Synergy Pharmaceuticals Inc (NASDAQ:SGYP)
Synergy Pharmaceuticals is having a rough day in the market today. While the declines are for good reason, I have to say, I'm not concerned. The reason the stock is declining is because of enrollment blues for two phase 3 clinical trials. However, we also received good news with regard to a current New Drug Application with the FDA. Today, we'll talk about the news, how the market reacted, and what I'm expecting to see from SGYP moving forward.
SGYP Takes A Dive On Enrollment Blues
As mentioned above, Synergy Pharmaceuticals is having a rough trading session today. Unfortunately, the company announced that patient enrollment for two ongoing phase 3 clinical trials has been running at a slower-than-expected pace. As a result, the company will continue enrollment for trials associated with plecanatide as a treatment for IBS-C.
The company explained that one of the big issues with enrollment was that they have noticed an increase in the number of patients that are not meeting randomization criteria. This is being noticed in the screening period prior to treatment. Nonetheless, enrollment will continue. In a statement, Dr. Gary Jacob, CEO at SGYP, had the following to offer:
“Our first priority is to ensure high quality trials that reflect our rigorous standards and expectations... To that end, we are updating our timing for top-line data in both trials to the fourth quarter of this year and intend to file the plecanatide NDA in IBS-C in the first quarter of 2017. We remain confident that plecanatide will continue to deliver outstanding clinical results consistent with previous trials, ultimately providing an important treatment option for patients suffering from IBS-C.”
NDA News
In other news with regard to SGYP, the company has announced a key milestone. Today, the company announced that it has reached the FDA mid-cycle review milestone for the plecanatide New Drug Application. The application surrounds plecanatide's ability to treat chronic idiopathic constipation. In a statement, Dr. Jacob had the following to offer:
“We are pleased with the progress and ongoing dialogue with the FDA... We remain optimistic about the potential approval of plecanatide in CIC by the PDUFA date of January 29, 2017. I am also very pleased with the progress our commercial, medical affairs and supply chain teams have made in recent months as we anticipate bringing this important new treatment option to CIC patients and their caregivers early next year.”
How The Market Reacted To The News
One of the first things that we learn as investors is to watch the news. After all, the news moves the market. In this particular case, while the news surrounding the NDA was positive, Synergy Pharmaceuticals investors seem to be focusing on the delayed results from the CIC trials. As a result, we're seeing declines in the value of the stock today. Currently (1:56), SGYP is trading at $3.54 per share after a loss of $0.28 per share, or 7.44%, thus far today.
What We Can Expect To See Moving Forward
As you could likely gather from the title of this article, I have a relatively bullish opinion of what we can expect to see from SGYP. While it is unfortunate that enrollment is slow for the two pivotal plecanatide phase 3 trials, I have faith that the company will be filling enrollment and producing positive results. After watching previous trials in IBS-C, the results really speak for themselves.
As far as the CIC NDA goes, I have incredibly high hopes there as well. After paying close attention to the trials Synergy Pharmaceuticals conducted surrounding the indication, it's clear that the treatment is significant for the CIC community. All in all, I'm expecting to see gains from SGYP moving forward.