18 April 2016 - Chiasma today provided an update regarding the previously announced complete response letter that was received after the close of the market on April 15, 2016 from the US FDA regarding the company’s new drug application for Mycapssa (octreotide acetate) capsules for the maintenance treatment of adult patients with acromegaly.
Upon completion of its review, the FDA advised Chiasma that the Agency did not believe the company’s application had provided substantial evidence of efficacy to warrant approval, and advised Chiasma that it would need to conduct another clinical trial in order to overcome this deficiency.
For more details, go to: http://ir.chiasmapharma.com/phoenix.zhtml?c=254057&p=irol-newsArticle&ID=2157743