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Pharma Stock Roundup: JNJ to Buy Shockwave Medical, Other Pipeline & Regulatory News
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This week, J&J (JNJ - Free Report) proposed to buy medical device company Shockwave Medical (SWAV - Free Report) for approximately $13.1 billion. The buyout will strengthen JNJ’s MedTech cardiovascular portfolio. The FDA approved AstraZeneca (AZN - Free Report) and partner Daiichi Sankyo’s Enhertu for the fifth indication, metastatic HER2-positive solid tumors. Pfizer (PFE - Free Report) released promising results from a phase III study evaluating its RSV vaccine, Abrysvo, in higher-risk adults aged 18 to 59.
Recap of the Week’s Most Important Stories
J&J to Buy Shockwave Medical: J&J offered to buy medical device company Shockwave Medical for approximately $13.1 billion. The acquisition will strengthen J&J’s MedTech cardiovascular portfolio by adding Shockwave’s leading IVL (intravascular lithotripsy) technology. The acquisition will strengthen MerdTech’s position in high-growth cardiovascular intervention segments — coronary artery disease (CAD) and peripheral artery disease (PAD). The IVL catheter-based product works through the local delivery of sonic pressure waves for the treatment of calcified plaque in arteries. These calcified plaques reduce blood flow and cause pain or heart attack. ShockWave Medical’s IVL catheters are used in both CAD and PAD. J&J will acquire all outstanding shares of Shockwave for $335.00 per share in cash.
FDA Approves AstraZeneca’s Enhertu for Solid Tumors: The FDA granted accelerated approval to AstraZeneca/Daiichi Sankyo’s Enhertu for treating unresectable or metastatic HER2-positive solid tumors in heavily pretreated patients. The approval was based on data from three phase II studies, which showed clinically meaningful responses across a broad range of tumors. With the approval, Enhertu has become the first HER2-directed medicine to receive a tumor-agnostic indication.
Enhertu is presently approved for advanced or metastatic HER2-positive gastric cancer, previously treated HER2-mutant metastatic non-small cell lung cancer and metastatic HER2-positive and HER2-low breast cancer. The metastatic HER2-positive solid tumor indication is the fifth indication for Enhertu.
The FDA also approved AstraZeneca’s blockbuster drug, Fasenra, as an add-on maintenance treatment for pediatric patients aged 6 to 11 with severe asthma. Fasenra was until now approved as an add-on maintenance treatment for patients aged 12 and above with severe asthma in the United States.
Pfizer’s Abrysvo Phase III Study in Adults 18-59 Meets Endpoint: Pfizer’s phase III study evaluating its new respiratory syncytial virus (RSV) Abrysvo in adults aged 18 to 59 met its primary endpoints.
Abrysvo has already been launched to help protect older adults, as well as infants, through maternal immunization in the United States as well as the EU. The study called MONeT evaluated the immunogenicity and safety of Abrysvo versus placebo in adults aged 18 to 59 with certain underlying chronic conditions such as asthma, diabetes and chronic obstructive pulmonary disease and are so are at an increased risk for RSV disease. The study met its co-primary immunogenicity endpoints and primary safety endpoint. In the study, the immune response generated by Abrysvo was non-inferior to the responses seen in the study conducted in adults aged 60 or older, where vaccine efficacy is already demonstrated.
Pfizer plans to seek approval from the FDA for the expanded use of Abrysvo for adults 18 years and older by submitting these data. However, the company did not provide any timeline for the filing.
The NYSE ARCA Pharmaceutical Index declined 0.84% in the last five trading sessions.
Image: Bigstock
Pharma Stock Roundup: JNJ to Buy Shockwave Medical, Other Pipeline & Regulatory News
This week, J&J (JNJ - Free Report) proposed to buy medical device company Shockwave Medical (SWAV - Free Report) for approximately $13.1 billion. The buyout will strengthen JNJ’s MedTech cardiovascular portfolio. The FDA approved AstraZeneca (AZN - Free Report) and partner Daiichi Sankyo’s Enhertu for the fifth indication, metastatic HER2-positive solid tumors. Pfizer (PFE - Free Report) released promising results from a phase III study evaluating its RSV vaccine, Abrysvo, in higher-risk adults aged 18 to 59.
Recap of the Week’s Most Important Stories
J&J to Buy Shockwave Medical: J&J offered to buy medical device company Shockwave Medical for approximately $13.1 billion. The acquisition will strengthen J&J’s MedTech cardiovascular portfolio by adding Shockwave’s leading IVL (intravascular lithotripsy) technology. The acquisition will strengthen MerdTech’s position in high-growth cardiovascular intervention segments — coronary artery disease (CAD) and peripheral artery disease (PAD). The IVL catheter-based product works through the local delivery of sonic pressure waves for the treatment of calcified plaque in arteries. These calcified plaques reduce blood flow and cause pain or heart attack. ShockWave Medical’s IVL catheters are used in both CAD and PAD. J&J will acquire all outstanding shares of Shockwave for $335.00 per share in cash.
FDA Approves AstraZeneca’s Enhertu for Solid Tumors: The FDA granted accelerated approval to AstraZeneca/Daiichi Sankyo’s Enhertu for treating unresectable or metastatic HER2-positive solid tumors in heavily pretreated patients. The approval was based on data from three phase II studies, which showed clinically meaningful responses across a broad range of tumors. With the approval, Enhertu has become the first HER2-directed medicine to receive a tumor-agnostic indication.
Enhertu is presently approved for advanced or metastatic HER2-positive gastric cancer, previously treated HER2-mutant metastatic non-small cell lung cancer and metastatic HER2-positive and HER2-low breast cancer. The metastatic HER2-positive solid tumor indication is the fifth indication for Enhertu.
The FDA also approved AstraZeneca’s blockbuster drug, Fasenra, as an add-on maintenance treatment for pediatric patients aged 6 to 11 with severe asthma. Fasenra was until now approved as an add-on maintenance treatment for patients aged 12 and above with severe asthma in the United States.
Pfizer’s Abrysvo Phase III Study in Adults 18-59 Meets Endpoint: Pfizer’s phase III study evaluating its new respiratory syncytial virus (RSV) Abrysvo in adults aged 18 to 59 met its primary endpoints.
Abrysvo has already been launched to help protect older adults, as well as infants, through maternal immunization in the United States as well as the EU. The study called MONeT evaluated the immunogenicity and safety of Abrysvo versus placebo in adults aged 18 to 59 with certain underlying chronic conditions such as asthma, diabetes and chronic obstructive pulmonary disease and are so are at an increased risk for RSV disease. The study met its co-primary immunogenicity endpoints and primary safety endpoint. In the study, the immune response generated by Abrysvo was non-inferior to the responses seen in the study conducted in adults aged 60 or older, where vaccine efficacy is already demonstrated.
Pfizer plans to seek approval from the FDA for the expanded use of Abrysvo for adults 18 years and older by submitting these data. However, the company did not provide any timeline for the filing.
The NYSE ARCA Pharmaceutical Index declined 0.84% 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, AstraZeneca was the highest gainer (7.2%), while Novartis declined the most (7.5%).
In the past six months, Lilly has risen the highest (24.7%), while Pfizer has declined the most (18.0%).
(See the last pharma stock roundup here: AZN Voydeya Gets FDA Nod, MRK KRAS Inhibitor Enters Phase III)
What's Next in the Pharma World?
Watch for regular pipeline and regulatory updates next week.
Pfizer, Merck and J&J have a Zacks Rank #3 (Hold) each, while Shockwave Medical has a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.