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Roche's (RHHBY) Esbriet sNDA Gets Priority Review From FDA
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Genentech, a wholly owned subsidiary of Roche Holding AG (RHHBY - Free Report) , announced that the FDA has accepted the supplemental new drug application (sNDA) for Esbriet (pirfenidone) for the treatment of unclassifiable interstitial lung disease (“UILD”), a rare and debilitating disease.
With the FDA granting a priority review to the sNDA, a decision from the regulatory body is expected by May 2021.
The sNDA was based on data from a pivotal, 24-week phase II study, which was the first randomized controlled study to exclusively enroll patients with UILD. Notably, interstitial lung disease, or ILD, broadly describes a diverse group of more than 200 types of rare pulmonary diseases.
Shares of Roche have increased 6.5% in the past year compared with the industry’s growth of 6.1%.
In March 2020, the FDA granted Breakthrough Therapy designation to Esbriet for treating UILD. The designation was based on data from a phase II study, which assessed the efficacy and safety of Esbriet in UILD. Esbriet also enjoys an Orphan Drug Designation for the given indication.
We remind investors that Esbriet is an oral medicine approved for the treatment of idiopathic pulmonary fibrosis in the United States as well as several other countries in the world.
A potential approval of Esbriet for the treatment of UILD will boost sales of the drug and can also serve an area of significant unmet medical need.
We note that Roche is making efforts to expand and diversify its immunology portfolio. Apart from Esbriet, the company’s immunology portfolio currently comprises drugs like Actemra for rheumatoid arthritis, Xolair, which is co-marketed with Novartis (NVS - Free Report) for asthma and Pulmozyme for cystic fibrosis, among others. Actemra has proven to be a strong growth driver for the company.
The company’s portfolio also includes Ocrevus for the treatment of two forms of multiple sclerosis (“MS”) — relapsing MS and primary progressive MS, along with Hemlibra for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and children with hemophilia A.
Zacks Rank & Stocks to Consider
Roche currently carries a Zacks Rank #3 (Hold). Better-ranked stocks in the drug/biotech sector include Alexion Pharmaceuticals, Inc. and Seagen Inc. , both carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Alexion’s earnings estimates have been revised 0.8% upward for 2021 over the past 60 days. The stock has rallied 41.6% in the past year
Seagen’s loss per share estimates have narrowed 14.3% for 2021 over the past 60 days. The stock has surged 70.8% in the past year.
Biggest Tech Breakthrough in a Generation
Be among the early investors in the new type of device that experts say could impact society as much as the discovery of electricity. Current technology will soon be outdated and replaced by these new devices. In the process, it’s expected to create 22 million jobs and generate $12.3 trillion in activity.
A select few stocks could skyrocket the most as rollout accelerates for this new tech. Early investors could see gains similar to buying Microsoft in the 1990s. Zacks’ just-released special report reveals 8 stocks to watch. The report is only available for a limited time.
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Roche's (RHHBY) Esbriet sNDA Gets Priority Review From FDA
Genentech, a wholly owned subsidiary of Roche Holding AG (RHHBY - Free Report) , announced that the FDA has accepted the supplemental new drug application (sNDA) for Esbriet (pirfenidone) for the treatment of unclassifiable interstitial lung disease (“UILD”), a rare and debilitating disease.
With the FDA granting a priority review to the sNDA, a decision from the regulatory body is expected by May 2021.
The sNDA was based on data from a pivotal, 24-week phase II study, which was the first randomized controlled study to exclusively enroll patients with UILD. Notably, interstitial lung disease, or ILD, broadly describes a diverse group of more than 200 types of rare pulmonary diseases.
Shares of Roche have increased 6.5% in the past year compared with the industry’s growth of 6.1%.
In March 2020, the FDA granted Breakthrough Therapy designation to Esbriet for treating UILD. The designation was based on data from a phase II study, which assessed the efficacy and safety of Esbriet in UILD. Esbriet also enjoys an Orphan Drug Designation for the given indication.
We remind investors that Esbriet is an oral medicine approved for the treatment of idiopathic pulmonary fibrosis in the United States as well as several other countries in the world.
A potential approval of Esbriet for the treatment of UILD will boost sales of the drug and can also serve an area of significant unmet medical need.
We note that Roche is making efforts to expand and diversify its immunology portfolio. Apart from Esbriet, the company’s immunology portfolio currently comprises drugs like Actemra for rheumatoid arthritis, Xolair, which is co-marketed with Novartis (NVS - Free Report) for asthma and Pulmozyme for cystic fibrosis, among others. Actemra has proven to be a strong growth driver for the company.
The company’s portfolio also includes Ocrevus for the treatment of two forms of multiple sclerosis (“MS”) — relapsing MS and primary progressive MS, along with Hemlibra for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and children with hemophilia A.
Zacks Rank & Stocks to Consider
Roche currently carries a Zacks Rank #3 (Hold). Better-ranked stocks in the drug/biotech sector include Alexion Pharmaceuticals, Inc. and Seagen Inc. , both carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Alexion’s earnings estimates have been revised 0.8% upward for 2021 over the past 60 days. The stock has rallied 41.6% in the past year
Seagen’s loss per share estimates have narrowed 14.3% for 2021 over the past 60 days. The stock has surged 70.8% in the past year.
Biggest Tech Breakthrough in a Generation
Be among the early investors in the new type of device that experts say could impact society as much as the discovery of electricity. Current technology will soon be outdated and replaced by these new devices. In the process, it’s expected to create 22 million jobs and generate $12.3 trillion in activity.
A select few stocks could skyrocket the most as rollout accelerates for this new tech. Early investors could see gains similar to buying Microsoft in the 1990s. Zacks’ just-released special report reveals 8 stocks to watch. The report is only available for a limited time.
See 8 breakthrough stocks now>>