By Amira McKee

Shares of Protalix BioTherapeutics jumped after the European Medicines Agency's Committee for Medicinal Products for Human Use issued a positive opinion on a new dosing regimen of its Fabry disease treatment.

The stock rose 7.9% to $2.53 in Monday morning trading. The shares have increased 3% in the past year.

The biopharmaceutical company focused on rare diseases said Monday that the committee gave a positive opinion of a new dosing regimen of 2 mg per kilogram every four weeks for Protalix's Elfabrio drug.

Elfabrio is an enzyme-replacement therapy designed to treat adults with Fabry disease, a rare genetic disorder that prevents the body from breaking down a fatty substance called globotriaosylceramide, causing it to build up in cells and damage organs.

The opinion will be reviewed by the European Commission with a decision anticipated by March. If approved, Elfabrio will be available in two doses, including the already approved regimen of 1 mg per kilogram every two weeks, to patients in the European Union.

Protalix, and its collaborator Chiesi Global's rare diseases unit, said the new regimen could reduce the burden to eligible patients and their families by alleviating the current requirement to visit infusion centers every two weeks for treatment. The new dosing regimen is not approved in U.S.

Write to Amira McKee at amira.mckee@wsj.com

(END) Dow Jones Newswires

February 02, 2026 11:00 ET (16:00 GMT)

Copyright (c) 2026 Dow Jones & Company, Inc.