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The FDA, which gave its nod to 22 treatments last year, has given its approval to 5 drugs so far in 2017. This includes Synergy’s Trulance (treatment of chronic idiopathic constipation (CIC) in adults), Amgen’s (AMGN - Free Report) Parsabiv (treatment of secondary hyperparathyroidism in adult patients with chronic kidney disease undergoing dialysis), Marathon’s Emflaza (Duchenne muscular dystrophy), Valeant’s Siliq (moderate-to-severe plaque psoriasis) and Lexicon’s Xermelo (treatment of carcinoid syndrome diarrhea).
Here is a look at a few important regulatory events scheduled for the month of March.
First up is drugmaker Merck & Co., Inc. (MRK - Free Report) which is awaiting two FDA decisions this month for its anti-PD-1 therapy, Keytruda. While a decision regarding the approval status of Keytruda for the treatment of previously treated patients with advanced microsatellite instability-high cancer is expected by Mar 8, a decision regarding the treatment of patients with refractory classical Hodgkin lymphoma (cHL) or for patients with cHL who have relapsed after three or more prior lines of therapy should be out by mid-March. Keytruda, one of Merck’s new products, is already approved for different types of cancer and brought in sales of $1.4 billion in 2016. Merck is working on expanding the label of the product. Merck, a Zacks Rank #3 (Hold) stock, has outperformed the Zacks-categorized Large Cap Pharmaceuticals industry over the last one year with the company’s shares gaining 26.5% compared to the industry gain of 6.6%.
Roche Holding AG (RHHBY - Free Report) will also be getting a response from the FDA for Ocrevus (ocrelizumab) -- the FDA action date for this candidate was extended by three months to Mar 28, 2017 in Dec 2016. The extension resulted from additional data submitted by Roche related to the commercial manufacturing process for the drug. Roche is looking to get the drug approved for relapsing forms of multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS). Roche, a Zacks Rank #5 (Strong Sell) stock, has underperformed the Zacks-categorized Large Cap Pharmaceuticals industry over the last one year with the company’s shares gaining 3.1% compared to the industry gain of 6.6%.
Regeneron Pharmaceuticals, Inc. (REGN - Free Report) and partner Sanofi (SNY - Free Report) will get to know about the approval status of their eczema treatment, Dupixent, by Mar 29, 2017. Dupixent, which has blockbuster potential, is being investigated for other indications as well including asthma and nasal polyps. A confirmatory phase III study for the asthma indication is ongoing and positive results would allow the company to file for FDA approval in the fourth quarter of 2017. While both Sanofi and Regeneron are Zacks Rank #3 stocks, you can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Sanofi has performed better than the Zacks-categorized Large Cap Pharmaceuticals industry over the last one year with the company’s shares gaining 10.8% during this period. Regeneron, on the other hand, has underperformed the Zacks-categorized Medical-Biomedical/Genetics industry with shares declining 7.2% over the last one year compared to the industry decline of 2.5%.
Science-driven biopharmaceutical company Radius Health, Inc. (RDUS - Free Report) is also awaiting a response from the FDA for its regulatory application for abaloparatide-SC for the treatment of postmenopausal women with osteoporosis. A response from the agency should be out by Mar 30. Radius is currently working on putting a commercial structure in place so that the product can be launched immediately after gaining approval. The Zacks Rank #3 stock has outperformed the Zacks-categorized Medical-Drugs industry over the past one year with shares gaining 24.8% compared to the industry gain of 4.9%.
With the drug development process being lengthy and time-consuming and requiring the utilization of a lot of funds and resources, key pipeline events including data readouts and regulatory updates are of paramount importance -- companies which hit the bull’s eye become overnight success stories with shares even doubling or tripling on positive news while negative outcomes have an equally strong effect on the shares and failure may very well spell doom for these companies.
Zacks' Top 10 Stocks for 2017
In addition to the stocks discussed above, would you like to know about our 10 finest buy-and-hold tickers for the entirety of 2017?
