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CHIASMA: Fda Issues Complete Response Letter For Mycapssa New Drug Application

The following excerpt is from the company's SEC filing.

WALTHAM, Mass., April 15, 2016

Chiasma, Inc. (NASDAQ: CHMA), a late-stage biopharmaceutical company focused on improving the lives of patients with rare and serious chronic diseases, today announced that it received a Complete Response Letter (CRL) from the United States (U.S.) Food and Drug Administration (FDA) regarding the companys New Drug Application for Mycapssa (octreotide) capsules for the maintenance treatment of U.S. adult patients with acromegaly. The FDA issues CRLs to indicate that the review cycle for an application is complete and that the application is not ready for approval in its present form. Chiasma is reviewing the FDA communication and plans to provide an additional update before market open on Monday, April 18, 2016.

Conference Call

At 8:30 a.m. Eastern Time on Monday, April 18, 2016, Chiasmas senior management team will host a conference call to discuss the FDAs decision. Investors can access a live and archived webcast of this call via the News & Investors section of the companys website, www.ChiasmaPharma.com. Individuals may also participate in the live call via telephone by dialing (877) 317-6789 (domestic) or (412) 317-6789 (international) and may access a teleconference replay for one week by dialing (877) 344-7529 (domestic) or (412) 317-0088 (international) and using confirmation code 10084436.

About Mycapssa

Mycapssa is an investigational new oral drug proposed for the maintenance therapy of adult patients with acromegaly. If approved, octreotide capsules may be the first oral somatostatin analog approved for acromegaly. Octreotide capsules...


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