Amylyx Shares Rally Premarket on FDA Approval of ALS Drug

By Colin Kellaher

Shares of Amylyx Pharmaceuticals Inc. rose sharply in premarket trading Friday after the U.S. Food and Drug Administration approved Relyvrio, the company's new drug for amyotrophic lateral sclerosis, or ALS.

The drug is the first in five years to win an FDA green light for ALS, a progressive neurodegenerative disease also known as Lou Gehrig's disease.

Analyst Neena Bitritto-Garg at Citi said she expects demand for Relyvrio will be very strong at launch, with potential for meaningful out-performance versus Wall Street's expectations.

She termed the label for the label for Relyvrio as broad and clean, noting that it makes the drug the only approved ALS therapy with both a function and survival benefit on the label.

Cambridge, Mass., biopharmaceutical company Amylyx said doctors can begin prescribing Relyvrio immediately, adding that it expects specialty pharmacies will be able to start filling prescriptions and shipping the drug in the next four to six weeks.

Amylyx shares, which closed Thursday at $30.19, were recently up 7.7% to $32.51 in premarket trading.

Write to Colin Kellaher at [e-mail]

(END) Dow Jones Newswires

09-30-22 0615ET