Who wouldn't? Last year's market-beating Top 10 portfolio produced 5 double-digit winners. For example, oil and natural gas giant Pioneer Natural Resources and First Republic Bank racked up stellar gains of +44.9% and +44.3% respectively. Now a brand-new list for 2017 has been hand-picked from 4,400 companies covered by the Zacks Rank. See the 2017 Top 10 right now>>
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5 FDA Decisions to Watch Out for in Mar 2017
The FDA, which gave its nod to 22 treatments last year, has given its approval to 5 drugs so far in 2017. This includes Synergy’s Trulance (treatment of chronic idiopathic constipation (CIC) in adults), Amgen’s (AMGN - Free Report) Parsabiv (treatment of secondary hyperparathyroidism in adult patients with chronic kidney disease undergoing dialysis), Marathon’s Emflaza (Duchenne muscular dystrophy), Valeant’s Siliq (moderate-to-severe plaque psoriasis) and Lexicon’s Xermelo (treatment of carcinoid syndrome diarrhea).
Here is a look at a few important regulatory events scheduled for the month of March.
First up is drugmaker Merck & Co., Inc. (MRK - Free Report) which is awaiting two FDA decisions this month for its anti-PD-1 therapy, Keytruda. While a decision regarding the approval status of Keytruda for the treatment of previously treated patients with advanced microsatellite instability-high cancer is expected by Mar 8, a decision regarding the treatment of patients with refractory classical Hodgkin lymphoma (cHL) or for patients with cHL who have relapsed after three or more prior lines of therapy should be out by mid-March. Keytruda, one of Merck’s new products, is already approved for different types of cancer and brought in sales of $1.4 billion in 2016. Merck is working on expanding the label of the product. Merck, a Zacks Rank #3 (Hold) stock, has outperformed the Zacks-categorized Large Cap Pharmaceuticals industry over the last one year with the company’s shares gaining 26.5% compared to the industry gain of 6.6%.
Roche Holding AG (RHHBY - Free Report) will also be getting a response from the FDA for Ocrevus (ocrelizumab) -- the FDA action date for this candidate was extended by three months to Mar 28, 2017 in Dec 2016. The extension resulted from additional data submitted by Roche related to the commercial manufacturing process for the drug. Roche is looking to get the drug approved for relapsing forms of multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS). Roche, a Zacks Rank #5 (Strong Sell) stock, has underperformed the Zacks-categorized Large Cap Pharmaceuticals industry over the last one year with the company’s shares gaining 3.1% compared to the industry gain of 6.6%.
Regeneron Pharmaceuticals, Inc. (REGN - Free Report) and partner Sanofi (SNY - Free Report) will get to know about the approval status of their eczema treatment, Dupixent, by Mar 29, 2017. Dupixent, which has blockbuster potential, is being investigated for other indications as well including asthma and nasal polyps. A confirmatory phase III study for the asthma indication is ongoing and positive results would allow the company to file for FDA approval in the fourth quarter of 2017. While both Sanofi and Regeneron are Zacks Rank #3 stocks, you can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Sanofi has performed better than the Zacks-categorized Large Cap Pharmaceuticals industry over the last one year with the company’s shares gaining 10.8% during this period. Regeneron, on the other hand, has underperformed the Zacks-categorized Medical-Biomedical/Genetics industry with shares declining 7.2% over the last one year compared to the industry decline of 2.5%.
Science-driven biopharmaceutical company Radius Health, Inc. (RDUS - Free Report) is also awaiting a response from the FDA for its regulatory application for abaloparatide-SC for the treatment of postmenopausal women with osteoporosis. A response from the agency should be out by Mar 30. Radius is currently working on putting a commercial structure in place so that the product can be launched immediately after gaining approval. The Zacks Rank #3 stock has outperformed the Zacks-categorized Medical-Drugs industry over the past one year with shares gaining 24.8% compared to the industry gain of 4.9%.
With the drug development process being lengthy and time-consuming and requiring the utilization of a lot of funds and resources, key pipeline events including data readouts and regulatory updates are of paramount importance -- companies which hit the bull’s eye become overnight success stories with shares even doubling or tripling on positive news while negative outcomes have an equally strong effect on the shares and failure may very well spell doom for these companies.
Zacks' Top 10 Stocks for 2017
In addition to the stocks discussed above, would you like to know about our 10 finest buy-and-hold tickers for the entirety of 2017?
Who wouldn't? Last year's market-beating Top 10 portfolio produced 5 double-digit winners. For example, oil and natural gas giant Pioneer Natural Resources and First Republic Bank racked up stellar gains of +44.9% and +44.3% respectively. Now a brand-new list for 2017 has been hand-picked from 4,400 companies covered by the Zacks Rank. See the 2017 Top 10 right now>>