Major depressive disorder

Healis Therapeutics announces collaboration with Massachusetts General Hospital (MGH) and affiliates of Harvard Medical School to advance clinical-stage neuroscience research

Retrieved on: 
Tuesday, March 26, 2024
MGH, Harvard Medical School, Public health, Mass General Brigham, Massachusetts General Hospital, MDD, Patient, Public, Roche, Research, Merck, Social anxiety disorder, DSM-IV codes, Bristol Myers Squibb, Clinical trial, Neuropsychiatry, HMS, World Health Organization, Therapy, Hospital, Safety, WHO, SAD, Major depressive disorder, PTSD, Mass, Pharmaceutical industry

Healis Therapeutics is pleased to announce that it has entered a clinical collaboration with Massachusetts General Hospital (MGH), a founding member of the Mass General Brigham health system, and affiliates of Harvard Medical School (HMS).

Key Points: 
  • Healis Therapeutics is pleased to announce that it has entered a clinical collaboration with Massachusetts General Hospital (MGH), a founding member of the Mass General Brigham health system, and affiliates of Harvard Medical School (HMS).
  • “We continue to observe very significant need in the neuropsychiatric patient population,” said Dr. Eric Finzi, Co-Founder of Healis Therapeutics.
  • “MDD remains a public health challenge around the world,” said Erik Van Widenfelt, Head of Clinical Trials at Healis Therapeutics.
  • General Hospital (MGH) and Harvard Medical School,” said Sebastian De Beurs, Co-Founder of Healis Therapeutics.

PureTech Launches Seaport Therapeutics with $100 Million Oversubscribed Series A and Announces Management Transitions

Retrieved on: 
Tuesday, April 9, 2024
Biotechnology, General Health, Health, Pharmaceutical, Clinical Trials, Depression, Eli Lilly, Major depressive disorder, Patient, Bristol Myers Squibb, PureTech Health, PRTC, Therapy, Creativity, Disorder, General counsel, CNS, Life, DSM-IV codes, Pleasure, Pharmacokinetics, Interim, Third Rock Ventures, U.S. FDA, Schizophrenia, KarXT, Teva Pharmaceuticals, ARCH Venture Partners, Merck, Anxiety, Merck & Co., Research and development, FDA, Lymphatic system, Hepatotoxicity, Sirna Therapeutics, Generalized anxiety disorder, Growth, Neuropsychiatry, Partner, Multimedia, Eli Lilly and Company, Probability, Liver, Medicine, Pharmaceutical industry

Following the Series A financing, PureTech will hold equity ownership in Seaport of 61.5 percent on a diluted basis.

Key Points: 
  • Following the Series A financing, PureTech will hold equity ownership in Seaport of 61.5 percent on a diluted basis.
  • Under its license agreement with Karuna, PureTech retains the right to receive milestone payments upon the achievement of certain regulatory approvals.
  • Eric Elenko, Ph.D., a PureTech co-founder and current Chief Innovation Officer, has been promoted to the role of President of PureTech.
  • Daphne Zohar, the Chief Executive Officer of Seaport, is the founder and former CEO of PureTech Health where she also co-founded Karuna Therapeutics.

Seaport Therapeutics Launches with $100 Million Oversubscribed Series A Financing Round to Advance Novel Neuropsychiatric Medicines

Retrieved on: 
Tuesday, April 9, 2024
Mental Health, Health, Neurology, General Health, Pharmaceutical, Biotechnology, Generalized anxiety disorder, Depression, Eli Lilly, U.S. FDA, Schizophrenia, KarXT, Major depressive disorder, ARCH Venture Partners, Patient, CNS, Anxiety, Bristol Myers Squibb, PureTech Health, DSM-IV codes, Pleasure, Neuropsychiatry, Research and development, Therapy, Pharmacokinetics, Partner, Disorder, Third Rock Ventures, Probability, FDA, Lymphatic system, Hepatotoxicity, Liver, Medicine, Pharmaceutical industry

Seaport Therapeutics , a clinical-stage biopharmaceutical company that is charting a proven path in neuropsychiatry, today announced the closing of a $100 million oversubscribed Series A financing round.

Key Points: 
  • Seaport Therapeutics , a clinical-stage biopharmaceutical company that is charting a proven path in neuropsychiatry, today announced the closing of a $100 million oversubscribed Series A financing round.
  • The round was co-led by ARCH Venture Partners and Sofinnova Investments along with Third Rock Ventures and Seaport founder PureTech Health.
  • Seaport is advancing a clinical-stage pipeline of novel neuropsychiatric medicines powered by its proprietary Glyph™ Technology Platform, which leverages the lymphatic system to create new medicines building on clinically validated mechanisms.
  • I am eager to support Seaport as an investor and board member as the team continues to advance its clinical-stage pipeline of novel therapeutics.”

