Synergy Pharmaceuticals Inc. (NASDAQ: SGYP) stumbled on Friday, and over the course of the week for that matter, despite a strong upward push in the broad markets. The company has been in an open discussion with the U.S. Food and Drug Administration (FDA) regarding the new drug application (NDA) for its chronic idiopathic constipation (CIC) treatment, as well as for its irritable bowel syndrome with constipation (IBS-C) program. However, the investor reaction was not as positive as the company would have hoped.
Specifically, the company announced that it has reached the FDA mid-cycle review milestone for the plecanatide NDA in CIC. Additionally, the company provided an update on its ongoing IBS-C program.
So far, management has been pleased with the progress and it remains optimistic about the potential approval of plecanatide in CIC by the Prescription Drug User Fee Act (PDUFA) date of January 29, 2017.
Previously, Synergy announced positive phase 3 data with plecanatide in two pivotal CIC clinical trials, and on January 29, 2016, the company submitted its first NDA for plecanatide in CIC. If approved, Synergy plans to launch plecanatide with the CIC indication in the first quarter of 2017.
In the update, Synergy decided to continue patient enrollment for its two ongoing Phase 3 clinical trials with plecanatide in IBS-C. The decision to continue enrollment comes after trial monitoring demonstrated a slower enrollment pace combined with an increase in the number of patients not meeting randomization criteria after the screening period prior to starting treatment.
Gary S. Jacob, chairman and CEO of Synergy Pharmaceuticals, commented:
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.
Excluding Friday’s move, Synergy has vastly underperformed the broad markets, with the stock down about 32% year to date. Over the past 52 weeks, the stock is down over 55%.
Shares of Synergy Pharmaceuticals closed trading down less than 6% at $3.61 on Friday, with a consensus analyst price target of $9.90 and a 52-week trading range of $2.50 to $9.76.