BrainsWay Shares Rise on FDA Clearance of Major Depressive Disorder Treatment
By Nicholas G. Miller
Shares of BrainsWay rose after the Food and Drug Administration approved an accelerated treatment protocol for its brain stimulation therapy to treat depression.
The stock rose 11% to $16.79 and is now up 78% so far this year.
The FDA clearance expands the acceptable protocols for BrainsWay's deep transcranial magnetic stimulation, a non-invasive treatment used to treat patients with major depressive disorder, including those with comorbid anxiety symptoms.
While previous FDA clearance involved four weeks of daily treatment before follow up visits, the new clearance allows for an accelerated protocol of six treatment days.
The company said it is seeking updates to insurance reimbursement to match the new accelerated protocol. The current reimbursement for deep TMS therapy only allows for two treatments a day.
The clearance comes following a clinical study that showed the accelerated protocol resulted in comparable results to the standard protocol with fewer visits to the clinic.
Write to Nicholas G. Miller at nicholas.miller@wsj.com.
(END) Dow Jones Newswires
September 16, 2025 13:03 ET (17:03 GMT)
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