Cybin Announces Positive End-of-Phase 2 Meeting with FDA for CYB003 in Major Depressive Disorder and Phase 3 Program Design

Retrieved on: 
Thursday, March 14, 2024
Mental Health, Finance, FDA, Clinical Trials, Professional Services, Biotechnology, Alternative Medicine, Health, Pharmaceutical, Depression, Week, DEA, BTD, Inc., MDD, Patient, Accelerated approval (FDA), DSM-IV codes, Suicidal ideation, Behavior, Priority review, Drug development, Major depressive disorder, Pharmaceutical industry

The Company has received minutes from its End-of-Phase-2 meeting with the FDA and reached alignment on its Phase 3 program design.

Key Points: 
  • The Company has received minutes from its End-of-Phase-2 meeting with the FDA and reached alignment on its Phase 3 program design.
  • The Company intends to commence enrollment for the multinational, multisite Phase 3 program in mid-year 2024.
  • The Company has engaged Worldwide Clinical Trials (“Worldwide”), a global, full-service contract research organization with deep expertise managing clinical trials for mental health conditions, including major depressive disorder.
  • Having aligned on key features of the pivotal program, we look forward to initiating a multisite, multinational Phase 3 program around mid-year,” said Doug Drysdale, Chief Executive Officer of Cybin.

PsyRx Advances Clinical Trial Exploration with Successful Completion of Toxicological Safety Study in Rats

Retrieved on: 
Monday, March 25, 2024
Pharmacy, MDD, SSRI, Human, Patient, Cyclothymia, Hope, Research, Animal, Major depressive disorder, TEL, Clinical trial, Ibogaine, Safety, Pharmaceutical industry

TEL AVIV, Israel, March 25, 2024 /PRNewswire/ -- PsyRx, a leading innovator in pharmaceutical research, is pleased to announce the successful conclusion of the live phase of a toxicological safety study involving the combined treatment of SSRI plus ibogaine.

Key Points: 
  • TEL AVIV, Israel, March 25, 2024 /PRNewswire/ -- PsyRx, a leading innovator in pharmaceutical research, is pleased to announce the successful conclusion of the live phase of a toxicological safety study involving the combined treatment of SSRI plus ibogaine.
  • This groundbreaking study is a pivotal step in the company's ongoing evaluations for conducting a clinical trial in humans, specifically focusing on patients suffering from Major Depressive Disorders (MDD).
  • During the 14 consecutive treatment days, the study examined the safety of administering the combined treatment at three different dose levels—low, medium, and high.
  • The successful completion of this toxicological safety study marks a significant achievement in the pursuit of improving the lives of individuals affected by MDD.

Healis Therapeutics' asset CKDB-501A shares Phase III topline results for glabellar injections from CKD Bio in South Korea

Retrieved on: 
Tuesday, February 27, 2024
Biotechnology, Neuropsychiatry, AbbVie, Post-traumatic stress disorder, Amygdala, CKD, Safety, World Health Organization, Therapy, CNS, Patient, Major depressive disorder, PTSD, DSM-IV codes, MDD, WHO, Partnership, Pharmaceutical industry

The study results demonstrated that CKDB-501A is non-inferior compared to the active-controlled BOTOX® by AbbVie (NYSE: ABBV) in improving moderate-to-severe glabellar lines.

Key Points: 
  • The study results demonstrated that CKDB-501A is non-inferior compared to the active-controlled BOTOX® by AbbVie (NYSE: ABBV) in improving moderate-to-severe glabellar lines.
  • A randomized, double-blind, active-controlled, multi-center Phase 3 trial to investigate the efficacy and safety of CKDB-501A in subjects with moderate-to-severe glabellar lines was completed in South Korea on November 20, 2023 (NCT05804656).
  • “This is clinically promising to see Healis’ lead protein, CKDB-501A, pass safety and efficacy in South Korea,” said Dr. Eric Finzi, Co-Founder of Healis Therapeutics.
  • Healis Therapeutics announced a strategic partnership with CKD Bio in 2024 to develop CKDB-501A for CNS indications.

Castle Biosciences Reports Fourth Quarter and Full-Year 2023 Results

Retrieved on: 
Wednesday, February 28, 2024
Mental Health, Research, Clinical Trials, Biotechnology, Other Health, Health, Pharmaceutical, Science, Oncology, Well, Neoplasm, Psoriasis, DecisionDx-UM, Investment, News, Growth, Table, Uveal melanoma, Epidemiology, SCC, Webcast, Diagnosis, Mortality, Woman, Melanoma, Cohort (statistics), Recurrence, BWH, Overalls, Radiation, Metastasis, Mycosis fungoides, GAAP, Journal, Net, Depreciation, PSO, Major depressive disorder, Randomized controlled trial, Atopic dermatitis, Adjustment, Practitioner, ART, Castle, National Comprehensive Cancer Network, Survival, MDD, Workflow, Acquisition, MF, Risk, Medicare, NCCN, Patient, Pharmaceutical industry

Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, today announced its financial results for the fourth quarter and year ended Dec. 31, 2023.

