What: Shares of Synergy Pharmaceuticals (NASDAQ: SGYP) climbed by nearly 19% today on tremendous volume after the company reported that its lead experimental drug, plecanatide, met its primary endpoint in a second late-stage study as a treatment for chronic constipation with no known cause. Per the press release, plecanatide proved to be an effective and safe treatment for chronic constipation at both the 3 mg and 6 mg doses, compared to patients receiving a placebo. Last June, the company reported that the drug produced highly similar results in its first late-stage trial.
So what: Plecanatide could be Synergy's first approved product, transforming the clinical-stage biopharma into a commercial operation. Even more importantly, though, plecanatide is expected to see peak sales in excess of $800 million by 2023, if approved. That's a big deal for a company with market cap of less than $1 billion.
Now what: Synergy plans on filing a new drug application for plecanatide with the Food and Drug Administration in the first-quarter of 2016. Given the drug's reported consistency across two large, late-stage studies, I think there's a better than average chance that plecanatide will be on the market by the third or fourth quarter of next year; unless of course there are some hidden surprises that haven't been disclosed as of yet. With the company expected to release the details of the two studies at a couple of upcoming conferences, investors should definitely keep an eye peeled for these events.
