Pink Sheet 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

BrainStorm’s Phase III Data Do Not Support Clinical Benefit Of NurOwn In ALS, US FDA Says

Executive Summary

Agency’s unusual public statement about an investigational product's development status may be aimed at countering bullish comments from the sponsor; FDA cites failure of pivotal trial on the primary and secondary endpoints and ‘modest excess in deaths’ with the cell therapy.

You may also be interested in...



BrainStorm's Cell Therapy Disappoints In Phase III ALS Study

Top-line results from BrainStorm’s NurOwn Phase III ALS study show the cell therapy missed the primary efficacy endpoint, but clinically meaningful responses were seen in a pre-specified subgroup which investigators considered potentially a significant step forward in therapy.

US FDA Reassures ALS Patients In Final Development Guidance

ALS advocates succeed in getting the FDA to soften its stance on use of randomized, placebo-controlled trials for drug development; final guidance also encourages patient-reported outcomes.

Disease-Specific Guidances Reflect US FDA's 'Nimble, Collaborative, Patient-Focused' Approach

Patient groups helped with draft guidance on ALS drug development and revision of Alzheimer's draft guidance; agency also issues draft guidance on pediatric seizure, final guidances on DMD and migraine.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

PS143884

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