful improvement in both progression-free survival (PFS) and overall survival (OS) in the patient population.
More than 50% of all primary breast cancers show a low-level expression of HER2, which is defined as HER2-low. This low HER2 expression level is not currently eligible for HER2-targeted therapy and is therefore a promising new target for HER2-directed ADC drugs like Enhertu. The positive data from the DESTINY-Breast04 study has the potential to redefine how breast cancer is treated because no HER2-directed therapy has ever before shown any benefit in patients with HER2-low metastatic breast cancer.
AbbVie Seeks Approval for Vraylar for MDD: AbbVie submitted a supplemental new drug application (sNDA) to the FDA seeking approval of its drug Vraylar (cariprazine) for the adjunctive treatment of patients with major depressive disorder (MDD). The sNDA was based on data from two phase III studies evaluating cariprazine (Vraylar) as an adjunctive treatment MDD. Vraylar is presently approved for treating schizophrenia, the acute treatment of manic or mixed episodes associated with bipolar I disorder and depressive episodes associated with bipolar I disorder.
AbbVie’s second phase III induction study evaluating upadacitinib in patients with moderate-to-severe Crohn's disease met its co-primary endpoints and well as most key secondary endpoints. In the U-EXCEL, study, a significantly higher proportion of Crohn’s disease patients treated with upadacitinib (45 mg once daily for induction) achieved both primary endpoints of clinical remission and endoscopic response compared to placebo at week 12. The first phase III induction study for Crohn's disease, U-EXCEED had also achieved similar results. Upadacitinib is marketed as Rinvoq for moderately to severely active rheumatoid arthritis, moderate-to-severe atopic dermatitis and active psoriatic arthritis.
FDA Approves Lilly’s Jardiance for All Types of Heart Failure: Lilly announced that the FDA has approved its diabetes drug, Jardiance to reduce the risk of cardiovascular death plus hospitalization for heart failure in adults with heart failure with preserved left ventricular ejection fraction (LVEF). This approval was based on results from the landmark EMPEROR-Preserved phase III study. Jardiance was approved for another type of heart failure, heart failure in people with reduced LVEF in United States and Europe in mid-2021
With the latest approval, Jardiance is now approved for reducing cardiovascular death and hospitalization for heart failure, regardless of ejection fraction
The NYSE ARCA Pharmaceutical Index declined 2.8% in the last five trading sessions.
Image: Bigstock
Pharma Stock Roundup: GSK, SNY Face Pipeline Setbacks, AZN Cancer Study Meets Goals
This week, Glaxo (GSK - Free Report) paused enrollment in a late-stage RSV vaccine study while Sanofi (SNY - Free Report) stopped a chronic spontaneous urticaria (CSU) study on its blockbuster immunology medicine, Dupixent. AstraZeneca (AZN - Free Report) and partner Daiichi Sankyo’s cancer drug, Enhertu met the primary and key secondary endpoints in a phase III study in patients with HER2-low metastatic breast cancer. AbbVie (ABBV - Free Report) filed a regulatory application with the FDA seeking approval of its drug Vraylar (cariprazine) for a fourth indication. The FDA approved Eli Lilly’s (LLY - Free Report) Jardiance to treat adults with heart failure regardless of left ventricular ejection fraction.
Recap of the Week’s Most Important Stories
Sanofi’s Dupixent Urticaria Study to be Stopped: Sanofi’s phase III study evaluating Dupixent in patients with CSU, who were refractory to omalizumab, will be stopped due to futility. In the study, Dupixent failed to reach statistical significance in an interim analysis (conducted by an independent review committee) despite numeric improvements observed across key endpoints like reducing itch and hives. Sanofi remains committed to study Dupixent for patients with CSU uncontrolled on antihistamines and is evaluating the next steps.
Glaxo Pauses Enrollment in RSV Maternal Vaccine Studies: Glaxo has paused enrollment and vaccination in the phase III RSV maternal vaccine candidate study (GRACE) as well as two other studies evaluating the candidate in pregnant women following a recommendation from the Independent Data Monitoring Committee. The committee’s recommendation was based on observation from a routine safety assessment. However, the RSV vaccine study in older adults continues and is not affected by the decision. Data from this study is expected in the first half of 2022.
