Why Synergy Pharmaceuticals Is Jumping 10% Today
IMAGE SOURCE: GETTY IMAGES.
What happened
After announcingpositive results in phase 3 trials evaluatingplecanatide for the treatment of irritable bowel syndrome with constipation (IBS-C), shares inSynergy Pharmaceuticals(NASDAQ: SGYP)rallied 10% this morning.
So what
Plecanatide is already under review by the FDA for approval in treating patients with chronic idiopathic constipation (CIC). That review is being based upon previously reported phase 3 successes that include a relativelylow incidence rate of severe diarrhea when compared to other treatment options.
Today, the company rolled out final phase 3 results showing that plecanatide may also address IBS-C, a condition that affects millions of people.
Preliminary overall response ratesin the 3 mg and 6 mg plecanatide arms and placebo arm were 30.2%, 29.5%, and 17.8%, respectively, with a p-value of <0.001.< p=""/>
Unsurprisingly, the most common adverse event was diarrhea, which occurred in 5.4% of patients in 3 mg and 4.3% of patients in 6 mg dose groups versus 0.6% of patients in the placebo arm of the study.
Now what
A FDA decision on plecanatide in CIC is anticipated on Jan. 29. Management expects to file a supplemental approval application for plecanatide's use in IBS-C in the first quarter.
If approved, plecanatide will face off againstIronwood Pharmaceuticals (NASDAQ: IRWD) and Allergan's(NYSE: AGN) Linzess. Linzess' U.S.net sales increased 34% year over year to $150.5 million in Q2 2016, andU.S.net sales increased 40% year over year to $164 million in Q3 2016.
10 stocks we like better than Synergy Pharmaceuticals When investing geniuses David and Tom Gardner have a stock tip, it can pay to listen. After all, the newsletter they have run for over a decade, Motley Fool Stock Advisor, has tripled the market.*
David and Tom just revealed what they believe are the 10 best stocks for investors to buy right now...and Synergy Pharmaceuticals wasn't one of them! That's right -- they think these 10 stocks are even better buys.
Click here to learn about these picks!
*Stock Advisor returns as of Nov. 7, 2016.
Todd Campbell has no position in any stocks mentioned.Todd owns E.B. Capital Markets, LLC. E.B. Capital's clients may have positions in the companies mentioned.Like this article? Follow him onTwitter where he goes by the handle@ebcapitalto see more articles like this.
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.