Synergy Pharmaceuticals Inc (NASDAQ: SGYP) is having an incredibly strong day in the market today, and for good reason. In a press release issued early this morning, the company updated investors with regard to a new FDA approval. Today, we’ll talk about the approval, what we’re seeing from the stock, and what we’ll be watching for with regard to SGYP ahead.
SGYP Announces FDA Approval
As mentioned above, Synergy Pharmaceuticals is having a great start to the trading session in the pre-market hours this morning, and for good reason. The company announced that the United States Food and Drug Administration has approved TRULANCE (plecanatide) 3mg tablets for once-daily use as a treatment for irritable bowel syndrome with constipation in adults.
This is the second approval that SGYP has announced surrounding TRULANCE. In fact, the first indication that was approved was chronic idiopathic constipation, also known as CIC. Ultimately, investors are hoping that the new approval will improve sales numbers as the company now has a far wider audience to target under FDA market approval. In a statement, Troy Hamilton, Pharm.D., CEO at SGYP, had the following to offer:
The IBS-C approval is a pivotal milestone for Synergy, representing the second approved indication for TRULANCE in the past 12 months… This approval demonstrates our unwavering commitment to provide a safe and effective treatment options for those patients living with these chronic GI disorders.
The above statement was followed up by William D. Chey, M.D., Professor of Medicine, Director of the GI Physiology Laboratory, and Co-Director of the Michigan Bowel Control Program at the University of Michigan. Here’s what he had to offer:
Approximately 1 in 20 Americans are living with IBS-C, many of whom are not satisfied with currently available treatment options… With this second indication for TRULANCE, patients and physicians will have a much-needed, new treatment option with an established safety profile that can effectively address abdominal pain and constipation experienced by patients with IBS-C.
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