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This week, Novartis (NVS - Free Report) and Merck (MRK - Free Report) announced their third-quarter earnings. The FDA approved J&J’s (JNJ - Free Report) Tecvayli for relapsed or refractory multiple myeloma and AstraZeneca’s (AZN - Free Report) combination of Imjudo and Imfinzi for a liver cancer indication. An FDA advisory committee backed GSK’s (GSK - Free Report) daprodustat to treat anemia in patients with chronic kidney disease (CKD) but only for patients on dialysis.
Recap of the Week’s Most Important Stories
Merck and Novartis’ Q3 Earnings: Merck’s third-quarter results were better than expected, as it beat estimates for both earnings and sales. An ongoing recovery from the disruptions related to the pandemic and strong global underlying demand across its business, particularly for Keytruda and Gardasil, led to improved sales in the quarter. Sales of Keytruda, the largest product in Merck’s portfolio, rose 20% year over year. Sales of HPV vaccines — Gardasil and Gardasil 9 — rose 15% year over year. Merck also slightly upped its sales and earnings expectations for the year.
Novartis’ third-quarter results were mixed. It missed estimates for earnings while beating the same for revenues. Sales in Innovative Medicines rose 4% at constant currency, driven by the strong growth of Entresto, Kesimpta, Cosentyx and Kisqali. Sales in the Sandoz division also rose 4%, driven by continued growth in biopharmaceuticals. The company maintained its guidance for sales and core operating income to grow in the mid-single-digit range in 2022 while increasing its guidance for Sandoz sales growth to low to mid-single digit from low single digit.
FDA Approves J&J’s Multiple Myeloma Drug, Tecvayli: J&J announced that the FDA has granted accelerated approval to Tecvayli (teclistamab) as monotherapy for the treatment of patients with relapsed and refractory multiple myeloma. Tecvayli’s approval was based on data from the phase I/II MajesTEC-1 study, which showed that treatment with teclistamab resulted in deep and durable responses. Tecvayli was approved in Europe in August.
FDA Nod to AstraZeneca’s Imfinzi/Imjudo Combo for Liver Cancer: The FDA approved AstraZeneca’s Imfinzi in combination with Imjudo (tremelimumab) for patients with unresectable hepatocellular carcinoma (HCC), the most common type of liver cancer. The approval for this novel dose and schedule of the combination of an anti-CTLA-4 antibody, Imjudo and a PD-L1 inhibitor, Imfinzi, is based on positive data from the HIMALAYA phase III study. Data from this study showed that a single priming dose of Imjudo added to Imfinzi reduced the risk of death by 22% versus sorafenib.
AstraZeneca’s phase III study, MESSINA, on Fasenra in eosinophilic esophagitis (EoE) failed to meet one of the two dual-primary endpoints. In the study, Fasenra demonstrated a statistically significant improvement in histological disease remission but did not show any change in dysphagia symptoms compared to placebo in patients with EoE aged 12 years or older. Fasenra is currently approved for severe eosinophilic asthma.
AstraZeneca’s pipeline candidate, capivasertib, a potential first-in-class AKT inhibitor, combined with a breast cancer drug, Faslodex, significantly demonstrated a statistically significant and a clinically meaningful improvement in progression-free survival (PFS) versus placebo plus Faslodex in the CAPItello-291 phase III study in advanced HR-positive breast cancer. The study met both primary endpoints, improving PFS in the overall patient population and in a prespecified biomarker subgroup of patients whose tumors had qualifying alterations in the PIK3CA, AKT1 or PTEN genes.
AstraZeneca’s another pipeline candidate, camizestrant, a next-generation oral SERD met the primary endpoint of demonstrating a statistically significant and clinically meaningful improvement in PFS for both doses (75mg and 150mg ) versus Faslodex (500mg) in patients with advanced ER-positive breast cancer in the SERENA-2 phase II study.
FDA Panel’s Mixed Opinion on GSK’s Daprodustat’s NDA: The FDA’s Cardiovascular and Renal Drugs Advisory Committee (CRDAC) gave a mixed opinion on the NDA seeking approval of GSK’s daprodustat for anemia of chronic kidney disease (CKD). The panel voted 13-3 in favor of daprodustat’s treatment benefits outweighing the risks in adult dialysis patients with anemia of CKD. However, for adult non-dialysis patients with anemia of CKD, the committee voted 5-11 against the benefits outweighing the risks. The FDA is not bound by the Committee’s recommendation, though it usually follows its opinion. The FDA’s decision on daprodustat’s NDA is expected on Feb 1, 2023. Daprodustat is approved as Duvroq in Japan for the treatment of patients with anemia of CKD, while a regulatory application is also under review in Europe with a regulatory decision anticipated in the first half of 2023.
