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Pharma Stock Roundup: LLY, NVS, AZN's Q3 Earnings, Updates From FDA
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This week Lilly (LLY - Free Report) , Novartis (NVS - Free Report) and AstraZeneca (AZN - Free Report) released their third-quarter results. Bristol-Myers (BMY - Free Report) and Roche’s (RHHBY - Free Report) PD-L1 inhibitors, Opdivo and Tecentriq, respectively, met their goals in label expansion cancer studies. Meanwhile, the FDA granted approval to Glaxo’s (GSK - Free Report) PARP inhibitor Zejula, AstraZeneca’s SGLT2 inhibitor Farxiga and J&J’s (JNJ - Free Report) blockbuster immunology medicine, Stelara for expanded patient populations. The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) gave positive recommendations, granting marketing approval to several drugs or their line extensions this week.
Recap of the Week’s Most Important Stories
Earnings Update: Lilly beat estimates for third-quarter earnings but missed the same for sales. Earnings rose 10% year over year while sales grew 3% year over year, backed by strong volume trends for its newer drugs, which compensated for lower sales of older products like Cialis due to the loss of U.S. exclusivity and the impact of Lartruvo’s product withdrawal. Lilly raised its expectations for full-year earnings while keeping its revenue guidance intact.
Novartis’ earnings and sales beat estimates in the third quarter. It expects to achieve the higher end of its previously provided sales growth target for the year. The company expects net sales in 2019 to grow in high-single digits now compared with the previous guidance of mid-to-high-single-digit growth.
AstraZeneca also beat estimates on both counts. Its product sales rose 18% as higher sales of newer medicines offset lower sales of many other legacy medicines. The company updated its product sales guidance and now expects it to grow by a low to mid-teens percentage versus prior expectation of a low double-digit percentage.
Bristol-Myers Opdivo Combo Meets Goal in First-Line Lung Cancer Study: Bristol-Myers’ phase III study evaluating a combination of Opdivo plus low-dose Yervoy combined with two courses of chemotherapy for the first-line treatment of advanced non-small cell lung cancer met the primary endpoint. Interim data from the pivotal CheckMate -9LA study showed that the combination led to superior overall survival (OS) compared to chemotherapy alone in previously untreated lung cancer patients.
Meanwhile, the European Commission approved Opdivo two and four-week flat dosing schedule for the adjuvant treatment of melanoma patients with involvement of lymph nodes or metastatic disease who have undergone complete resection
FDA Approves Glaxo’s Zejula for Late-Line Ovarian Cancer: Zejula, the ovarian cancer drug Glaxo acquired from the Tesaro acquisition, was approved by the FDA for ovarian cancer patients who are HRD-positive and have been treated with three or more previous chemotherapy regimen. This is the first time a PARP inhibitor (as a monotherapy) has been approved in patients beyond those with a BRCA-positive mutation. The approval in this late-line setting is based on data from the phase II QUADRA study.
Glaxo also announced that it is divesting its vaccines to prevent rabies (Rabipur/Rabavert) and tick-borne encephalitis (Encepur) to Bavarian Nordic, a Danish biotech, for an upfront payment of approximately EUR301 million (£259m). In addition, Glaxo will also be entitled to receive milestone payments for a total consideration of up to EUR955 million (£822m). Glaxo acquired these vaccines from Novartis in 2015 as part of the acquisition of its vaccines business.
FDA Approves AstraZeneca’s Farxiga to Reduce Heart Risk: AstraZeneca announced that the FDA has approved inclusion of positive cardiovascular outcomes from the DECLARE outcomes study on the label of its SGLT2 inhibitor, Farxiga. With the latest nod, Farxiga can now be prescribed in the United States to reduce the risk of hospitalization for heart failure in patients with type-II diabetes and established cardiovascular disease or multiple cardiovascular risk factors. An approval for a similar label update was obtained in the EU in August.
