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Two Key FDA Decisions to Watch Out for in January 2017
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The drug development process is often lengthy and time-consuming and requires the utilization of a lot of funds and resources. It may well take a drug anything between 10-12 years to be successfully developed and reach the market. In such a scenario, 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. Last year, the FDA had approved 22 drugs including Spinraza (spinal muscular atrophy), Rubraca (ovarian cancer), Exondys 51 (Duchenne muscular dystrophy), Epclusa (all six major forms of hepatitis C virus), and Zinbryta (multiple sclerosis) among others.
Here is a look at a couple of important regulatory events scheduled for this month.
Wilmington, DE-based Incyte Corporation (INCY - Free Report) and large cap pharma partner Eli Lilly and Company (LLY - Free Report) could well receive FDA approval for their investigational rheumatoid arthritis (RA) treatment, baricitinib, this month. The NDA for the oral once-daily drug was submitted a year back in January. Incyte, which is often considered an attractive takeover target, has performed better than the Zacks-categorized Medical-Biomedical/Genetics industry over the past one year with the company declining 3% compared to the industry decline of 24.7%. Approval for baricitinib, a JAK1 and JAK2 inhibitor, would be a major boost for the company which is eligible to earn regulatory and commercial milestones as well as royalties on global net sales. Although the RA market is pretty crowded, there still remains unmet need for new safe and effective treatment options.
New York-based Synergy Pharmaceuticals Inc. , which is focused on the development and commercialization of novel gastrointestinal (GI) therapies, has an important regulatory event coming up towards the end of this month with the FDA expected to decide on the approval status of one of the company’s lead pipeline candidates – plecanatide.
The company is looking to get the product approved for the treatment of chronic idiopathic constipation (CIC) with a response expected by Jan 29, 2017. FDA approval would be a transforming event for the company which currently has no approved products in its portfolio. Synergy, a Zacks Rank #3 (Hold) stock, had a good run in 2016 with the company gaining 13.4% compared to a 23% decline for the Zacks-categorized Medical-Drugs industry. The company, in fact, ended 2016 on a positive note with impressive top-line data from a couple of pivotal studies on plecanatide in adult patients with irritable bowel syndrome with constipation (IBS-C). Depending on the FDA’s decision regarding the CIC indication, Synergy will seek approval for the IBS-C indication in the first quarter of 2017. The market opportunity is huge considering about 45 million adults in the U.S. suffer from CIC/IBS-C with the market expected to grow at double digit rates on the back of increased treatment options, market education, an aging population and awareness of gut health.
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Two Key FDA Decisions to Watch Out for in January 2017
The drug development process is often lengthy and time-consuming and requires the utilization of a lot of funds and resources. It may well take a drug anything between 10-12 years to be successfully developed and reach the market. In such a scenario, 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. Last year, the FDA had approved 22 drugs including Spinraza (spinal muscular atrophy), Rubraca (ovarian cancer), Exondys 51 (Duchenne muscular dystrophy), Epclusa (all six major forms of hepatitis C virus), and Zinbryta (multiple sclerosis) among others.
Here is a look at a couple of important regulatory events scheduled for this month.
Wilmington, DE-based Incyte Corporation (INCY - Free Report) and large cap pharma partner Eli Lilly and Company (LLY - Free Report) could well receive FDA approval for their investigational rheumatoid arthritis (RA) treatment, baricitinib, this month. The NDA for the oral once-daily drug was submitted a year back in January. Incyte, which is often considered an attractive takeover target, has performed better than the Zacks-categorized Medical-Biomedical/Genetics industry over the past one year with the company declining 3% compared to the industry decline of 24.7%. Approval for baricitinib, a JAK1 and JAK2 inhibitor, would be a major boost for the company which is eligible to earn regulatory and commercial milestones as well as royalties on global net sales. Although the RA market is pretty crowded, there still remains unmet need for new safe and effective treatment options.
Incyte is a Zacks Rank #2 (Buy) stock. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
New York-based Synergy Pharmaceuticals Inc. , which is focused on the development and commercialization of novel gastrointestinal (GI) therapies, has an important regulatory event coming up towards the end of this month with the FDA expected to decide on the approval status of one of the company’s lead pipeline candidates – plecanatide.
The company is looking to get the product approved for the treatment of chronic idiopathic constipation (CIC) with a response expected by Jan 29, 2017. FDA approval would be a transforming event for the company which currently has no approved products in its portfolio. Synergy, a Zacks Rank #3 (Hold) stock, had a good run in 2016 with the company gaining 13.4% compared to a 23% decline for the Zacks-categorized Medical-Drugs industry. The company, in fact, ended 2016 on a positive note with impressive top-line data from a couple of pivotal studies on plecanatide in adult patients with irritable bowel syndrome with constipation (IBS-C). Depending on the FDA’s decision regarding the CIC indication, Synergy will seek approval for the IBS-C indication in the first quarter of 2017. The market opportunity is huge considering about 45 million adults in the U.S. suffer from CIC/IBS-C with the market expected to grow at double digit rates on the back of increased treatment options, market education, an aging population and awareness of gut health.
Zacks' Top 10 Stocks for 2017
In addition to the stocks discussed above, would you like to know about our 10 finest tickers for the entirety of 2017?
Who wouldn't? These 10 are painstakingly hand-picked from 4,400 companies covered by the Zacks Rank. They are our primary picks to buy and hold. Be among the very first to see them >>