Scrip is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

Chiasma Responds To FDA Complete Response With 33% Staff Cut

Executive Summary

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...



Finance Watch: Amarin Raises Cash To Boost Vascepa Marketing Under Soon-To-Be Expanded Label

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.

Finance Watch: NGM Bio Is Second NASH IPO In Two Weeks

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.

FDA Mycapssa Snub Whacks Chiasma; New Study Needed

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.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

ID1132327

Ask The Analyst

Please Note: Click here for more information on the Ask the Analyst service.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel