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Pharma Stock Roundup: JNJ, NVS Upbeat Q2 Results, FDA Nod to SNY & AZN RSV Antibody
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This week, J&J (JNJ - Free Report) and Novartis (NVS - Free Report) announced better-than-expected second-quarter earnings and raised their financial outlook for the year. The FDA approved AstraZeneca (AZN - Free Report) /Sanofi’s (SNY - Free Report) RSV antibody, Beyfortus (nirsevimab) to protect infants from the virus. Eli Lilly (LLY - Free Report) announced a definitive agreement to acquire private biotech Versanis, which is expected to strengthen its position in the obesity market.
Recap of the Week’s Most Important Stories
J&J and Novartis Announce Q2 Earnings: J&J reported strong second-quarter results, beating estimates for earnings as well as sales. The company’s strong performance in the first half of the year led it to raise its financial guidance for the second time this year. MedTech segment sales were particularly strong. The Pharmaceuticals segment also continued its strong sales performance. Pharmaceutical segment sales rose 3.1% year over year to $13.73 billion. MedTech segment sales came in at $7.79 billion, up 12.9% from the year-ago period.
Novartis beat estimates for both earnings and sales. Sales in the Innovative Medicines unit rose 7% at constant currency, driven by the continued strong performance of Entresto, Pluvicto, Kesimpta and Kisqali, partly offset by generic competition, mainly for Gilenya. Sales in the Sandoz division rose 8%, driven by a strong performance in Europe. The planned spin-off of the Sandoz unit remains on track in the early fourth quarter of 2023. The company raised its financial guidance for 2023. Sales are now expected to grow in the high-single-digit range, up from the previous guidance of a mid-single-digit range. Core operating income is now projected to grow in the low double digits range, up from the previous guidance of a high single-digit range.
FDA Approves AstraZeneca/Sanofi’s RSV Antibody for Infants: Sanofi along with partner AstraZeneca announced that the FDA has approved its respiratory syncytial virus (“RSV”) antibody Beyfortus (nirsevimab) to protect newborns and infants. Beyfortus has been approved for the prevention of RSV lower respiratory tract disease (LRTD) in newborns and infants born during or entering their first RSV season, and for children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season.
The approval was expected as last month the FDA’s Antimicrobial Drugs Advisory Committee had voted unanimously (21-0), recommending approval of Beyfortus as the first full immunization against RSV disease for all infants. AstraZeneca/Sanofi expect to launch Beyfortus in the country ahead of the upcoming 2023/2024 RSV season. Beyfortus was authorized in the European Union last November to prevent RSV-induced LRTD in newborns and infants during their first RSV season.
Lilly to Buy Private Drugmaker to Boost Obesity Pipeline: Lilly announced a definitive agreement to acquire private biotech Versanis for up to $1.93 billion. The acquisition is expected to boost Lilly’s position in the obesity market. Versanis’ lead pipeline candidate is bimagrumab, a monoclonal antibody, being developed in a phase IIb study alone and in combination with Novo Nordisk’s semaglutide in adults who are overweight or obese. Bimagrumab has the potential to show better-quality weight loss by reducing fat mass while preserving muscle mass in people who are obese or have obesity-related complications. In a previous phase II study, bimagrumab resulted in a placebo-adjusted fat mass loss of approximately 22% coupled with 4.5% lean mass gain, despite minimal change in caloric intake.
Lilly presented full data from the TRAILBLAZER-ALZ 2 phase III study of donanemab at the Alzheimer's Association International Conference. In May, Lilly had announced top-line data from the TRAILBLAZER-ALZ 2 study on donanemab. The data confirmed that treatment with donanemab significantly slowed cognitive and functional decline in early symptomatic Alzheimer's disease patients. The latest data showed that almost 47% of the patients at earlier stage of disease treated with donanemab had no clinical progression at 1 year compared with 29% on placebo. In patients with the earliest stage of the disease, an even greater benefit was observed, with a 60% slowing of decline compared to placebo.
Based on data from the TRAILBLAZER-ALZ 2 study, Eli Lilly has completed filing with the FDA for traditional approval. A final decision from the agency is expected before the year-end.
J&J’s Top Line Data from Rybrevant Study in Newly Diagnosed NSCLC: J&J announced positive top-line data from the phase III PAPILLON study, which evaluated Rybrevant in combination with chemotherapy (carboplatin-pemetrexed) in patients with newly diagnosed advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations.
At present, Rybrevant is approved for locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations whose disease has progressed on or after platinum-based chemotherapy. PAPILLON is a confirmatory study for this accelerated approval. The study met its primary endpoint. It showed a statistically significant and clinically meaningful improvement in progression-free survival in the Rybrevant plus chemotherapy arm versus chemotherapy alone
The NYSE ARCA Pharmaceutical Index rose 4.33% in the last five trading sessions.
