Yahoo Finance Key FDA Events to Watch Out for in Q1
Key pipeline events such as data readouts and regulatory updates are highly awaited in the Medical sector. However, drug development process is often lengthy and time consuming, and involves a lot of funds and resources. It could take a candidate anything between 10–12 years to be successfully developed and reach the market.
Let’s take a look at two important regulatory events scheduled for the first quarter of 2017.
Plecanatide (chronic idiopathic constipation): Synergy Pharmaceuticals, Inc.’s SGYP first uroguanylin analog, plecanatide, is currently under FDA review for the treatment of patients with chronic idiopathic constipation. A response from the FDA is expected on Jan 29. An approval of the product will allow the company to launch its first product in the market. Note that Synergy is also evaluating plecanatide in a phase III study for the treatment of irritable bowel syndrome with constipation (IBS-C). The company plans to file a regulatory application for the candidate in the IBS-C indication in the first quarter of 2017.
Synergy’s share price movement in the past one year shows that the company has outperformed the Medical Drugs industry, with the stock increasing 67%, while the industry registered a decline of 8.8%.
Dupixent (inadequately controlled moderate-to-severe atopic dermatitis): Regeneron Pharmaceuticals, Inc. REGN and Sanofi’s SNY Dupixent (dupilumab) is currently under FDA review with a response expected on Mar 29. The companies are looking to get Dupixent approved for the treatment of adult patients with inadequately controlled moderate-to-severe atopic dermatitis, a chronic inflammatory skin disease. We note that Dupixent enjoys Breakthrough Therapy status in the U.S. for the treatment of adults with moderate-to-severe atopic dermatitis who are not adequately controlled with topical prescription therapies or for whom these treatments are not appropriate. This designation should expedite the development and review process of the candidate.
A look at Regeneron’s price movement in the past one year shows that the company has underperformed the Medical-Biomedical/Genetics industry. Specifically, the stock declined 11.3%, compared to the industry’s 20.5% fall.
Shares of Sanofi, on the other hand, have outperformed the Large Cap Pharma industry in the past one year. The stock increased 7.4% during this period, while the industry rose 1.5%.
Key Picks in the Sector
Investors looking for a favorably placed stock in the health care sector can consider Sucampo Pharmaceuticals, Inc. SCMP, which sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Sucmapo’s earnings estimates were stable at $1.22 for 2016 but have increased from $1.30 to $1.74 for 2017 over the last 60 days. The company posted a positive earnings surprise in all of the four trailing quarters with an average beat of 35.5%.
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