Roche’s Cancer Combo Improves Survival in Liver Cancer Study: Roche’s phase III IMbrave150 study, which evaluated Tecentriq in combination with Avastin in patients with unresectable hepatocellular carcinoma, the most common form of liver cancer, met both its co-primary endpoints. The study demonstrated statistically significant and clinically meaningful improvements in OS and progression-free survival (PFS) – the co-primary endpoints - compared with standard-of-care, Bayer’s Nexavar (sorafenib). Roche will submit the data to regulatory authorities in the United States, Europe and China to get approval for this new indication of Tecentriq.
FDA Finds Asbestos in One Lot of J&J’s Baby Powders; J&J Recalls: J&J announced a voluntary recall of one lot of its Johnson’s Baby Powder. The product is the subject of numerous lawsuits, which claim that its talc-based products contain asbestos that causes cancer. The recall was initiated following a test done by the FDA, which revealed traces of asbestos, a known carcinogen, in samples from one bottle purchased online. J&J affirmed that its cosmetic talc is safe and said that it has initiated an investigation into the matter. The FDA, on the other hand, said its stands by the quality of its testing and advised the consumers to stop using the recalled/affected products.
Meanwhile, the FDA granted approval to J&J’s blockbuster immunology medicine, Stelara for a new indication - moderately to severely active ulcerative colitis. The approval was based on data from the phase III UNIFI study.
J&J also announced new data from a study evaluating the initial combination therapy with Opsumit (macitentan) and tadalafil in patients with pulmonary arterial hypertension. The data showed that patients treated with the combination regimen experienced hemodynamic improvement, as well as improvements in functional parameters and risk profiles. In the study, Opsumit plus tadalafIl, reduced the primary endpoint of mean pulmonary vascular resistance by 47% at week 16 compared with baseline.
FDA Approves 11th Therapeutic Indication for Allergan’s Botox: The FDA approved Allergan’s blockbuster product Botox for pediatric patients (2 to 17 years of age) with lower limb spasticity, excluding spasticity caused by cerebral palsy. In June, Botox was approved to treat upper limb spasticity in pediatric patients. Botox is already approved for both lower and upper limb spasticity in adults.
CHMP Nod to Several Products: The CHMP gave a positive opinion recommending conditional marketing approval of Merck’s investigational vaccine for Ebola Zaire disease, V920. If approved by the European Commission, V920will be marketed by the trade name of Ervebo. Ervebo is under priority review in the United States with a FDA decision expected on Mar 14 next year.
The CHMP also recommended approval of two new regimens of Keytruda for the first-line treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC). The application seeks approval of Keytruda as a monotherapy or in combination with platinum and 5-fluorouracil (5-FU) chemotherapy. Keytruda was approved for a similar indication in the United States in June this year.
The European panel also recommended approving AbbVie’s oral JAK1-selective inhibitor, Rinvoq (upadacitinib) for moderate-to-severe active rheumatoid arthritis and J&J’s Spravato (esketamine) nasal spray as a combination therapy for adults with major depressive disorder. While Rinvoq was approved by the FDA in August, Spravato got the green signal from the regulatory body in March.
The NYSE ARCA Pharmaceutical Index declined 0.5% in the last five trading sessions.
Watch out for third quarter results of Bristol-Myers, Merck, Pfizer, AbbVie and others and regular pipeline and regulatory updates next week.
5 Stocks Set to Double
Each was hand-picked by a Zacks expert as the #1 favorite stock to gain +100% or more in 2020. Each comes from a different sector and has unique qualities and catalysts that could fuel exceptional growth.
Most of the stocks in this report are flying under Wall Street radar, which provides a great opportunity to get in on the ground floor.
