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Synergy Pharmaceuticals, Inc. (SGYP) Preparing to File New Drug Application for Leading Product Candidate

Synergy Pharmaceuticals, Inc. (NASDAQ: SGYP) is a biopharmaceutical company focused on the development of novel therapies to treat gastrointestinal diseases and disorders. The company’s product pipeline includes two drug candidates currently being studied in four unique indications. Synergy’s leading candidate, plecanatide, is in late-stage clinical trials for the treatment of chronic idiopathic constipation (CIC) and irritable bowel syndrome with constipation (IBS-C). Additionally, the company’s next-generation candidate, SP-333, has successfully completed a phase II study in patients with opioid-induced constipation (OIC) and is currently being studied for the treatment of ulcerative colitis (UC).

In recent weeks, Synergy has made noteworthy progress toward the eventual commercialization of plecanatide. Earlier this month, the company announced the initiation of its second phase III clinical trial evaluating the efficacy and safety of the drug candidate in treating IBS-C. Synergy also recently announced positive top-line data results from its first of two phase III trials evaluating the treatment in patients with CIC. According to a report by the National Institute of Health, CIC affects an estimated 14 percent of the global population, demonstrating the immense market potential of plecanatide. Moving forward, these figures could translate into an opportunity for Synergy to experience improved financial results.

“These results strengthen our belief that plecanatide has the potential to not only effectively treat constipation but with a durability and tolerability profile that is ideal for chronic use,” Dr. Gary S. Jacob, chairman and chief executive officer of Synergy, stated in a news release. “We look forward to the results of our second pivotal [CIC] trial in the coming weeks.”

In the first quarter of 2015, Synergy secured the necessary capital to move forward in developing its promising product pipeline. Through a sale of common stock, the company added $5.4 million in net cash to its existing resources. As of March 31, 2015, Synergy’s cash and cash equivalents amounted to approximately $178.6 million, which will allow the company to continue vital clinical testing in the months to come.

“[This] is a pivotal year for Synergy and I am confident we are well-positioned to achieve our clinical objectives,” continued Jacob. “[We] will remain focused on advancing these programs, as well as filing our first NDA (new drug application) with plecanatide for CIC by year-end.”

By providing an effective treatment option for CIC, the company will be able to address an underserved market within the pharmaceutical industry. For prospective investors, Synergy’s rapid approach toward the commercialization of its leading drug candidate could foreshadow an opportunity for favorable returns in the months to come.

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