Chiasma Responds To FDA Complete Response With 33% Staff Cut
With a near-term launch of Mycapssa unlikely, Chiasma cuts its commercial staff while it evaluates how to respond to an April complete response letter.
You may also be interested in...
Public Company Edition: Two months before the deadline for the company's sNDA, the US FDA has not indicated it will hold an advisory committee meeting for the triglyceride-lowering drug. Also, Seattle Genetics raises $575m, Atara and Ra bring in $150m each and Cara completes $145.5m offering.
Public Company Edition: NGM went public a week after Genfit, but endured a rockier start, trading below its IPO price. Also, Blueprint, Tricida and Sangamo launch large offerings after positive clinical and regulatory updates.
The FDA tried to warn Chiasma Inc. in 2014 its single-arm, open-label Phase III trial may not be enough to pass muster for the agency to approve the company's new drug application (NDA) for its investigational acromegaly drug Mycapssa (octreotide) and pointed out having a controlled trial would be a better option.