GSK’s two-phase III studies, ContRAst-1 and ContRAst-2, evaluating otilimab for the treatment of moderate-to-severe rheumatoid arthritis met the primary endpoints of a statistically significant ACR20 response versus placebo at week 12. However, the third study in the ContRAst phase IIl program, ContRAst-3, failed to demonstrate statistical significance on the primary endpoint of ACR20 response versus placebo at week 12. All the studies were conducted in difficult-to-treat RA patients who had an inadequate response to or could not tolerate available treatments like methotrexate or conventional synthetic or biologic disease modifying antirheumatic drugs (DMARDs) or JAK inhibitors. However, though the ContRAst-1 and ContRAst-2 studies met the primary endpoints, GSK believes the limited efficacy seen does not support a suitable benefit/risk profile for otilimab as a potential treatment for RA. GSK has thus decided not to file regulatory applications for otilimab.
Merck’s Vaxneuvance Vaccine Gets Europe Approval in Kids: The European Commission approved the use of Merck’s pneumococcal 15-valent conjugate vaccine, Vaxneuvance in children six weeks to less than 18 years of age. Vaxneuvance can now be given for the prevention of invasive disease and pneumonia and acute otitis media in kids of this age group. Vaxneuvance was approved for use in adults aged 18 years and older in Europe last December to protect against invasive pneumococcal disease.
Vaxneuvance was approved in the United States for use in individuals aged six weeks and older in June 2022.
The NYSE ARCA Pharmaceutical Index rose 5.6% in the last five trading sessions.
Image: Bigstock
Pharma Stock Roundup: NVS, MRK Report Q3 Earnings JNJ's Tecvayli Gets FDA Nod
This week, Novartis (NVS - Free Report) and Merck (MRK - Free Report) announced their third-quarter earnings. The FDA approved J&J’s (JNJ - Free Report) Tecvayli for relapsed or refractory multiple myeloma and AstraZeneca’s (AZN - Free Report) combination of Imjudo and Imfinzi for a liver cancer indication. An FDA advisory committee backed GSK’s (GSK - Free Report) daprodustat to treat anemia in patients with chronic kidney disease (CKD) but only for patients on dialysis.
Recap of the Week’s Most Important Stories
Merck and Novartis’ Q3 Earnings: Merck’s third-quarter results were better than expected, as it beat estimates for both earnings and sales. An ongoing recovery from the disruptions related to the pandemic and strong global underlying demand across its business, particularly for Keytruda and Gardasil, led to improved sales in the quarter. Sales of Keytruda, the largest product in Merck’s portfolio, rose 20% year over year. Sales of HPV vaccines — Gardasil and Gardasil 9 — rose 15% year over year. Merck also slightly upped its sales and earnings expectations for the year.
Novartis’ third-quarter results were mixed. It missed estimates for earnings while beating the same for revenues. Sales in Innovative Medicines rose 4% at constant currency, driven by the strong growth of Entresto, Kesimpta, Cosentyx and Kisqali. Sales in the Sandoz division also rose 4%, driven by continued growth in biopharmaceuticals. The company maintained its guidance for sales and core operating income to grow in the mid-single-digit range in 2022 while increasing its guidance for Sandoz sales growth to low to mid-single digit from low single digit.
FDA Approves J&J’s Multiple Myeloma Drug, Tecvayli: J&J announced that the FDA has granted accelerated approval to Tecvayli (teclistamab) as monotherapy for the treatment of patients with relapsed and refractory multiple myeloma. Tecvayli’s approval was based on data from the phase I/II MajesTEC-1 study, which showed that treatment with teclistamab resulted in deep and durable responses. Tecvayli was approved in Europe in August.
FDA Nod to AstraZeneca’s Imfinzi/Imjudo Combo for Liver Cancer: The FDA approved AstraZeneca’s Imfinzi in combination with Imjudo (tremelimumab) for patients with unresectable hepatocellular carcinoma (HCC), the most common type of liver cancer. The approval for this novel dose and schedule of the combination of an anti-CTLA-4 antibody, Imjudo and a PD-L1 inhibitor, Imfinzi, is based on positive data from the HIMALAYA phase III study. Data from this study showed that a single priming dose of Imjudo added to Imfinzi reduced the risk of death by 22% versus sorafenib.
