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The FDA, which approved 22 treatments last year, has given its approval to 12 drugs so far in 2017 including 7 in March. Key approvals this year include Roche’s (RHHBY - Free Report) multiple sclerosis treatment, Ocrevus, Regeneron (REGN - Free Report) and Sanofi’s eczema treatment, Dupixent, Tesaro’s PARP inhibitor, Zejula, and Amgen’s Parsabiv (treatment of secondary hyperparathyroidism in adult patients with chronic kidney disease undergoing dialysis) among others. Some of these drugs have blockbuster potential.
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. Here is a look at a few important regulatory events scheduled for the month of April.
BioMarin Pharmaceutical Inc. (BMRN - Free Report) , which holds a strong position in the rare disease market, has an important regulatory date coming up later this month with the FDA expected to decide on the approval status of Brineura. BioMarin is looking to get Brineura approved for the treatment of CLN2 disease, a form of Batten disease. The PDUFA date for Brineura was extended by the FDA in Sep 2016 by three months to Apr 27, 2017 following the submission of updated efficacy data cut from an ongoing extension study. There are no approved treatments for this rapidly progressing, fatal neurodegenerative disease -- BioMarin estimates the incidence of CLN2 disease in its commercial territories to be approximately 1,200 - 1,600 children.
Year-to-date (YTD) BioMarin, a Zacks Rank #3 (Hold) stock, has outperformed the Zacks-categorized Medical-Biomedical/Genetics industry with shares gaining 6% compared to the industry gain of almost 4%.
Takeda Pharmaceutical also has a FDA action date coming up this month with the agency expected to decide on the approval status of the company’s investigational oral ALK inhibitor, brigatinib. Brigatinib became a part of Takeda’s pipeline following the Feb 2017 acquisition of ARIAD. Brigatinib is under FDA review for ALK+ non-small cell lung cancer (NSCLC) with a response expected by Apr 29, 2017. Brigatinib has blockbuster potential.
Takeda has performed better than the Zacks categorized Medical-Drugs industry YTD with the company gaining 13.7% compared to the industry gain of 2.5%.
Swiss pharma giant, Roche is looking to expand the label of its first cancer immunotherapy Tecentriq for an additional type of advanced bladder cancer. Tecentriq, which gained FDA approval last year, is under review for the treatment (first-line as well as in patients whose disease has progressed at least 12 months after receiving chemotherapy before surgery (neoadjuvant) or after surgery (adjuvant)) of people with locally advanced or metastatic urothelial carcinoma (mUC) not eligible for cisplatin chemotherapy. The FDA is expected to respond by Apr 30.
Eli Lilly and Company (LLY - Free Report) and partner Incyte Corporation (INCY - Free Report) could also see one of their drugs gaining FDA approval this month. The companies are seeking FDA approval for Olumiant (baricitinib), a once-daily oral medication for the treatment of moderate to severe rheumatoid arthritis (RA). Olumiant gained approval in the EU in Feb 2017 making it the first JAK inhibitor to be approved to treat RA in the EU. However, Olumiant has been facing a delay in the U.S. with the PDUFA date being extended by the agency following the submission of additional data analyses by Lilly in response to the FDA's information requests. The FDA extended the action date by 3 months and a response could be out this month.
Both Lilly and Incyte are Zacks Rank #3 stocks. YTD, Lilly is up 14.4%, outperforming the Zacks-categorized Large Cap Pharmaceuticals industry during this period.
Incyte has outperformed the Zacks-categorized Medical-Biomedical/Genetics industry during so far in 2017 with the company’s shares gaining 33.3%.
More Stock News: 8 Companies Verge on Apple-Like Run
Did you miss Apple's 9X stock explosion after they launched their iPhone in 2007? Now 2017 looks to be a pivotal year to get in on another emerging technology expected to rock the market. Demand could soar from almost nothing to $42 billion by 2025. Reports suggest it could save 10 million lives per decade which could in turn save $200 billion in U.S. healthcare costs.
