Synergy Pharma's Trulance Gets FDA Approval, CEO 'Truly Thrilled'
Javier Hasse
The U.S. Food and Drug Administration said it approved Synergy Pharmaceuticals Inc's (NASDAQ: SGYP) plecanatide, branded as Trulance, for the treatment of chronic idiopathic constipation (CIC). This approval marks the company’s first.
Trulance is a one-tablet-a-day drug used to treat a form of gastrointestinal disorder that make patients have difficult and infrequent bowel movements. The drug is expected to generate peak sales of $348.8 million by 2021, Thomson Reuters has estimated.
Benzinga reached out to Synergy Pharma’s CEO, Gary Jacob, who provided this statement:
“We are truly thrilled with this approval because it provides an additional, much-needed, new treatment option to help adults with chronic idiopathic constipation and healthcare providers manage this condition.”
Synergy said it has plans to file a supplemental New Drug Application (NDA) for Trulance over the course of the current quarter seeking approval for the treatment of irritable bowel syndrome with constipation (IBS-C).
The stock initially fell over a $1 per share in the after-hours session and traded recently at $6.35, down about $0.06 from the close.
Javier Hasse
The U.S. Food and Drug Administration said it approved Synergy Pharmaceuticals Inc's (NASDAQ: SGYP) plecanatide, branded as Trulance, for the treatment of chronic idiopathic constipation (CIC). This approval marks the company’s first.
Trulance is a one-tablet-a-day drug used to treat a form of gastrointestinal disorder that make patients have difficult and infrequent bowel movements. The drug is expected to generate peak sales of $348.8 million by 2021, Thomson Reuters has estimated.
Benzinga reached out to Synergy Pharma’s CEO, Gary Jacob, who provided this statement:
“We are truly thrilled with this approval because it provides an additional, much-needed, new treatment option to help adults with chronic idiopathic constipation and healthcare providers manage this condition.”
Synergy said it has plans to file a supplemental New Drug Application (NDA) for Trulance over the course of the current quarter seeking approval for the treatment of irritable bowel syndrome with constipation (IBS-C).
The stock initially fell over a $1 per share in the after-hours session and traded recently at $6.35, down about $0.06 from the close.