Glaxo announced that it is on track to demerge and list its Consumer Healthcare unit as a new company in mid-2022. The new independent Consumer Healthcare company has been named Haleon.
Glaxo and Sanofi plan to soon file regulatory applications in the United States and Europe seeking approval for their adjuvanted protein-based COVID-19 vaccine. The companies will submit data from both their booster and phase III efficacy studies as the basis of the filing.
In people who have already taken a two-dose primary vaccine of another company, their booster dose generated a significant increase in neutralizing antibodies of 18- to 30-fold across vaccine platforms and age groups. In people who had taken the Sanofi/Glaxo vaccine as a two-dose primary series followed by a booster dose, neutralizing antibodies increased 84-to 153-fold compared to the pre-boost levels. Meanwhile, a two-dose primary vaccination with their vaccine demonstrated 57.9% efficacy against symptomatic COVID-19.
Glaxo also announced that it and partner Medicago’s adjuvanted plant-based COVID-19 vaccine, Covifenz has been approved by Health Canada.
AstraZeneca’s Enhertu Succeeds in HER2-low Breast Cancer Study: AstraZeneca and Daiichi Sankyo announced data from the phase III DESTINY-Breast04 study on HER2-directed antibody-drug conjugate (ADC), Enhertu in HER2-low metastatic breast cancer. In the study, Enhertu demonstrated a statistically significant and clinically meaningful improvement in both progression-free survival (PFS) and overall survival (OS) in the patient population.
More than 50% of all primary breast cancers show a low-level expression of HER2, which is defined as HER2-low. This low HER2 expression level is not currently eligible for HER2-targeted therapy and is therefore a promising new target for HER2-directed ADC drugs like Enhertu. The positive data from the DESTINY-Breast04 study has the potential to redefine how breast cancer is treated because no HER2-directed therapy has ever before shown any benefit in patients with HER2-low metastatic breast cancer.
AbbVie Seeks Approval for Vraylar for MDD: AbbVie submitted a supplemental new drug application (sNDA) to the FDA seeking approval of its drug Vraylar (cariprazine) for the adjunctive treatment of patients with major depressive disorder (MDD). The sNDA was based on data from two phase III studies evaluating cariprazine (Vraylar) as an adjunctive treatment MDD. Vraylar is presently approved for treating schizophrenia, the acute treatment of manic or mixed episodes associated with bipolar I disorder and depressive episodes associated with bipolar I disorder.
AbbVie’s second phase III induction study evaluating upadacitinib in patients with moderate-to-severe Crohn's disease met its co-primary endpoints and well as most key secondary endpoints. In the U-EXCEL, study, a significantly higher proportion of Crohn’s disease patients treated with upadacitinib (45 mg once daily for induction) achieved both primary endpoints of clinical remission and endoscopic response compared to placebo at week 12. The first phase III induction study for Crohn's disease, U-EXCEED had also achieved similar results. Upadacitinib is marketed as Rinvoq for moderately to severely active rheumatoid arthritis, moderate-to-severe atopic dermatitis and active psoriatic arthritis.
FDA Approves Lilly’s Jardiance for All Types of Heart Failure: Lilly announced that the FDA has approved its diabetes drug, Jardiance to reduce the risk of cardiovascular death plus hospitalization for heart failure in adults with heart failure with preserved left ventricular ejection fraction (LVEF). This approval was based on results from the landmark EMPEROR-Preserved phase III study. Jardiance was approved for another type of heart failure, heart failure in people with reduced LVEF in United States and Europe in mid-2021
With the latest approval, Jardiance is now approved for reducing cardiovascular death and hospitalization for heart failure, regardless of ejection fraction
The NYSE ARCA Pharmaceutical Index declined 2.8% 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, Lilly rose the most (0.9%) while Pfizer declined the most (6%).
In the past six months, AbbVie has recorded the maximum gain (23.4%) while J&J declined the most (7.5%)
(See the last pharma stock roundup here: EU Approval to PFE, AZN Products, FDA Nod to LLY New COVID Drug)
What's Next in the Pharma World?
Watch out for regular pipeline and regulatory updates next week.