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.
George Budwell has no position in any stocks mentioned. The Motley Fool has no position in any of the stocks mentioned. Try any of our Foolish newsletter services free for 30 days. We Fools may not all hold the same opinions, but we all believe that considering a diverse range of insights makes us better investors. The Motley Fool has a disclosure policy.