MDD

Nexalin Technology Unveils Next-Generation HALO™ Clarity

Retrieved on: 
Thursday, January 11, 2024
Patient, TBI, Privacy, Research, PTSD, Post-traumatic stress disorder, History, Food, FDA, Physician, Traumatic brain injury, Chronic pain, MDD, Pharmaceutical industry

HOUSTON, TEXAS, Jan. 11, 2024 (GLOBE NEWSWIRE) -- Nexalin Technology, Inc. (the “Company” or “Nexalin”) (Nasdaq: NXL; NXLIW) today unveiled its Gen-3 HALO™ Clarity 15 milliamp (mA) neurostimulation device designed to treat a variety of mental health conditions, including Major Depressive Disorder (MDD), addiction and substance use disorder, Alzheimer’s disease, traumatic brain injury (TBI), post-traumatic stress disorder (PTSD), chronic pain and other potentially-applicable stress-related neuropsychiatric disorders.

Key Points: 
  • The HALO™ Clarity utilizes an advanced technique, Deep Intracranial Frequency Stimulation (DIFS™), to penetrate structures deep in the mid-brain that are associated with mental health disorders.
  • Nexalin believes that this innovative technique in its next-generation devices will generate enhanced patient therapeutic responses without adverse side effects.
  • The HALO™ Clarity device has been the subject of multiple clinical trials in China whose findings were published in medical journals.
  • Mark White, CEO of Nexalin Technology, stated, “The HALO™ Clarity marks a significant advance and possibly the most meaningful event in the history of the Company.

AIRS Medical Receives EU Medical Device Regulation CE Certification for SwiftMR™

Retrieved on: 
Thursday, January 11, 2024
MRI, MDR, Theatre, AI, Regulation, Medical device, Safety, Congress, Certification, FDA, ECR, CE, MDD

SEOUL, South Korea, Jan. 11, 2024 /PRNewswire/ -- AIRS Medical, a leading AI-powered healthcare solution provider, is thrilled to announce that it has received EU Medical Device Regulation (MDR) CE certification for its AI-powered MRI enhancement solution 'SwiftMR™'.

Key Points: 
  • SEOUL, South Korea, Jan. 11, 2024 /PRNewswire/ -- AIRS Medical, a leading AI-powered healthcare solution provider, is thrilled to announce that it has received EU Medical Device Regulation (MDR) CE certification for its AI-powered MRI enhancement solution 'SwiftMR™'.
  • The MDR CE certification is a more stringent requirement for medical devices than the previous Medical Device Directive (MDD), ensuring higher performance, quality standards, safety and clinical evaluation.
  • MDR CE certification is essential for sales in EU and neighboring countries based on CE certification.
  • Hyeseong Lee, CEO of AIRS Medical, stated, "Our MDR CE certification clearly shows AIRS Medical's capabilities in product quality and regulatory compliance."

Xenon Pharmaceuticals Outlines Key Milestone Opportunities for 2024

Retrieved on: 
Monday, January 8, 2024
SCN1A, Drug discovery, DSM-IV codes, IND, Nav1.7, Depression, Epilepsy, FOS, Pain, SCN8A, Ageing, KV7, Food, Neurocrine Biosciences, MDD, Patient, Safety, OLE, Channel modulator, Pharmaceutical industry

VANCOUVER, British Columbia, Jan. 08, 2024 (GLOBE NEWSWIRE) --  Xenon Pharmaceuticals Inc. (Nasdaq:XENE), a neurology-focused biopharmaceutical company, today outlined progress within its pipeline programs and key milestones for 2024.

Key Points: 
  • VANCOUVER, British Columbia, Jan. 08, 2024 (GLOBE NEWSWIRE) --  Xenon Pharmaceuticals Inc. (Nasdaq:XENE), a neurology-focused biopharmaceutical company, today outlined progress within its pipeline programs and key milestones for 2024.
  • Xenon anticipates that patient enrollment in X-TOLE2 will be completed in the second half of 2024.
  • Xenon is actively assessing various clinical and regulatory pathways to support late-stage clinical development of XEN1101 in MDD and expects to initiate the Phase 3 clinical program in 2024.
  • The near-term focus is on development candidates targeting Kv7, Nav1.1 and Nav1.7 where Xenon expects multiple candidates will enter IND-enabling studies in 2024 and 2025.

