Depression

NeuroStar® Advanced Therapy Receives FDA Clearance as a First-Line Add-On Treatment for Adolescents with Depression

Retrieved on: 
Monday, March 25, 2024

NeuroStar is the first and only transcranial magnetic stimulation (TMS) treatment FDA-cleared for this age group, making it the fourth FDA-cleared indication for NeuroStar.

Key Points: 
  • NeuroStar is the first and only transcranial magnetic stimulation (TMS) treatment FDA-cleared for this age group, making it the fourth FDA-cleared indication for NeuroStar.
  • "The prevalence of depression in adolescents and young adults has been accelerating since the COVID-19 pandemic.
  • "NeuroStar’s TMS therapy now offers a promising first-line treatment for adolescents, backed by real-world data and impressive response rates consistent with response rates for adults.
  • This advancement has the potential to set a new treatment paradigm for how we address depression in our youth."

Impressive $3.3M investment in Basic Mental Health Research

Retrieved on: 
Tuesday, March 19, 2024

Basic research is scientific research carried out primarily to expand knowledge and understanding rather than to directly address clinical or practical issues.

Key Points: 
  • Basic research is scientific research carried out primarily to expand knowledge and understanding rather than to directly address clinical or practical issues.
  • The Basics of Better Mental Health Program funds basic research that will provide insight into the causes and onset of mental health conditions, explore the neuropathological changes and information-processing deficits that may eventually lead to new directions for treatments and interventions, and explore the role of sex and gender in mental health.
  • "Brain research plays a critical role in increasing our understanding of the causes and onset of mental health conditions,” says the Honourable Ya’ara Saks, Minister of Mental Health and Addictions.
  • “I am thrilled to support the work being done through the Basics of Better Mental Health Program – this work will support better mental health for all Canadians.”
    “The inclusion of sex-specific biological considerations is instrumental in understanding the biological roots of mental health conditions,” says Dr. Viviane Poupon, President and CEO of Brain Canada.

Axsome Therapeutics Initiates PARADIGM Phase 3 Trial of Solriamfetol for the Treatment of Major Depressive Disorder

Retrieved on: 
Tuesday, March 19, 2024

NEW YORK, March 19, 2024 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders, today announced the first patient has been dosed in the PARADIGM Phase 3 trial of solriamfetol, an investigational treatment for major depressive disorder (MDD).

Key Points: 
  • NEW YORK, March 19, 2024 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders, today announced the first patient has been dosed in the PARADIGM Phase 3 trial of solriamfetol, an investigational treatment for major depressive disorder (MDD).
  • PARADIGM (Progressing TAAR-1, Dopamine, and Norepinephrine in Depression Using Solriamfetol) is a Phase 3, randomized, double-blind, placebo-controlled, multicenter trial to assess the efficacy and safety of solriamfetol for the treatment of MDD in adults.
  • Approximately 300 patients will be randomized in a 1:1 ratio to receive solriamfetol (300 mg) or placebo for 6 weeks.
  • The primary endpoint will be change in the Montgomery Åsberg Depression Rating Scale (MADRS).

WaveDancer and Firefly Neuroscience, an AI-Driven Brain Health Company, Each Receive Respective Stockholder Approvals for Merger

Retrieved on: 
Monday, March 18, 2024

FAIRFAX, Va., March 18, 2024 (GLOBE NEWSWIRE) -- WaveDancer, Inc. (“WaveDancer”) (Nasdaq: WAVD) and Firefly Neuroscience, Inc. (“Firefly”) an AI-driven brain health company, each received the requisite stockholder approvals required to consummate the merger between both companies.

Key Points: 
  • FAIRFAX, Va., March 18, 2024 (GLOBE NEWSWIRE) -- WaveDancer, Inc. (“WaveDancer”) (Nasdaq: WAVD) and Firefly Neuroscience, Inc. (“Firefly”) an AI-driven brain health company, each received the requisite stockholder approvals required to consummate the merger between both companies.
  • The Firefly approval was obtained through a written consent by the holders of a majority of the outstanding voting shares of Firefly.
  • "The WaveDancer favorable shareholder vote is an important step in consummating the merger and reinventing WaveDancer as an AI-enabled neurological health platform,” said Jamie Benoit, Chairman and CEO of WaveDancer.
  • WaveDancer has filed with the SEC a Registration Statement, which includes a proxy statement/prospectus of WaveDancer that sets forth relevant information pertaining to the merger.

Cortexa Leads the World in First Supply of Psilocybin Under the TGA’s Authorized Prescriber Scheme

Retrieved on: 
Monday, March 18, 2024

Ltd. (Cortexa), in what is an Australian and the Company believes a world first, has supplied GMP Psilocybin for therapeutic use outside of a clinical trial to a patient under the authorised prescriber scheme.

Key Points: 
  • Ltd. (Cortexa), in what is an Australian and the Company believes a world first, has supplied GMP Psilocybin for therapeutic use outside of a clinical trial to a patient under the authorised prescriber scheme.
  • The patient was being treated with Psilocybin for treatment resistant depression.
  • In doing so, Cortexa is now established as the only Australian company able to immediately supply and deliver both GMP MDMA and Psilocybin for both clinical trials and prescriptions via the TGA’s Authorised Prescriber Scheme.
  • Cortexa has created a national network of relationships with research institutes, key opinion leaders and emerging clinicians, and supported psychiatrists for obtaining their authorised prescriber status.

