×
Newsmax TV & Webwww.newsmax.comFREE - In Google Play
VIEW
×
Newsmax TV & Webwww.newsmax.comFREE - On the App Store
VIEW
Tags: als | fda | amylyx | medication | approval

FDA to Reconvene Experts' Meeting to Review ALS Drug

ALS labels with medication, stethoscope around it
(Dreamstime)

Tuesday, 05 July 2022 10:06 AM EDT

Amylyx Pharmaceuticals said on Tuesday the U.S. Food and Drug Administration (FDA) will reconvene a meeting of its outside experts to review the company's application seeking approval for its amyotrophic lateral sclerosis (ALS) treatment.

A panel of outside advisers to the U.S. FDA in March voted six to four against its oral drug, AMX0035, saying the company's clinical study data failed to establish it was effective against ALS.

Shares of the company, which said the next meeting on Sept. 7 will focus on additional analyzes from its clinical studies, jumped nearly 10% to $21.41 before the bell.

ALS, whose cause is largely unknown, leads nerve cells in the brain and spinal cord to break down, affecting physical function, resulting in severe disability and even death.

FDA's decision on the drug, which was approved in Canada in June, is expected by Sept. 29.

© 2022 Thomson/Reuters. All rights reserved.


Health-News
Amylyx Pharmaceuticals said on Tuesday the U.S. Food and Drug Administration (FDA) will reconvene a meeting of its outside experts to review the company's application seeking approval for its amyotrophic lateral sclerosis (ALS) treatment. A panel of outside advisers to the...
als, fda, amylyx, medication, approval
142
2022-06-05
Tuesday, 05 July 2022 10:06 AM
Newsmax Media, Inc.

Sign up for Newsmax’s Daily Newsletter

Receive breaking news and original analysis - sent right to your inbox.

(Optional for Local News)
Privacy: We never share your email address.
Join the Newsmax Community
Read and Post Comments
Please review Community Guidelines before posting a comment.
 
Find Your Condition
Get Newsmax Text Alerts
TOP

The information presented on this website is not intended as specific medical advice and is not a substitute for professional medical treatment or diagnosis. Read Newsmax Terms and Conditions of Service.

Newsmax, Moneynews, Newsmax Health, and Independent. American. are registered trademarks of Newsmax Media, Inc. Newsmax TV, and Newsmax World are trademarks of Newsmax Media, Inc.

NEWSMAX.COM
© Newsmax Media, Inc.
All Rights Reserved
NEWSMAX.COM
© Newsmax Media, Inc.
All Rights Reserved