Cybin Highlights Recent Topline Results and Outlines Key Upcoming Milestones Across its Clinical Development Programs

Retrieved on: 
Thursday, January 4, 2024
Biotechnology, Alternative Medicine, FDA, Health, General Health, Pharmaceutical, Mental Health, Other Science, Research, Science, Clinical Trials, Initiate, NEO, Food, Depression, Selective serotonin reuptake inhibitor, Data analysis, Data, DSM-IV codes, Increment, IM, Pharmacokinetics, MDD, Patient, Safety, Anxiety, Food and Drug Administration, SSRI, DMT, Inc., Pharmaceutical industry

The first quarter of 2024 should be another active and productive period for us, as we advance our clinical programs.

Key Points: 
  • The first quarter of 2024 should be another active and productive period for us, as we advance our clinical programs.
  • For our dDMT programs, we plan to initiate a Phase 2 trial of CYB004 in generalized anxiety disorder (“GAD”),” said Doug Drysdale, Chief Executive Officer of Cybin.
  • “As we look ahead, we see enormous opportunities for progress across our differentiated programs and development pipeline.
  • Upcoming Milestones for dDMT Program:
    Phase 1 topline data for CYB004 expected early Q1 2024.

atai Life Sciences Announces Strategic Investment in Beckley Psytech to Accelerate the Clinical Development of Short-Duration Psychedelics

Retrieved on: 
Thursday, January 4, 2024
Atypical depression, Treatment, Sale, Psilocybin, Depression, Major depressive disorder, Mental health, Webcast, MDD, Patient, TRD, Therapy, Pharmacology, Pharmaceutical industry

This strategic investment and collaboration aims to accelerate the development of Beckley Psytech’s two clinical-stage, patent-protected, short-duration psychedelic candidates, BPL-003 and ELE-101, by adding them to atai’s mental health innovation platform.

Key Points: 
  • This strategic investment and collaboration aims to accelerate the development of Beckley Psytech’s two clinical-stage, patent-protected, short-duration psychedelic candidates, BPL-003 and ELE-101, by adding them to atai’s mental health innovation platform.
  • “This transaction underscores our conviction in the potential of psychedelics as groundbreaking treatments for people living with mental health disorders.
  • atai Life Sciences will host a conference call and live webcast on Thursday January 4, 2024 at 8:00 a.m.
  • The conference call can be accessed on the Investors section of atai Life Sciences’ website under News, Events & Presentations, via the following link: https://ir.atai.life/news-events/events.

ABVC BioPharma and its Subsidiary Receive $460M From AiBtl BioPharma as the First Milestone Payment of Global Licensing Fees

Retrieved on: 
Wednesday, January 3, 2024
Partnership, BioLite, Attention deficit hyperactivity disorder, Ophthalmology, CNS, MDD, ADHD, Pharmaceutical industry

The agreement between the Company and AiBtl placed a value of $460 ($10 per share) on such payment.

Key Points: 
  • The agreement between the Company and AiBtl placed a value of $460 ($10 per share) on such payment.
  • According to the terms of the agreement, AiBtl delivered 46M shares to the Company as the first milestone payment.
  • He continued, "After this licensing payment, AiBtl becomes a subsidiary of ABVC, which holds 57% of the consolidated shares of AiBtl; accordingly, AiBtl is now also considered a related party.
  • “We believe this milestone payment marks the beginning of ABVC's revenue generation through licensing deals and opens new avenues that could potentially increase ABVC's revenue.

Healis Therapeutics Announces Supply Agreement with CKD Bio to develop CKDB-501 for neuropsychiatric indications

Retrieved on: 
Tuesday, January 2, 2024
Partnership, Post-traumatic stress disorder, Mental health, Depression, Research, WHO, Major depressive disorder, Therapy, PTSD, Bangladesh Technical Education Board, World Health Organization, MDD, Patient, Veterans' affairs, CKD

NEWPORT BEACH, Calif., Jan. 02, 2024 (GLOBE NEWSWIRE) -- Healis Therapeutics, a privately held biotechnology company, today announced it has entered into a supply agreement with CKD Bio Corporation (A063160.KS) for CKDB-501, a neuromodulator BoNT/A protein.

Key Points: 
  • NEWPORT BEACH, Calif., Jan. 02, 2024 (GLOBE NEWSWIRE) -- Healis Therapeutics, a privately held biotechnology company, today announced it has entered into a supply agreement with CKD Bio Corporation (A063160.KS) for CKDB-501, a neuromodulator BoNT/A protein.
  • CKD Bio is a subsidiary of Chong Kun Dang group based in Seoul, South Korea.
  • Healis Therapeutics intends to develop CKDB-501 for Major Depressive Disorder (MDD) and Post-Traumatic Stress Disorder (PTSD).
  • “Our collaboration with CKD Bio on this new agreement could one day impact over 42 million Americans” said Sebastian De Beurs, Co-Founder of Healis.