BrainsWay Broadens Partnership with Katie’s Way Plus Through Order of an Additional 18 Deep TMS™ Systems

Retrieved on: 
Monday, March 18, 2024

Katie’s Way Plus will now grow to an extensive network of approximately 40 Deep TMS systems.

Key Points: 
  • Katie’s Way Plus will now grow to an extensive network of approximately 40 Deep TMS systems.
  • “We are delighted to continue supporting Katie's Way Plus in its pivotal mission of delivering specialized care to U.S. service members, veterans, and their families,” said Chris Boyer, BrainsWay’s Vice President of Marketing.
  • “The efficacy demonstrated by BrainsWay's advanced Deep TMS technology in the treatment of depression is transformational.
  • In one study conducted across 27 states, it was found that the suicide rate among veterans is 50% higher than non-veterans1.

Nexalin Technology Announces Poster Presentation at “State of the Technology Meeting: Neurotrauma Diagnosis, Monitoring, and Assessment”

Retrieved on: 
Wednesday, March 13, 2024

HOUSTON, TEXAS, March 13, 2024 (GLOBE NEWSWIRE) -- Nexalin Technology, Inc. (the “Company” or “Nexalin”) (Nasdaq: NXL; NXLIW), today announced it was selected and provided a poster presentation at the “State of the Technology Meeting: Neurotrauma Diagnosis, Monitoring, and Assessment” on March 12, 2024, which was held at the Walter E. Washington Convention Center in Washington, D.C.

Key Points: 
  • The U.S. Army Medical Research and Development Command’s (USAMRDC) Combat Casualty Care Research Program (CCCRP) Neurotrauma Portfolio and the Biomedical Advanced Research and Development Authority (BARDA), with support of MTEC, hosted the State of the Technology meeting focused on non-invasive neuroassessment tools.
  • This was an ideal venue for our poster presentation as the conference attendees included many of the leading thought leaders and decision-makers from both the public and private sectors.
  • Notably, both the DoD and BARDA’s concerns continue to grow surrounding TBI, and we’re seeing the US Government significantly invest in new, non-drug therapeutic options to address TBI in support of struggling warfighters and veterans.
  • We could not have been more pleased with the overwhelming response to our presentation and look forward to providing more details on our latest study in an upcoming abstract publication.”

Special Needs Network Secures Over $1 Million in Grant Funding for Groundbreaking Mental Health Initiative

Retrieved on: 
Tuesday, March 12, 2024

This program aims to address the disparities in autism identification and services, particularly among African American and LatinX students.

Key Points: 
  • This program aims to address the disparities in autism identification and services, particularly among African American and LatinX students.
  • Furthermore, SNN has received a $750,000 grant from the California Department of Health Services (DHCS) as part of the California Youth Behavioral Health (CYBH) initiative, dedicated to supporting mental health initiatives for youth.
  • This funding will bolster SNN's efforts to deliver culturally competent, anti-racist behavioral health services right in the communities that need them ymost.
  • Special Needs Network, Inc. is a nonprofit grassroots 501(c)(3) organization responding to the crisis of autism and other developmental disabilities in underserved communities.

Ancora Issues Letter to Fellow Shareholders Regarding Norfolk Southern’s Failures of Diligence and Poor Judgment in Appointing John Orr as COO

Retrieved on: 
Friday, April 5, 2024

Ohio-based Ancora Holdings Group, LLC (collectively with its affiliates, “Ancora” or “we”), which owns a large equity stake in Norfolk Southern Corporation (NYSE: NSC) (“Norfolk Southern” or the “Company”), today issued the below letter to fellow shareholders regarding the Board of Directors’ (the “Board”) apparent failures of diligence and poor judgment in appointing John Orr as COO.

Key Points: 
  • Ohio-based Ancora Holdings Group, LLC (collectively with its affiliates, “Ancora” or “we”), which owns a large equity stake in Norfolk Southern Corporation (NYSE: NSC) (“Norfolk Southern” or the “Company”), today issued the below letter to fellow shareholders regarding the Board of Directors’ (the “Board”) apparent failures of diligence and poor judgment in appointing John Orr as COO.
  • Ancora is a sizable shareholder of Norfolk Southern, meaning our interests and your interests are squarely aligned.
  • The Board and Mr. Shaw provided CPKC with excessive financial and strategic consideration that weakens Norfolk Southern’s long-term competitive positioning.
  • Norfolk Southern operated from a position of desperation, and shareholders and other stakeholders now stand to pay a steep price.

Otsuka Works with Verily to Launch Longitudinal Mental Health Registry to Advance Novel Research in Psychiatry

Retrieved on: 
Thursday, April 4, 2024

Otsuka Pharmaceutical Development & Commercialization, Inc. (Otsuka), a global pharmaceutical company, announces the launch of My Mental Health Journey , a longitudinal registry study that aims to advance research in depression and mental health.

Key Points: 
  • Otsuka Pharmaceutical Development & Commercialization, Inc. (Otsuka), a global pharmaceutical company, announces the launch of My Mental Health Journey , a longitudinal registry study that aims to advance research in depression and mental health.
  • Verily Life Sciences LLC (Verily), a precision health technology company, will recruit participants and run the study.
  • View the full release here: https://www.businesswire.com/news/home/20240404726198/en/
    The My Mental Health Journey registry will enroll U.S.-based adults experiencing symptoms of depression to help Otsuka better understand mental health conditions, such as major depressive disorder, across time and in the real-world setting.
  • Participants in the My Mental Health Journey may receive compensation for study activities, educational resources, updates on future clinical studies, and other opportunities to help advance depression research.