BrainsWay Shares Rise 25% After FDA Clearance for Depression Treatment
18 Agosto 2021 - 4:45PM
Dow Jones News
By Chris Wack
BrainsWay Ltd. shares rose 25% to $9.52 after the company said
it received 510(k) clearance from the U.S. Food and Drug
Administration, allowing it to market its Deep Transcranial
Magnetic Stimulation System for the reduction of comorbid anxiety
symptoms in adult patients with depression.
The company said data from 573 patients who had undergone Deep
TMS treatment in 11 studies, including both randomized controlled
trials and open-label studies, was submitted by BrainsWay in
support of its application to the FDA. The data demonstrated a
treatment effect that was consistent, robust, and clinically
meaningful for decreasing anxiety symptoms in adult patients
suffering from major depressive disorder.
An analysis of the BrainsWay data found favorable outcomes with
Deep TMS when compared to sham or medication as standard of
care.
The expanded FDA labeling now allows BrainsWay to market its
Deep TMS System for the treatment of depressive episodes and for
decreasing anxiety symptoms for those who may exhibit comorbid
anxiety symptoms in adult patients suffering from major depressive
disorder and who failed to achieve satisfactory improvement from
previous antidepressant medication treatment in the current
episode.
Write to Chris Wack at chris.wack@wsj.com
(END) Dow Jones Newswires
August 18, 2021 10:30 ET (14:30 GMT)
Copyright (c) 2021 Dow Jones & Company, Inc.
Grafico Azioni Brainsway (NASDAQ:BWAY)
Storico
Da Set 2024 a Ott 2024
Grafico Azioni Brainsway (NASDAQ:BWAY)
Storico
Da Ott 2023 a Ott 2024