BrainsWay Soars Following FDA Approval of Accelerated Deep TMS Protocol
FDA Approval: BrainsWay's shares surged after the U.S. FDA approved an accelerated treatment protocol for its Deep Transcranial Magnetic Stimulation (Deep TMS) system, aimed at patients with major depressive disorder (MDD).
Treatment Expansion: The new protocol, based on intermittent theta burst stimulation (iTBS), allows for effective treatment with fewer clinical visits, marking a significant advancement in depression therapy, according to CEO Hadar Levy.
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Wall Street Analysts Adjust Ratings on Key Stocks
- SLB Price Target Increase: B of A Securities raised the price target for SLB NV from $50 to $55, with analyst Chase Mulvehill maintaining a Buy rating, indicating confidence in the company's future growth, as SLB shares closed at $49.15 on Friday.
- Meta Rating Upgrade: Rothschild & Co increased the price target for Meta Platforms from $740 to $900 and upgraded the rating from Neutral to Buy, reflecting optimism about its long-term growth potential, with Meta shares closing at $658.76 on Friday.
- Cisco Price Target Boost: Evercore ISI Group raised Cisco Systems' price target from $80 to $100, with analyst Amit Daryanani upgrading the rating from In-Line to Outperform, suggesting positive expectations for its market performance, as Cisco shares closed at $74.59 on Friday.
- Microsoft Price Target Cut: B of A Securities lowered Microsoft's price target from $640 to $520, yet analyst Brad Sills maintained a Buy rating, demonstrating ongoing confidence in the company's fundamentals, with Microsoft shares closing at $465.95 on Friday.
BrainsWay Secures Expanded Coverage for Depression Treatment from Highmark
- Policy Expansion: Highmark Blue Cross Blue Shield has released a draft policy expanding coverage to include adolescent and adult patients with major depressive disorder, expected to take effect in February 2026, marking a significant advancement for BrainsWay in depression treatment.
- Accelerated Treatment Protocol: The new policy includes BrainsWay's accelerated SWIFT™ protocol, which consists of five treatment sessions per day for six days, significantly reducing patient clinic visits and enhancing treatment accessibility and flexibility.
- Clinical Efficacy: BrainsWay's accelerated Deep TMS protocol received FDA clearance in September 2025, with clinical trials demonstrating an 87.8% response rate and a 78.0% remission rate, indicating comparable efficacy to standard Deep TMS and strengthening its market competitiveness.
- Market Outlook: With the implementation of this policy, BrainsWay is poised to attract more insurers to adopt its treatment protocols, further promoting the acceptance and accessibility of Deep TMS technology, thereby enhancing the company's leadership position in the mental health sector.
BrainsWay (BWAY) Receives FDA Approval for Proliv™Rx System for Depression Treatment
- Regulatory Milestone: BrainsWay's Proliv™Rx system has received FDA Premarket Approval, becoming the first home-use neuromodulation device for treatment-resistant major depressive disorder, underscoring the company's leadership in non-invasive brain stimulation technologies.
- Market Expansion Opportunity: This approval not only allows BrainsWay to enter the home care market but also significantly broadens its potential customer base by providing more accessible treatment options, enhancing the company's market share in mental health.
- Strategic Investment: BrainsWay's investment in Neurolief includes an acquisition option, aimed at leveraging the synergies between both companies' commercial and research infrastructures to enhance its value proposition and increase overall market coverage.
- Technological Innovation: The launch of the Proliv™Rx device reflects BrainsWay's commitment to data-driven mental health care, further solidifying its leadership in integrating multiple treatment modalities and advancing the realization of the company's long-term vision.
BrainsWay to Host Virtual Analyst & Investor Day on December 1, 2025
- Strategic Investor Day: BrainsWay will host a virtual Analyst & Investor Day on December 1, 2025, where management will highlight the company's growth strategy, potentially attracting investor interest in its Deep TMS technology market potential.
- Expert Participation: The event will feature Dr. Owen Scott Muir, Chief Medical Officer of Radial, who will share his clinical experience with Deep TMS, emphasizing the technology's importance in addressing mental health needs, which may enhance the company's authority in the industry.
- Clinical Innovation Showcase: BrainsWay will present its patented Deep TMS treatment and the potential impact of its accelerated protocol aimed at improving symptoms of various mental health issues, including depression and OCD, further solidifying its market leadership.
- Q&A Session Arrangement: A live question and answer session will follow the formal presentations, providing attendees with an opportunity to interact with management, potentially boosting investor confidence in the company's future developments.
BrainsWay Obtains FDA Approval for Deep TMS™ as Additional Treatment for Major Depressive Disorder in Teens Aged 15 to 21
FDA Approval: BrainsWay Ltd. announced that the FDA has expanded the label for its Deep TMS™ system to include treatment for adolescents aged 15 to 21 with major depressive disorder (MDD), addressing a critical gap in mental health care for this age group.
Clinical Evidence: The FDA's clearance was supported by a substantial dataset from 1,120 adolescents treated across 35 centers, showing significant improvements in depressive and anxiety symptoms after 36 treatment sessions.
Market Impact: This approval allows BrainsWay to treat both adults and adolescents with the same Deep TMS™ system, potentially reaching a significant number of the estimated 5 million adolescents in the U.S. who have experienced a major depressive episode.
Company Commitment: BrainsWay is dedicated to advancing noninvasive neurostimulation treatments and is actively conducting clinical trials for various psychiatric and neurological disorders, reinforcing its position as a leader in evidence-based mental health therapies.
Northland Capital Markets Reaffirms Outperform Rating for BrainsWay, Increases Price Target to $23
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Market Winning Tools: Benzinga Pro equips traders with tools and information to improve their chances of success in the stock market.