Image: Bigstock
Pharma Stock Roundup: JNJ, NVS Upbeat Q2 Results, FDA Nod to SNY & AZN RSV Antibody
This week, J&J (JNJ - Free Report) and Novartis (NVS - Free Report) announced better-than-expected second-quarter earnings and raised their financial outlook for the year. The FDA approved AstraZeneca (AZN - Free Report) /Sanofi’s (SNY - Free Report) RSV antibody, Beyfortus (nirsevimab) to protect infants from the virus. Eli Lilly (LLY - Free Report) announced a definitive agreement to acquire private biotech Versanis, which is expected to strengthen its position in the obesity market.
Recap of the Week’s Most Important Stories
J&J and Novartis Announce Q2 Earnings: J&J reported strong second-quarter results, beating estimates for earnings as well as sales. The company’s strong performance in the first half of the year led it to raise its financial guidance for the second time this year. MedTech segment sales were particularly strong. The Pharmaceuticals segment also continued its strong sales performance. Pharmaceutical segment sales rose 3.1% year over year to $13.73 billion. MedTech segment sales came in at $7.79 billion, up 12.9% from the year-ago period.
Novartis beat estimates for both earnings and sales. Sales in the Innovative Medicines unit rose 7% at constant currency, driven by the continued strong performance of Entresto, Pluvicto, Kesimpta and Kisqali, partly offset by generic competition, mainly for Gilenya. Sales in the Sandoz division rose 8%, driven by a strong performance in Europe. The planned spin-off of the Sandoz unit remains on track in the early fourth quarter of 2023. The company raised its financial guidance for 2023. Sales are now expected to grow in the high-single-digit range, up from the previous guidance of a mid-single-digit range. Core operating income is now projected to grow in the low double digits range, up from the previous guidance of a high single-digit range.
FDA Approves AstraZeneca/Sanofi’s RSV Antibody for Infants: Sanofi along with partner AstraZeneca announced that the FDA has approved its respiratory syncytial virus (“RSV”) antibody Beyfortus (nirsevimab) to protect newborns and infants. Beyfortus has been approved for the prevention of RSV lower respiratory tract disease (LRTD) in newborns and infants born during or entering their first RSV season, and for children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season.
The approval was expected as last month the FDA’s Antimicrobial Drugs Advisory Committee had voted unanimously (21-0), recommending approval of Beyfortus as the first full immunization against RSV disease for all infants. AstraZeneca/Sanofi expect to launch Beyfortus in the country ahead of the upcoming 2023/2024 RSV season. Beyfortus was authorized in the European Union last November to prevent RSV-induced LRTD in newborns and infants during their first RSV season.
Lilly to Buy Private Drugmaker to Boost Obesity Pipeline: Lilly announced a definitive agreement to acquire private biotech Versanis for up to $1.93 billion. The acquisition is expected to boost Lilly’s position in the obesity market. Versanis’ lead pipeline candidate is bimagrumab, a monoclonal antibody, being developed in a phase IIb study alone and in combination with Novo Nordisk’s semaglutide in adults who are overweight or obese. Bimagrumab has the potential to show better-quality weight loss by reducing fat mass while preserving muscle mass in people who are obese or have obesity-related complications. In a previous phase II study, bimagrumab resulted in a placebo-adjusted fat mass loss of approximately 22% coupled with 4.5% lean mass gain, despite minimal change in caloric intake.
Lilly presented full data from the TRAILBLAZER-ALZ 2 phase III study of donanemab at the Alzheimer's Association International Conference. In May, Lilly had announced top-line data from the TRAILBLAZER-ALZ 2 study on donanemab. The data confirmed that treatment with donanemab significantly slowed cognitive and functional decline in early symptomatic Alzheimer's disease patients. The latest data showed that almost 47% of the patients at earlier stage of disease treated with donanemab had no clinical progression at 1 year compared with 29% on placebo. In patients with the earliest stage of the disease, an even greater benefit was observed, with a 60% slowing of decline compared to placebo.
Based on data from the TRAILBLAZER-ALZ 2 study, Eli Lilly has completed filing with the FDA for traditional approval. A final decision from the agency is expected before the year-end.
J&J’s Top Line Data from Rybrevant Study in Newly Diagnosed NSCLC: J&J announced positive top-line data from the phase III PAPILLON study, which evaluated Rybrevant in combination with chemotherapy (carboplatin-pemetrexed) in patients with newly diagnosed advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations.
At present, Rybrevant is approved for locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations whose disease has progressed on or after platinum-based chemotherapy. PAPILLON is a confirmatory study for this accelerated approval. The study met its primary endpoint. It showed a statistically significant and clinically meaningful improvement in progression-free survival in the Rybrevant plus chemotherapy arm versus chemotherapy alone
The NYSE ARCA Pharmaceutical Index rose 4.33% 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 (up 6.8%), while AstraZeneca declined the most (8.2%).
In the past six months, Lilly has risen the most (35.5%), while Pfizer has declined the most (18.2%).
What's Next in the Pharma World?
Watch out for earnings updates from AstraZeneca, Sanofi and AbbVie and regular pipeline and regulatory updates next week.