Image: Bigstock
Pharma Stock Roundup: LLY, NVS, AZN's Q3 Earnings, Updates From FDA
This week Lilly (LLY - Free Report) , Novartis (NVS - Free Report) and AstraZeneca (AZN - Free Report) released their third-quarter results. Bristol-Myers (BMY - Free Report) and Roche’s (RHHBY - Free Report) PD-L1 inhibitors, Opdivo and Tecentriq, respectively, met their goals in label expansion cancer studies. Meanwhile, the FDA granted approval to Glaxo’s (GSK - Free Report) PARP inhibitor Zejula, AstraZeneca’s SGLT2 inhibitor Farxiga and J&J’s (JNJ - Free Report) blockbuster immunology medicine, Stelara for expanded patient populations. The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) gave positive recommendations, granting marketing approval to several drugs or their line extensions this week.
Recap of the Week’s Most Important Stories
Earnings Update: Lilly beat estimates for third-quarter earnings but missed the same for sales. Earnings rose 10% year over year while sales grew 3% year over year, backed by strong volume trends for its newer drugs, which compensated for lower sales of older products like Cialis due to the loss of U.S. exclusivity and the impact of Lartruvo’s product withdrawal. Lilly raised its expectations for full-year earnings while keeping its revenue guidance intact.
Novartis’ earnings and sales beat estimates in the third quarter. It expects to achieve the higher end of its previously provided sales growth target for the year. The company expects net sales in 2019 to grow in high-single digits now compared with the previous guidance of mid-to-high-single-digit growth.
AstraZeneca also beat estimates on both counts. Its product sales rose 18% as higher sales of newer medicines offset lower sales of many other legacy medicines. The company updated its product sales guidance and now expects it to grow by a low to mid-teens percentage versus prior expectation of a low double-digit percentage.
Bristol-Myers Opdivo Combo Meets Goal in First-Line Lung Cancer Study: Bristol-Myers’ phase III study evaluating a combination of Opdivo plus low-dose Yervoy combined with two courses of chemotherapy for the first-line treatment of advanced non-small cell lung cancer met the primary endpoint. Interim data from the pivotal CheckMate -9LA study showed that the combination led to superior overall survival (OS) compared to chemotherapy alone in previously untreated lung cancer patients.
Meanwhile, the European Commission approved Opdivo two and four-week flat dosing schedule for the adjuvant treatment of melanoma patients with involvement of lymph nodes or metastatic disease who have undergone complete resection
FDA Approves Glaxo’s Zejula for Late-Line Ovarian Cancer: Zejula, the ovarian cancer drug Glaxo acquired from the Tesaro acquisition, was approved by the FDA for ovarian cancer patients who are HRD-positive and have been treated with three or more previous chemotherapy regimen. This is the first time a PARP inhibitor (as a monotherapy) has been approved in patients beyond those with a BRCA-positive mutation. The approval in this late-line setting is based on data from the phase II QUADRA study.
Glaxo also announced that it is divesting its vaccines to prevent rabies (Rabipur/Rabavert) and tick-borne encephalitis (Encepur) to Bavarian Nordic, a Danish biotech, for an upfront payment of approximately EUR301 million (£259m). In addition, Glaxo will also be entitled to receive milestone payments for a total consideration of up to EUR955 million (£822m). Glaxo acquired these vaccines from Novartis in 2015 as part of the acquisition of its vaccines business.
FDA Approves AstraZeneca’s Farxiga to Reduce Heart Risk: AstraZeneca announced that the FDA has approved inclusion of positive cardiovascular outcomes from the DECLARE outcomes study on the label of its SGLT2 inhibitor, Farxiga. With the latest nod, Farxiga can now be prescribed in the United States to reduce the risk of hospitalization for heart failure in patients with type-II diabetes and established cardiovascular disease or multiple cardiovascular risk factors. An approval for a similar label update was obtained in the EU in August.
Roche’s Cancer Combo Improves Survival in Liver Cancer Study: Roche’s phase III IMbrave150 study, which evaluated Tecentriq in combination with Avastin in patients with unresectable hepatocellular carcinoma, the most common form of liver cancer, met both its co-primary endpoints. The study demonstrated statistically significant and clinically meaningful improvements in OS and progression-free survival (PFS) – the co-primary endpoints - compared with standard-of-care, Bayer’s Nexavar (sorafenib). Roche will submit the data to regulatory authorities in the United States, Europe and China to get approval for this new indication of Tecentriq.