AstraZeneca’s phase III study, MESSINA, on Fasenra in eosinophilic esophagitis (EoE) failed to meet one of the two dual-primary endpoints. In the study, Fasenra demonstrated a statistically significant improvement in histological disease remission but did not show any change in dysphagia symptoms compared to placebo in patients with EoE aged 12 years or older. Fasenra is currently approved for severe eosinophilic asthma.
AstraZeneca’s pipeline candidate, capivasertib, a potential first-in-class AKT inhibitor, combined with a breast cancer drug, Faslodex, significantly demonstrated a statistically significant and a clinically meaningful improvement in progression-free survival (PFS) versus placebo plus Faslodex in the CAPItello-291 phase III study in advanced HR-positive breast cancer. The study met both primary endpoints, improving PFS in the overall patient population and in a prespecified biomarker subgroup of patients whose tumors had qualifying alterations in the PIK3CA, AKT1 or PTEN genes.
AstraZeneca’s another pipeline candidate, camizestrant, a next-generation oral SERD met the primary endpoint of demonstrating a statistically significant and clinically meaningful improvement in PFS for both doses (75mg and 150mg ) versus Faslodex (500mg) in patients with advanced ER-positive breast cancer in the SERENA-2 phase II study.
FDA Panel’s Mixed Opinion on GSK’s Daprodustat’s NDA: The FDA’s Cardiovascular and Renal Drugs Advisory Committee (CRDAC) gave a mixed opinion on the NDA seeking approval of GSK’s daprodustat for anemia of chronic kidney disease (CKD). The panel voted 13-3 in favor of daprodustat’s treatment benefits outweighing the risks in adult dialysis patients with anemia of CKD. However, for adult non-dialysis patients with anemia of CKD, the committee voted 5-11 against the benefits outweighing the risks. The FDA is not bound by the Committee’s recommendation, though it usually follows its opinion. The FDA’s decision on daprodustat’s NDA is expected on Feb 1, 2023. Daprodustat is approved as Duvroq in Japan for the treatment of patients with anemia of CKD, while a regulatory application is also under review in Europe with a regulatory decision anticipated in the first half of 2023.
GSK’s two-phase III studies, ContRAst-1 and ContRAst-2, evaluating otilimab for the treatment of moderate-to-severe rheumatoid arthritis met the primary endpoints of a statistically significant ACR20 response versus placebo at week 12. However, the third study in the ContRAst phase IIl program, ContRAst-3, failed to demonstrate statistical significance on the primary endpoint of ACR20 response versus placebo at week 12. All the studies were conducted in difficult-to-treat RA patients who had an inadequate response to or could not tolerate available treatments like methotrexate or conventional synthetic or biologic disease modifying antirheumatic drugs (DMARDs) or JAK inhibitors. However, though the ContRAst-1 and ContRAst-2 studies met the primary endpoints, GSK believes the limited efficacy seen does not support a suitable benefit/risk profile for otilimab as a potential treatment for RA. GSK has thus decided not to file regulatory applications for otilimab.
Merck’s Vaxneuvance Vaccine Gets Europe Approval in Kids: The European Commission approved the use of Merck’s pneumococcal 15-valent conjugate vaccine, Vaxneuvance in children six weeks to less than 18 years of age. Vaxneuvance can now be given for the prevention of invasive disease and pneumonia and acute otitis media in kids of this age group. Vaxneuvance was approved for use in adults aged 18 years and older in Europe last December to protect against invasive pneumococcal disease.
Vaxneuvance was approved in the United States for use in individuals aged six weeks and older in June 2022.
The NYSE ARCA Pharmaceutical Index rose 5.6% 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
All stocks rose in the last five trading sessions, with Lilly rising the most (8.3%).
In the past six months, Lilly has gained the highest (21.9%), while AstraZeneca declined the most (13.3%).
(See the last pharma stock roundup here: JNJ Q3 Earnings Beat, RHHBY Sales Weak, LLY, ABBV Ink M&A Deals)
What's Next in the Pharma World?
Watch out for Pfizer, Lilly and GSK’s Q3 earnings releases and regular pipeline and regulatory updates next week.