A bonus Zacks Special Report names this breakthrough and the 8 best stocks to exploit it. Like Apple in 2007, these companies are already strong and coiling for potential mega-gains. Click to see them right now >>
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4 FDA Decisions to Watch Out for in Apr 2017
The FDA, which approved 22 treatments last year, has given its approval to 12 drugs so far in 2017 including 7 in March. Key approvals this year include Roche’s (RHHBY - Free Report) multiple sclerosis treatment, Ocrevus, Regeneron (REGN - Free Report) and Sanofi’s eczema treatment, Dupixent, Tesaro’s PARP inhibitor, Zejula, and Amgen’s Parsabiv (treatment of secondary hyperparathyroidism in adult patients with chronic kidney disease undergoing dialysis) among others. Some of these drugs have blockbuster potential.
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. Here is a look at a few important regulatory events scheduled for the month of April.
BioMarin Pharmaceutical Inc. (BMRN - Free Report) , which holds a strong position in the rare disease market, has an important regulatory date coming up later this month with the FDA expected to decide on the approval status of Brineura. BioMarin is looking to get Brineura approved for the treatment of CLN2 disease, a form of Batten disease. The PDUFA date for Brineura was extended by the FDA in Sep 2016 by three months to Apr 27, 2017 following the submission of updated efficacy data cut from an ongoing extension study. There are no approved treatments for this rapidly progressing, fatal neurodegenerative disease -- BioMarin estimates the incidence of CLN2 disease in its commercial territories to be approximately 1,200 - 1,600 children.
Year-to-date (YTD) BioMarin, a Zacks Rank #3 (Hold) stock, has outperformed the Zacks-categorized Medical-Biomedical/Genetics industry with shares gaining 6% compared to the industry gain of almost 4%.
Takeda Pharmaceutical also has a FDA action date coming up this month with the agency expected to decide on the approval status of the company’s investigational oral ALK inhibitor, brigatinib. Brigatinib became a part of Takeda’s pipeline following the Feb 2017 acquisition of ARIAD. Brigatinib is under FDA review for ALK+ non-small cell lung cancer (NSCLC) with a response expected by Apr 29, 2017. Brigatinib has blockbuster potential.
Takeda has performed better than the Zacks categorized Medical-Drugs industry YTD with the company gaining 13.7% compared to the industry gain of 2.5%.
Swiss pharma giant, Roche is looking to expand the label of its first cancer immunotherapy Tecentriq for an additional type of advanced bladder cancer. Tecentriq, which gained FDA approval last year, is under review for the treatment (first-line as well as in patients whose disease has progressed at least 12 months after receiving chemotherapy before surgery (neoadjuvant) or after surgery (adjuvant)) of people with locally advanced or metastatic urothelial carcinoma (mUC) not eligible for cisplatin chemotherapy. The FDA is expected to respond by Apr 30.
Roche has outperformed the Zacks-categorized Large Cap Pharmaceuticals industry with the company’s shares gaining 12.3% compared to the industry gain of 6.1%. Roche is a Zacks Rank #2 (Buy) stock -- you can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Eli Lilly and Company (LLY - Free Report) and partner Incyte Corporation (INCY - Free Report) could also see one of their drugs gaining FDA approval this month. The companies are seeking FDA approval for Olumiant (baricitinib), a once-daily oral medication for the treatment of moderate to severe rheumatoid arthritis (RA). Olumiant gained approval in the EU in Feb 2017 making it the first JAK inhibitor to be approved to treat RA in the EU. However, Olumiant has been facing a delay in the U.S. with the PDUFA date being extended by the agency following the submission of additional data analyses by Lilly in response to the FDA's information requests. The FDA extended the action date by 3 months and a response could be out this month.
Both Lilly and Incyte are Zacks Rank #3 stocks. YTD, Lilly is up 14.4%, outperforming the Zacks-categorized Large Cap Pharmaceuticals industry during this period.
Incyte has outperformed the Zacks-categorized Medical-Biomedical/Genetics industry during so far in 2017 with the company’s shares gaining 33.3%.
More Stock News: 8 Companies Verge on Apple-Like Run
Did you miss Apple's 9X stock explosion after they launched their iPhone in 2007? Now 2017 looks to be a pivotal year to get in on another emerging technology expected to rock the market. Demand could soar from almost nothing to $42 billion by 2025. Reports suggest it could save 10 million lives per decade which could in turn save $200 billion in U.S. healthcare costs.
A bonus Zacks Special Report names this breakthrough and the 8 best stocks to exploit it. Like Apple in 2007, these companies are already strong and coiling for potential mega-gains. Click to see them right now >>