FDA Finds Asbestos in One Lot of J&J’s Baby Powders; J&J Recalls: J&J announced a voluntary recall of one lot of its Johnson’s Baby Powder. The product is the subject of numerous lawsuits, which claim that its talc-based products contain asbestos that causes cancer. The recall was initiated following a test done by the FDA, which revealed traces of asbestos, a known carcinogen, in samples from one bottle purchased online. J&J affirmed that its cosmetic talc is safe and said that it has initiated an investigation into the matter. The FDA, on the other hand, said its stands by the quality of its testing and advised the consumers to stop using the recalled/affected products.
Meanwhile, the FDA granted approval to J&J’s blockbuster immunology medicine, Stelara for a new indication - moderately to severely active ulcerative colitis. The approval was based on data from the phase III UNIFI study.
J&J also announced new data from a study evaluating the initial combination therapy with Opsumit (macitentan) and tadalafil in patients with pulmonary arterial hypertension. The data showed that patients treated with the combination regimen experienced hemodynamic improvement, as well as improvements in functional parameters and risk profiles. In the study, Opsumit plus tadalafIl, reduced the primary endpoint of mean pulmonary vascular resistance by 47% at week 16 compared with baseline.
FDA Approves 11th Therapeutic Indication for Allergan’s Botox: The FDA approved Allergan’s blockbuster product Botox for pediatric patients (2 to 17 years of age) with lower limb spasticity, excluding spasticity caused by cerebral palsy. In June, Botox was approved to treat upper limb spasticity in pediatric patients. Botox is already approved for both lower and upper limb spasticity in adults.
CHMP Nod to Several Products: The CHMP gave a positive opinion recommending conditional marketing approval of Merck’s investigational vaccine for Ebola Zaire disease, V920. If approved by the European Commission, V920will be marketed by the trade name of Ervebo. Ervebo is under priority review in the United States with a FDA decision expected on Mar 14 next year.
The CHMP also recommended approval of two new regimens of Keytruda for the first-line treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC). The application seeks approval of Keytruda as a monotherapy or in combination with platinum and 5-fluorouracil (5-FU) chemotherapy. Keytruda was approved for a similar indication in the United States in June this year.
The European panel also recommended approving AbbVie’s oral JAK1-selective inhibitor, Rinvoq (upadacitinib) for moderate-to-severe active rheumatoid arthritis and J&J’s Spravato (esketamine) nasal spray as a combination therapy for adults with major depressive disorder. While Rinvoq was approved by the FDA in August, Spravato got the green signal from the regulatory body in March.
The NYSE ARCA Pharmaceutical Index declined 0.5% in the last five trading sessions.
Large Cap Pharmaceuticals Industry 5YR % Return
Large Cap Pharmaceuticals Industry 5YR % Return
Here is how the seven major stocks performed in the last five trading sessions.
Last week, while J&J lost the most (6.6%) due to the baby powder recall news, AstraZeneca was the biggest gainer (7%) due to strong results.
In the past six months, AstraZeneca has risen the most (24.4%) while Lilly lost the most (10%).
(See the last pharma stock roundup here: JNJ’s Q3 Earnings, RHHBY’s Sales, FDA Nod to Lilly’s Reyvow).
What's Next in the Pharma World?
Watch out for third quarter results of Bristol-Myers, Merck, Pfizer, AbbVie and others and regular pipeline and regulatory updates next week.
5 Stocks Set to Double
Each was hand-picked by a Zacks expert as the #1 favorite stock to gain +100% or more in 2020. Each comes from a different sector and has unique qualities and catalysts that could fuel exceptional growth.
Most of the stocks in this report are flying under Wall Street radar, which provides a great opportunity to get in on the ground floor.
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