In Vivo is part of the Business Intelligence Division 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

FDA: Ph III needed before Arikayce NDA; Insmed plummets

This article was originally published in Scrip

Executive Summary

Shares of Insmed plunged 27% on 4 August after it disclosed the FDA said Phase III data would be needed to support a new drug application (NDA) for Arikayce (liposomal amikacin for inhalation), formerly known as Arikace, as a treatment for nontuberculous mycobacteria (NTM) lung infections, declaring the firm's single Phase II trial was not sufficient for an accelerated approval – especially since it missed its primary endpoint.

Advertisement

Related Content

Insmed Phase III Date Support Accelerated Approval For ALIS In Rare Lung Disease
ALIS In Wonderland: Insmed Reaches Fairy Tale Heights On Lung Disease Results

Topics

Related Companies

Advertisement
UsernamePublicRestriction

Register

SC025981

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

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