Wall Street Analysts Adjust Ratings on Key Stocks
- SLB Price Target Increase: B of A Securities raised the price target for SLB NV from $50 to $55, with analyst Chase Mulvehill maintaining a Buy rating, indicating confidence in the company's future growth, as SLB shares closed at $49.15 on Friday.
- Meta Rating Upgrade: Rothschild & Co increased the price target for Meta Platforms from $740 to $900 and upgraded the rating from Neutral to Buy, reflecting optimism about its long-term growth potential, with Meta shares closing at $658.76 on Friday.
- Cisco Price Target Boost: Evercore ISI Group raised Cisco Systems' price target from $80 to $100, with analyst Amit Daryanani upgrading the rating from In-Line to Outperform, suggesting positive expectations for its market performance, as Cisco shares closed at $74.59 on Friday.
- Microsoft Price Target Cut: B of A Securities lowered Microsoft's price target from $640 to $520, yet analyst Brad Sills maintained a Buy rating, demonstrating ongoing confidence in the company's fundamentals, with Microsoft shares closing at $465.95 on Friday.
BrainsWay Secures Expanded Coverage for Depression Treatment from Highmark
- Policy Expansion: Highmark Blue Cross Blue Shield has released a draft policy expanding coverage to include adolescent and adult patients with major depressive disorder, expected to take effect in February 2026, marking a significant advancement for BrainsWay in depression treatment.
- Accelerated Treatment Protocol: The new policy includes BrainsWay's accelerated SWIFT™ protocol, which consists of five treatment sessions per day for six days, significantly reducing patient clinic visits and enhancing treatment accessibility and flexibility.
- Clinical Efficacy: BrainsWay's accelerated Deep TMS protocol received FDA clearance in September 2025, with clinical trials demonstrating an 87.8% response rate and a 78.0% remission rate, indicating comparable efficacy to standard Deep TMS and strengthening its market competitiveness.
- Market Outlook: With the implementation of this policy, BrainsWay is poised to attract more insurers to adopt its treatment protocols, further promoting the acceptance and accessibility of Deep TMS technology, thereby enhancing the company's leadership position in the mental health sector.
BrainsWay (BWAY) Receives FDA Approval for Proliv™Rx System for Depression Treatment
- Regulatory Milestone: BrainsWay's Proliv™Rx system has received FDA Premarket Approval, becoming the first home-use neuromodulation device for treatment-resistant major depressive disorder, underscoring the company's leadership in non-invasive brain stimulation technologies.
- Market Expansion Opportunity: This approval not only allows BrainsWay to enter the home care market but also significantly broadens its potential customer base by providing more accessible treatment options, enhancing the company's market share in mental health.
- Strategic Investment: BrainsWay's investment in Neurolief includes an acquisition option, aimed at leveraging the synergies between both companies' commercial and research infrastructures to enhance its value proposition and increase overall market coverage.
- Technological Innovation: The launch of the Proliv™Rx device reflects BrainsWay's commitment to data-driven mental health care, further solidifying its leadership in integrating multiple treatment modalities and advancing the realization of the company's long-term vision.
BrainsWay to Host Virtual Analyst & Investor Day on December 1, 2025
- Strategic Investor Day: BrainsWay will host a virtual Analyst & Investor Day on December 1, 2025, where management will highlight the company's growth strategy, potentially attracting investor interest in its Deep TMS technology market potential.
- Expert Participation: The event will feature Dr. Owen Scott Muir, Chief Medical Officer of Radial, who will share his clinical experience with Deep TMS, emphasizing the technology's importance in addressing mental health needs, which may enhance the company's authority in the industry.
- Clinical Innovation Showcase: BrainsWay will present its patented Deep TMS treatment and the potential impact of its accelerated protocol aimed at improving symptoms of various mental health issues, including depression and OCD, further solidifying its market leadership.
- Q&A Session Arrangement: A live question and answer session will follow the formal presentations, providing attendees with an opportunity to interact with management, potentially boosting investor confidence in the company's future developments.
BrainsWay Obtains FDA Approval for Deep TMS™ as Additional Treatment for Major Depressive Disorder in Teens Aged 15 to 21
FDA Approval: BrainsWay Ltd. announced that the FDA has expanded the label for its Deep TMS™ system to include treatment for adolescents aged 15 to 21 with major depressive disorder (MDD), addressing a critical gap in mental health care for this age group.
Clinical Evidence: The FDA's clearance was supported by a substantial dataset from 1,120 adolescents treated across 35 centers, showing significant improvements in depressive and anxiety symptoms after 36 treatment sessions.
Market Impact: This approval allows BrainsWay to treat both adults and adolescents with the same Deep TMS™ system, potentially reaching a significant number of the estimated 5 million adolescents in the U.S. who have experienced a major depressive episode.
Company Commitment: BrainsWay is dedicated to advancing noninvasive neurostimulation treatments and is actively conducting clinical trials for various psychiatric and neurological disorders, reinforcing its position as a leader in evidence-based mental health therapies.
Northland Capital Markets Reaffirms Outperform Rating for BrainsWay, Increases Price Target to $23
Real-time Intelligence: Benzinga Pro offers the fastest news alerts for traders to stay updated on market movements.
Exclusive Stories: The platform provides unique stories generated by Benzinga reporters, enhancing the trading experience for its users.
Community of Traders: Over 10,000 serious traders are part of the Benzinga Pro community, sharing insights and strategies.
Market Winning Tools: Benzinga Pro equips traders with tools and information to improve their chances of success in the stock market.
