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Novartis Gets FDA Nod for Breast Cancer Drug & Gene Therapy
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Novartis AG (NVS - Free Report) announced that the FDA has approved Piqray (alpelisib, formerly BYL719) for breast cancer.
The drug has been approved in combination with AstraZeneca’s (AZN - Free Report) Faslodex for the treatment of postmenopausal women, and men with hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-), PIK3CA-mutated, advanced or metastatic breast cancer, as detected by an FDA-approved test following progression on or after an endocrine-based regimen.
The approval was based on results of the phase III study, SOLAR-1, which showed Piqray in combination with Faslodex nearly doubled median progression-free survival (PFS) compared to Faslodex alone in HR+/HER2- advanced breast cancer patients with a PIK3CA mutation.
The market potential for Piqray is good as PIK3CA is the most commonly mutated gene in HR+/HER2- breast cancer and approximately 40% of patients living with HR+/HER2- breast cancer have this mutation. Per Novartis, the drug is the first ever treatment developed specifically for HR+/HER2- advanced breast cancer with a PIK3CA mutation.
The approval of Piqray will further strengthen Novartis’ strong oncology portfolio, including drugs like Afinitor, Exjade, Jakavi, Zykadia, Tasigna, Luthathera, Promacta and Jadenu.
In addition, the FDA also approved Zolgensma, the first and only gene therapy for pediatric patients with spinal muscular atrophy (SMA), a rare genetic disorder. The therapy has been approved for pediatric patients less than 2 years of age. Zolgensma addresses the genetic root cause of SMA by providing a functional copy of the human SMN gene to halt disease progression through sustained SMN protein expression with a single, one-time intravenous (IV) infusion. The approval of the drug was based on data from the ongoing phase III STR1VE study.
The therapy has been priced at $2.125 million, one of the most expensive treatments. Given the high cost of the treatment, we expect investors to focus on the uptake of the same.
Meanwhile, Zolgensma has been granted PRIME (PRIority MEdicines) designation in Europe and being reviewed under Accelerated Assessment Procedure.
Novartis’ stock has gained 2% in the year so far compared with the industry's 0.8% growth.
Approval of new drugs and label expansion of existing drugs bode well for the company, as it looks to streamline its business. Last year was a transformative one for Novartis, as it restructured its business to become a core drug-focused company, powered by data and digital technologies.
The company acquired U.S.-based clinical-stage gene-therapy company, AveXis, Inc, in 2018. Novartis also acquired Endocyte to expand expertise in radiopharmaceuticals. We expect more acquisitions in the coming months, as the company looks to further restructure the business. The separation of the Alcon business is a step in the right direction, as the business was not performing as per management’s expectations.
Zacks Rank & Stocks to Consider
Novartis currently carries a Zacks Rank #4 (Sell).
Bristol-Myers’ earnings per share estimates have increased from $4.78 to $5.03 for 2020 in the past 60 days.
Roche’s earnings per share estimates have increased from $2.35 to $2.40 for 2019 in the past 60 days.
More Stock News: This Is Bigger than the iPhone!
It could become the mother of all technological revolutions. Apple sold a mere 1 billion iPhones in 10 years but a new breakthrough is expected to generate more than 27 billion devices in just 3 years, creating a $1.7 trillion market.
Zacks has just released a Special Report that spotlights this fast-emerging phenomenon and 6 tickers for taking advantage of it. If you don't buy now, you may kick yourself in 2020.
Image: Bigstock
Novartis Gets FDA Nod for Breast Cancer Drug & Gene Therapy
Novartis AG (NVS - Free Report) announced that the FDA has approved Piqray (alpelisib, formerly BYL719) for breast cancer.
The drug has been approved in combination with AstraZeneca’s (AZN - Free Report) Faslodex for the treatment of postmenopausal women, and men with hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-), PIK3CA-mutated, advanced or metastatic breast cancer, as detected by an FDA-approved test following progression on or after an endocrine-based regimen.
The approval was based on results of the phase III study, SOLAR-1, which showed Piqray in combination with Faslodex nearly doubled median progression-free survival (PFS) compared to Faslodex alone in HR+/HER2- advanced breast cancer patients with a PIK3CA mutation.
The market potential for Piqray is good as PIK3CA is the most commonly mutated gene in HR+/HER2- breast cancer and approximately 40% of patients living with HR+/HER2- breast cancer have this mutation. Per Novartis, the drug is the first ever treatment developed specifically for HR+/HER2- advanced breast cancer with a PIK3CA mutation.
The approval of Piqray will further strengthen Novartis’ strong oncology portfolio, including drugs like Afinitor, Exjade, Jakavi, Zykadia, Tasigna, Luthathera, Promacta and Jadenu.
In addition, the FDA also approved Zolgensma, the first and only gene therapy for pediatric patients with spinal muscular atrophy (SMA), a rare genetic disorder. The therapy has been approved for pediatric patients less than 2 years of age. Zolgensma addresses the genetic root cause of SMA by providing a functional copy of the human SMN gene to halt disease progression through sustained SMN protein expression with a single, one-time intravenous (IV) infusion. The approval of the drug was based on data from the ongoing phase III STR1VE study.
The therapy has been priced at $2.125 million, one of the most expensive treatments. Given the high cost of the treatment, we expect investors to focus on the uptake of the same.
Meanwhile, Zolgensma has been granted PRIME (PRIority MEdicines) designation in Europe and being reviewed under Accelerated Assessment Procedure.
Novartis’ stock has gained 2% in the year so far compared with the industry's 0.8% growth.
Approval of new drugs and label expansion of existing drugs bode well for the company, as it looks to streamline its business. Last year was a transformative one for Novartis, as it restructured its business to become a core drug-focused company, powered by data and digital technologies.
The company acquired U.S.-based clinical-stage gene-therapy company, AveXis, Inc, in 2018. Novartis also acquired Endocyte to expand expertise in radiopharmaceuticals. We expect more acquisitions in the coming months, as the company looks to further restructure the business. The separation of the Alcon business is a step in the right direction, as the business was not performing as per management’s expectations.
Zacks Rank & Stocks to Consider
Novartis currently carries a Zacks Rank #4 (Sell).
Some better-ranked stocks in the same space are Bristol-Myers Squibb Co. (BMY - Free Report) and Roche (RHHBY - Free Report) . While Bristol-Myers sports a Zacks Rank #1 (Strong Buy), Roche carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Bristol-Myers’ earnings per share estimates have increased from $4.78 to $5.03 for 2020 in the past 60 days.
Roche’s earnings per share estimates have increased from $2.35 to $2.40 for 2019 in the past 60 days.
More Stock News: This Is Bigger than the iPhone!
It could become the mother of all technological revolutions. Apple sold a mere 1 billion iPhones in 10 years but a new breakthrough is expected to generate more than 27 billion devices in just 3 years, creating a $1.7 trillion market.
Zacks has just released a Special Report that spotlights this fast-emerging phenomenon and 6 tickers for taking advantage of it. If you don't buy now, you may kick yourself in 2020.
Click here for the 6 trades >>