Key Points: 
  • Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, today announced its financial results for the fourth quarter and year ended Dec. 31, 2023.
  • DecisionDx-SCC test reports delivered in the quarter were 3,530, compared to 1,845 in the fourth quarter of 2022, an increase of 91%.
  • DecisionDx-UM test reports delivered in the quarter were 405, compared to 432 in the fourth quarter of 2022, a decrease of 6%.
  • Castle Biosciences will hold a conference call on Wednesday, Feb. 28, 2024, at 4:30 p.m. Eastern time to discuss its fourth quarter and full-year 2023 results and provide a corporate update.

Psychedelics set to be the revolutionary treatments in pscyhiatry- Thelansis Knowledge Partners

Retrieved on: 
Thursday, February 22, 2024
Knowledge, DSM-IV codes, Esketamine, TRD, Major depressive disorder, Drug development, TAS, USFDA, Psilocybin, MDMA, Psychiatry, CNS, Patient, Acute stress disorder, PTSD, Polypharmacy, Psychotherapy, MDD, KOL, Research, Central nervous system disease, Pharmaceutical industry

Availability of psychedelic(s) with few administrations in a year and offering high remission rate could change the treatment pathway for these patients."

Key Points: 
  • Availability of psychedelic(s) with few administrations in a year and offering high remission rate could change the treatment pathway for these patients."
  • According to an interviewed U.S.-based neurologist by Thelansis – "We desperately need disease-modifying treatments for many neurodegenerative conditions.
  • As psychedelics would be beneficial for treatment-nonresponders or severe patients, the commercial opportunities are multiple for in-pipeline psychedelic therapies.
  • What is the probable opportunity for Psychedelics (e.g., psilocybin, MDMA) to address the unmet needs of other TAs?

Psychedelics set to be the revolutionary treatments in pscyhiatry - Thelansis Knowledge Partners

Retrieved on: 
Thursday, February 22, 2024
Knowledge, DSM-IV codes, Esketamine, TRD, Major depressive disorder, Drug development, TAS, USFDA, Psilocybin, MDMA, Psychiatry, CNS, Patient, Acute stress disorder, PTSD, Polypharmacy, Psychotherapy, MDD, KOL, Research, Central nervous system disease, Pharmaceutical industry

Availability of psychedelic(s) with few administrations in a year and offering high remission rate could change the treatment pathway for these patients."

Key Points: 
  • Availability of psychedelic(s) with few administrations in a year and offering high remission rate could change the treatment pathway for these patients."
  • According to an interviewed U.S.-based neurologist by Thelansis – "We desperately need disease-modifying treatments for many neurodegenerative conditions.
  • As psychedelics would be beneficial for treatment-nonresponders or severe patients, the commercial opportunities are multiple for in-pipeline psychedelic therapies.
  • What is the probable opportunity for Psychedelics (e.g., psilocybin, MDMA) to address the unmet needs of other TAs?

MycoMeditations Surveys Show Lasting Benefits of Psilocybin Therapy for Major Depression and Anxiety Disorders

Retrieved on: 
Tuesday, February 20, 2024
Psilocybin, GAD-7, Social anxiety, SAD, Mental health, Multimedia, PHQ-9, Treatment, Post-traumatic stress disorder, GAD, Anxiety, Generalized anxiety disorder, Social anxiety disorder, Major depressive disorder, Clinical trial, PTSD, MDD, Comment, Research

TREASURE BEACH, Jamaica, Feb. 20, 2024 /PRNewswire-PRWeb/ -- MycoMeditations, a pioneer in legal psilocybin-assisted therapy retreats, today announced the results of two years of longitudinal (long-term) client surveys exploring the impact of its psilocybin retreats on individuals suffering with Major Depressive Disorder (MDD), Generalized Anxiety Disorder (GAD), and Social Anxiety Disorder (SAD). The findings complement MycoMeditations' previously released surveys focused on Post-Traumatic Stress Disorder (PTSD).

Key Points: 
  • The findings complement MycoMeditations' previously released surveys focused on Post-Traumatic Stress Disorder (PTSD).
  • MycoMeditations employed the PHQ-9, GAD-7, and SM-SAD-Adult questionnaires to measure self-reported symptom severity and long-term outcomes across MDD, GAD, and SAD, respectively.
  • Clinically significant improvements were maintained for one year following retreat for each Major Depressive Disorder, Generalized Anxiety, and Social Anxiety, suggesting possible long-term efficacy of psilocybin-assisted therapy.
  • The data suggests the viability of multiple psilocybin treatments in a short period of time when coupled with therapy, as MycoMeditations retreats are 7-nights with 3 psilocybin sessions on alternating days.