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Brainsway (BWAY) FDA Events

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FDA Events for Brainsway (BWAY)

This section highlights FDA-related milestones and regulatory updates for drugs developed by Brainsway (BWAY). Over the past two years, Brainsway has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as Deep. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

Deep TMS - FDA Regulatory Timeline and Events

Deep TMS is a drug developed by Brainsway for the following indication: Decreasing Anxiety Symptoms in Depressed Patients. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

Brainsway FDA Events - Frequently Asked Questions

As of now, Brainsway (BWAY) has not received any FDA approvals for its therapy in the last two years.

In the past two years, Brainsway (BWAY) has reported FDA regulatory activity for Deep TMS.

The most recent FDA-related event for Brainsway occurred on June 11, 2025, involving Deep TMS. The update was categorized as "Preliminary Results," with the company reporting: "BrainsWay Ltd. announced preliminary results from a multicenter, randomized controlled trial titled, "Accelerated Deep TMS for Depression: Results from a Multisite, Randomized Non-Inferiority Trial.""

Currently, Brainsway has one therapy (Deep TMS) targeting the following condition: Decreasing Anxiety Symptoms in Depressed Patients.

More FDA Event Resources from MarketBeat

  • NDA: New Drug Application
  • ANDA: Abbreviated New Drug Application
  • sNDA: Supplemental New Drug Application
  • BLA: Biologics License Application
  • sBLA: Supplemental Biologics License Application
  • FDA Approved: Approved by the FDA
  • EMA: European Medicines Agency
  • CE Mark: European Union Certification
  • NMPA: China National Medical Products Administration
  • MHLW: Japanese Ministry of Health
  • FDA Meeting: Consultation with FDA
  • Pre-IND: Pre-Investigational New Drug Meeting
  • Breakthrough Therapy: Special FDA designation for promising therapies
  • Fast Track: Accelerated FDA approval pathway
  • Orphan Drug: Designation for rare disease treatments
  • RPD: Rare Pediatric Disease Designation
  • RMAT: Regenerative Medicine Advanced Therapy
  • DSMB Review: Data Safety Monitoring Board Review
  • IDMC Review: Independent Data Monitoring Committee
  • MAA: MHRA Marketing Authorization Application
  • RTF: Refusal to File (Rejected Application)
  • 510(k): FDA Clearance for Medical Devices
  • Rolling Submission: Staggered regulatory review process

This page (NASDAQ:BWAY) was last updated on 7/11/2025 by MarketBeat.com Staff
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