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Pharma Stock Roundup: JNJ Q4 Results Mixed, MRK Keytruda Prostate Cancer Study Ends
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This week, J&J (JNJ - Free Report) began the fourth-quarter earnings season for the drug and biotech sector with mixed results. Merck (MRK - Free Report) said it is stopping an advanced prostate cancer study on blockbuster drug Keytruda for futility. The FDA accepted Eli Lilly’s (LLY - Free Report) filing seeking approval for the expanded use of its diabetes medicine, Jardiance, for chronic kidney disease (CKD) indication. Novartis’ (NVS - Free Report) subsidiary, Sandoz announced an agreement to acquire worldwide product rights of the leading systemic antifungal agent Mycamine from Astellas. The FDA withdrew the emergency-use authorization for AstraZeneca's (AZN - Free Report) COVID-19 antibody cocktail, Evusheld.
Recap of the Week’s Most Important Stories
J&J’s Mixed Q4 Results: J&J reported mixed fourth-quarter results as it beat estimates for earnings but missed the same for sales. Currency headwinds reduced its total sales by more than 5% in the quarter. Sales declined 4.4% from the year-ago quarter, reflecting an operational increase of 0.9% and a negative currency impact of 5.3%.
Overall, macroeconomic challenges and lingering COVID-related impacts hurt fourth-quarter sales growth. While the Pharmaceuticals unit continued to post above-market adjusted operational sales growth, sales slowed down in the fourth quarter. COVID resurgence in China and supply constraints hurt sales in the MedTech and Consumer Health segments.
The company’s profit outlook for 2023 was above analyst expectations, while the sales outlook was below estimates.
Merck Stops Keytruda Prostate Cancer Study: Merck announced that it is discontinuing a phase III study evaluating Keytruda in combination with enzalutamide and androgen deprivation therapy (ADT) for the treatment of patients with metastatic hormone-sensitive prostate cancer. The decision to stop the study was based on the recommendation of an independent Data Monitoring Committee (DMC) following an interim review of the study’s (KEYNOTE-991) data. The interim analysis by DMC revealed that the Keytruda combination failed to show an improvement in overall survival or radiographic progression-free survival, the trial’s dual primary endpoints, compared to placebo plus enzalutamide and ADT.
FDA Accepts Lilly’s Jardiance sNDA: The FDA accepted Lilly and partner Boehringer Ingelheim’s supplemental new drug application (sNDA) seeking approval of its SGLT-2 inhibitor Jardiance (empagliflozin) to reduce the risk of kidney disease progression and cardiovascular death in adults with chronic kidney disease indication. The sNDA was based on data from the EMPA-KIDNEY phase III study. Other than type II diabetes, Jardiance is also approved to reduce cardiovascular death in adults with type II diabetes and known cardiovascular disease. Jardiance was approved for chronic heart failure in people with reduced left ventricular ejection fraction (LVEF) and for heart failure with preserved LVEF indication in 2021/2022.
Novartis’ Sandoz Buying Rights to Astellas’ Antibiotic: Novartis’ generic subsidiary, Sandoz announced plans to acquire worldwide product rights to Japan’s Astellas antifungal agent, Mycamine (micafungin sodium). Mycamine is a leading global echinocandin approved for treating invasive candidiasis and esophageal candidiasis. The acquisition, expected to close in the first half of 2023, is expected to strengthen Sandoz’s global hospital offering and anti-infective portfolio.
FDA Withdraws AstraZeneca’s COVID Drug Authorization: The FDA withdrew the Emergency Use Authorization granted to AstraZeneca’s Evusheld for pre-exposure prophylaxis of COVID-19 in certain high-risk populations in the United States. The FDA believes the antibody cocktail medicine Evusheld does not neutralize Omicron subvariants that are in circulation presently and are responsible for 90% of COVID cases in the United States. In Europe and Japan, Evusheld is authorized for the prevention as well as treatment of COVID-19.
The European Commission approved AstraZeneca’s Enhertu for previously treated patients with unresectable or metastatic HER2-low metastatic breast cancer.
Enhertu is the first-ever HER2-directed medicine to demonstrate a significant survival benefit for the treatment of patients with HER2-low metastatic breast cancer with both HR-positive and HR-negative disease. The approval was based on data from the pivotal phase III DESTINY-Breast04 study. In the study, Enhertu reduced the risk of disease progression or death by 50% and increased overall survival by more than six months versus chemotherapy. The FDA approved Enhertu for the same patient population in August.
The NYSE ARCA Pharmaceutical Index declined 1.5% in the last five trading sessions.
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, AbbVie rose the most (0.6%), while AstraZeneca declined the most (1.9%).
In the past six months, Merck has risen the most (18.9%), while Pfizer declined the most (12.7%).