Nexalin Technology Reports Significant Positive Results of Clinical Study Supporting the Therapeutic Benefits of its Gen-2, 15 Milliamp Neurostimulation Device on Treatment-Resistant Depression

Retrieved on: 
Monday, December 18, 2023
Risk, Migraine, Zygomatic bone, Grammatical mood, Forehead, Depression, Capital Medical University, Trial of the century, Clinical trial, Behavior, Appetite, Sleep, MDD, Patient, TRD, Pharmaceutical industry

The published results of the study concluded that repeated treatment with Nexalin’s neurostimulation device suggests an acute effect in reducing depressive symptoms in patients with TRD.

Key Points: 
  • The published results of the study concluded that repeated treatment with Nexalin’s neurostimulation device suggests an acute effect in reducing depressive symptoms in patients with TRD.
  • Major depressive disorder (MDD), also known as clinical depression, is a mental health condition that affects mood, behavior, appetite, and sleep.
  • We believe the data provides further evidence of the significant impact of our non-invasive, drug-free device on improving mental healthcare outcomes among patients affected with TRD.
  • No significant adverse effects were reported, which is especially noteworthy given the growing number of patients seeking non-pharmacological treatment options.

Axsome Therapeutics Presents New Data and Post-Hoc Analyses of Auvelity® in Patients with Major Depressive Disorder at the American College of Neuropsychopharmacology (ACNP) 2023 Annual Meeting

Retrieved on: 
Monday, December 11, 2023
Psychiatry, Quality of life, Medication discontinuation, GEMINI, Evolve, Depression, University, DSM-IV codes, Therapy, Drug, Quality, FRCPC, Annual general meeting, CNS, American College, University of Toronto, EVOLVE, Central nervous system, MDD, Anxiety, Grammatical mood, ASCEND, Pharmaceutical industry

NEW YORK, Dec. 11, 2023 (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 new data that treatment with Auvelity® (dextromethorphan-bupropion) was associated with improvement in quality of life outcomes in broad populations of depression patients in the EVOLVE open-label trial in major depressive disorder (MDD). These new data were presented at the American College of Neuropsychopharmacology (ACNP) 2023 Annual Meeting, held in Tampa, Florida, from Dec. 3-6, 2023.

Key Points: 
  • New data on Auvelity’s impact on quality of life, measured by the Q-LES-Q-SF, in patients who had received at least one prior treatment during their current depressive episode
    NEW YORK, Dec. 11, 2023 (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 new data that treatment with Auvelity® (dextromethorphan-bupropion) was associated with improvement in quality of life outcomes in broad populations of depression patients in the EVOLVE open-label trial in major depressive disorder (MDD).
  • These new data were presented at the American College of Neuropsychopharmacology (ACNP) 2023 Annual Meeting, held in Tampa, Florida, from Dec. 3-6, 2023.
  • An evaluation of interest and activity levels of individuals with MDD following treatment with Auvelity in a pooled post-hoc analysis of the placebo-controlled GEMINI and active-controlled ASCEND studies, and an analysis of potential withdrawal symptoms following discontinuation of Auvelity treatment in the GEMINI trial were also presented.
  • “Depression exacts an extraordinary impact on affected individuals especially by impairing enjoyment in activities and role function,” said Roger McIntyre, MD, FRCPC, Professor of Psychiatry and Pharmacology at the University of Toronto and lead author.

Axsome Therapeutics Hosts Solriamfetol Virtual Investor Event with Expert Thought Leaders Today

Retrieved on: 
Thursday, December 7, 2023
Sleep medicine, Psychiatry, Attention deficit hyperactivity disorder, Obstructive sleep apnea, Eastern Time Zone, Division, Binge eating disorder, TAAR1, Psychopharmacology, BED, SHARP, Medical school, DSM-IV codes, MD, Doctor of Philosophy, Research, Therapy, University, HOPE, Associate, EDS, CNS, Narcolepsy, OSA, Webcast, Central nervous system, MDD, Patient, ADHD, Harvard Medical School, Dopamine, SWD

At the event, invited physician thought leaders will discuss current and potential future indications.

Key Points: 
  • At the event, invited physician thought leaders will discuss current and potential future indications.
  • The Axsome senior leadership team will provide an overview of clinical development plans.
  • Expert thought leaders presenting at the event include:
    Craig Chepke, MD, Medical Director of Excel Psychiatric Associates in Huntersville, N.C. and Adjunct Associate Professor of Psychiatry for Atrium Health.
  • A replay of the webcast will be available for approximately 30 days following the live event.