NEW YORK, NY / ACCESSWIRE / December 18, 2018 / Shares of Achillion Pharmaceuticals were in the red on Monday as traders waited for interim clinical-trial data from the company. Share reversed slightly in after-hours trading. Synergy Pharmaceuticals saw its shares explode on news from Cipher Pharmaceuticals Inc. announcing that its New Drug Submission for plecanatide for irritable bowel syndrome with constipation ("IBS-C") has been accepted by Health Canada. Cipher acquired the Canadian rights to develop, market, distribute and sell plecanatide from Synergy earlier this year.
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Achillion Pharmaceuticals, Inc.
Synergy Pharmaceuticals Inc.
Achillion Pharmaceuticals, Inc. shares closed down 22.83% on Monday with about 5.8 million shares traded. There was a slight rebound in after-hours trading of roughly 7% for the stock. While there was no news from the company, traders may have been gearing up for the biotech company's announcement of interim clinical-trial data from phase 2 clinical trials in C3 glomerulopathy (C3G) and paroxysmal nocturnal hemoglobinuria (PNH) and phase 1 data for Achillion's next-generation factor D inhibitors. The company then did report positive interim results for the Company’s Phase 2 trials of its first-generation oral factor D inhibitor, ACH-4471, as well as Phase 1 pharmacokinetics and potency data for its next-generation factor D inhibitors, ACH-5228 and ACH-5548. "These compelling findings underscore the momentum for Achillion and our factor D portfolio as we advance three oral small molecule compounds through clinical development. Our oral factor D inhibitors have the potential to treat patients suffering from alternative pathway mediated diseases,” said Joe Truitt, President and Chief Executive Officer of the company. He added, “In C3G, we have completed patient dosing in our 14-day biomarker/dose ranging study and we are currently enrolling patients in our 6 and 12-month PoC trials. We now have 18 clinical sites open globally and plan to open additional sites in 2019. We are also delighted that the FDA has recently agreed to allow adolescents in our trials as C3G is a disease with unmet medical needs that often begins in childhood. Our C3G plan is to enroll up to 20 patients in our 6 and 12-month trials and to present our data to the FDA at an End of Phase 2 meeting in Q4 2019.”
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Synergy Pharmaceuticals Inc. shares closed up 51.38% yesterday on about 57 million shares traded compared to an average trading volume of under 7 million shares. Wall Street was reacting to Cipher Pharmaceuticals Inc. announcing that its New Drug Submission for plecanatide for irritable bowel syndrome with constipation ("IBS-C") has been accepted by Health Canada. Cipher acquired the Canadian rights to develop, market, distribute and sell plecanatide (branded as TRULANCE® in the U.S.) from Synergy Pharmaceuticals Inc. in February of this year. "This is an important milestone for the commercialization of plecanatide, an innovative new product that provides a well-tolerated and effective treatment option for the many Canadians who suffer from chronic GI disorders," said Robert Tessarolo, President and CEO of Cipher. "We continue to execute on our growth strategy and launching plecanatide in late 2019, if approved, would be a significant step in building a diversified commercial portfolio."
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