Image: Bigstock
Pharma Stock Roundup: JNJ Q4 Results Mixed, MRK Keytruda Prostate Cancer Study Ends
This week, J&J (JNJ - Free Report) began the fourth-quarter earnings season for the drug and biotech sector with mixed results. Merck (MRK - Free Report) said it is stopping an advanced prostate cancer study on blockbuster drug Keytruda for futility. The FDA accepted Eli Lilly’s (LLY - Free Report) filing seeking approval for the expanded use of its diabetes medicine, Jardiance, for chronic kidney disease (CKD) indication. Novartis’ (NVS - Free Report) subsidiary, Sandoz announced an agreement to acquire worldwide product rights of the leading systemic antifungal agent Mycamine from Astellas. The FDA withdrew the emergency-use authorization for AstraZeneca's (AZN - Free Report) COVID-19 antibody cocktail, Evusheld.
Recap of the Week’s Most Important Stories
J&J’s Mixed Q4 Results: J&J reported mixed fourth-quarter results as it beat estimates for earnings but missed the same for sales. Currency headwinds reduced its total sales by more than 5% in the quarter. Sales declined 4.4% from the year-ago quarter, reflecting an operational increase of 0.9% and a negative currency impact of 5.3%.
Overall, macroeconomic challenges and lingering COVID-related impacts hurt fourth-quarter sales growth. While the Pharmaceuticals unit continued to post above-market adjusted operational sales growth, sales slowed down in the fourth quarter. COVID resurgence in China and supply constraints hurt sales in the MedTech and Consumer Health segments.
The company’s profit outlook for 2023 was above analyst expectations, while the sales outlook was below estimates.
Merck Stops Keytruda Prostate Cancer Study: Merck announced that it is discontinuing a phase III study evaluating Keytruda in combination with enzalutamide and androgen deprivation therapy (ADT) for the treatment of patients with metastatic hormone-sensitive prostate cancer. The decision to stop the study was based on the recommendation of an independent Data Monitoring Committee (DMC) following an interim review of the study’s (KEYNOTE-991) data. The interim analysis by DMC revealed that the Keytruda combination failed to show an improvement in overall survival or radiographic progression-free survival, the trial’s dual primary endpoints, compared to placebo plus enzalutamide and ADT.
FDA Accepts Lilly’s Jardiance sNDA: The FDA accepted Lilly and partner Boehringer Ingelheim’s supplemental new drug application (sNDA) seeking approval of its SGLT-2 inhibitor Jardiance (empagliflozin) to reduce the risk of kidney disease progression and cardiovascular death in adults with chronic kidney disease indication. The sNDA was based on data from the EMPA-KIDNEY phase III study. Other than type II diabetes, Jardiance is also approved to reduce cardiovascular death in adults with type II diabetes and known cardiovascular disease. Jardiance was approved for chronic heart failure in people with reduced left ventricular ejection fraction (LVEF) and for heart failure with preserved LVEF indication in 2021/2022.
Novartis’ Sandoz Buying Rights to Astellas’ Antibiotic: Novartis’ generic subsidiary, Sandoz announced plans to acquire worldwide product rights to Japan’s Astellas antifungal agent, Mycamine (micafungin sodium). Mycamine is a leading global echinocandin approved for treating invasive candidiasis and esophageal candidiasis. The acquisition, expected to close in the first half of 2023, is expected to strengthen Sandoz’s global hospital offering and anti-infective portfolio.
FDA Withdraws AstraZeneca’s COVID Drug Authorization: The FDA withdrew the Emergency Use Authorization granted to AstraZeneca’s Evusheld for pre-exposure prophylaxis of COVID-19 in certain high-risk populations in the United States. The FDA believes the antibody cocktail medicine Evusheld does not neutralize Omicron subvariants that are in circulation presently and are responsible for 90% of COVID cases in the United States. In Europe and Japan, Evusheld is authorized for the prevention as well as treatment of COVID-19.
The European Commission approved AstraZeneca’s Enhertu for previously treated patients with unresectable or metastatic HER2-low metastatic breast cancer.
Enhertu is the first-ever HER2-directed medicine to demonstrate a significant survival benefit for the treatment of patients with HER2-low metastatic breast cancer with both HR-positive and HR-negative disease. The approval was based on data from the pivotal phase III DESTINY-Breast04 study. In the study, Enhertu reduced the risk of disease progression or death by 50% and increased overall survival by more than six months versus chemotherapy. The FDA approved Enhertu for the same patient population in August.
The NYSE ARCA Pharmaceutical Index declined 1.5% in the last five trading sessions.
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, AbbVie rose the most (0.6%), while AstraZeneca declined the most (1.9%).
In the past six months, Merck has risen the most (18.9%), while Pfizer declined the most (12.7%).
(See the last pharma stock roundup here :LLY’s Donanemab Gets FDA’s CRL, MRNA RSV Jab Study Succeeds)
What's Next in the Pharma World?
Watch out for Q4 results of Pfizer, Novo Nordisk, Merck, Lilly and Sanofi and regular pipeline and regulatory updates next week.