MDD

Intra-Cellular Therapies Highlights Data Presentations at the American College of Neuropsychopharmacology Annual Meeting

Retrieved on: 
Tuesday, December 5, 2023
Neuropsychiatry, Treatment, DSM-IV codes, IND, Grammatical mood, Depression, Prevalence, Literature, Mouse, Human, DSM-5, Cyclothymia, MADRS, Anxiety, Prefrontal cortex, Hallucination, Annual general meeting, Clinical Global Impression, CNS, Social, Poster, American College, Restless, Central nervous system, MDD, Patient, Therapy, Lumateperone, Pharmaceutical industry

NEW YORK, Dec. 05, 2023 (GLOBE NEWSWIRE) -- Intra-Cellular Therapies, Inc. (Nasdaq: ITCI), a biopharmaceutical company focused on the development and commercialization of therapeutics for central nervous system (CNS) disorders, today announced data presentations at the American College of Neuropsychopharmacology (ACNP) 62nd Annual Meeting.

Key Points: 
  • Company presents preclinical data on ITI-1549, our lead product candidate in our non-hallucinogenic psychedelics program in mood disorders and other psychiatric disorders.
  • NEW YORK, Dec. 05, 2023 (GLOBE NEWSWIRE) -- Intra-Cellular Therapies, Inc. (Nasdaq: ITCI), a biopharmaceutical company focused on the development and commercialization of therapeutics for central nervous system (CNS) disorders, today announced data presentations at the American College of Neuropsychopharmacology (ACNP) 62nd Annual Meeting.
  • Inner tension is an item within the MADRS which is often used as a surrogate marker for anxiety.
  • The data presented in this poster represent further analyses from Study 403.

NeuroStar TMS Receives Expanded Regulatory Approval in Japan

Retrieved on: 
Monday, December 4, 2023
Neuronetics, Marketing, Quality of life, Partnership, Depression, Medication, TMS, MDSAP, DSM-IV codes, Health, MDD, Patient, Transcranial magnetic stimulation, STIM, Dash, PMDA

The features covered in this approval include the NeuroStar 3.7 platform, MT Cap , D-Tect ™ MT Accessory, and the Dash treatment protocol.

Key Points: 
  • The features covered in this approval include the NeuroStar 3.7 platform, MT Cap , D-Tect ™ MT Accessory, and the Dash treatment protocol.
  • The Dash treatment protocol reduces the daily TMS treatment time from 38 minutes to under 19 minutes.
  • NeuroStar TMS Therapy aims to fill this unmet need through its exclusive distribution partnership with Teijin Pharma Limited.
  • NeuroStar is advancing its global strategy and strengthening its global presence with recent announcements of regulatory approval in South Korea , as well as EU-MDR and MDSAP certifications.

Xenon Pharmaceuticals Provides Updates on Neurology Pipeline Programs at the Annual Meeting of the American Epilepsy Society (AES 2023)

Retrieved on: 
Saturday, December 2, 2023
Xenon, Quality of life, Skill, SCN1A, Convention, Aes, Efficacy, Depression, Epilepsy, AES, Poster, American Epilepsy Society, ASMS, DSM-IV codes, SFG, Seizure, MPC, Dravet syndrome, Anxiety, Annual general meeting, Neurology, Food, Safety, MDD, Patient, Orange County Convention Center, OLE, Pharmaceutical industry

VANCOUVER, British Columbia, Dec. 02, 2023 (GLOBE NEWSWIRE) -- Xenon Pharmaceuticals Inc. (Nasdaq:XENE), a neurology-focused biopharmaceutical company, today announced it will provide updates on its neurology programs at the Annual Meeting of the American Epilepsy Society (AES 2023).

Key Points: 
  • VANCOUVER, British Columbia, Dec. 02, 2023 (GLOBE NEWSWIRE) -- Xenon Pharmaceuticals Inc. (Nasdaq:XENE), a neurology-focused biopharmaceutical company, today announced it will provide updates on its neurology programs at the Annual Meeting of the American Epilepsy Society (AES 2023).
  • Importantly, we are looking forward to presenting new interim data from our ongoing open-label extension study from our Phase 2b X-TOLE trial.
  • The exhibit will also feature the topline results from the Phase 2 proof-of-concept X-NOVA clinical trial in major depressive disorder.
  • Posters will be added to the Xenon website consistent with AES 2023 conference guidelines.

Xenon Pharmaceuticals Announces Topline Results from Phase 2 Proof-of-Concept X-NOVA Clinical Trial of XEN1101 in Major Depressive Disorder (MDD)

Retrieved on: 
Monday, November 27, 2023
Xenon, Șaeș, Physician, Anhedonia, Depression, Epilepsy, American Epilepsy Society, DSM-IV codes, Incidence, SAE, Seizure, Clinical Global Impression, Neurology, Weight gain, MDD, Patient, Safety, Pharmaceutical industry

The primary endpoint of the study was a change in the Montgomery-Åsberg Depression Rating Scale, or MADRS, at week 6.

Key Points: 
  • The primary endpoint of the study was a change in the Montgomery-Åsberg Depression Rating Scale, or MADRS, at week 6.
  • The mean reduction was 13.90 in the placebo group, 15.61 in the XEN1101 10 mg group and 16.94 in the XEN1101 20 mg group.
  • A clear dose response and a clinically meaningful, but not statistically significant, 3.04 difference between placebo and the XEN1101 20 mg group (p=0.135) was observed.
  • We are excited to share the data generated in X-NOVA with epileptologists and neurologists at the upcoming American Epilepsy Society meeting in December.”

ABVC BioPharma Enters Definitive Agreement with Licensing Income Worth $467M and Royalties Up to $200M

Retrieved on: 
Thursday, November 16, 2023
CNS, Ophthalmology, Attention deficit hyperactivity disorder, ADHD, Licensed production, IPO, Good agricultural practice, Partnership, Therapure BioPharma Inc, BioLite, Family, Drug development, MDD, Pharmaceutical industry, Polaris

The agreement has the potential of licensing income worth $467M and royalties up to $200M.

Key Points: 
  • The agreement has the potential of licensing income worth $467M and royalties up to $200M.
  • The Licensed Products for MDD and ADHD, owned by ABVC and its subsidiary BioLite, Inc., were valued at $667M by a third-party evaluation.
  • ABVC and AiBtl are determined to work to strengthen their new drug development and business collaboration.
  • "With ABVC as one of our major shareholders, holding 57% consolidated shares of AiBtl, we are proud to join the family of ABVC BioPharma.

ABVC BioPharma Reports Third Quarter 2023 Financial and Operational Results

Retrieved on: 
Wednesday, November 15, 2023
CNS, Sale, CSMC, Retina, Patient, Triple-negative breast cancer, Attention deficit hyperactivity disorder, Cayman, Investigational New Drug, US FDA, Licensed production, Cancer, Power purchase agreement, SIV, Security (finance), Toxicity, Plasma protein binding, Syndrome, IND, Surgeon, TGA, BioLite, ADHD, Taiwan Stock Exchange, Sales management, Hydrogel, MDD, Pancreatic cancer, Depression, GMP, Good manufacturing practice, Bank statement, UCSF, MDS, University, Partnership, Phase, Drug development, Research, ANDA, Warrant, FDA, Dietary supplement, West Pharmaceutical Services, Share (finance), Pharmaceutical industry, Cryptocurrency, Qiu Zhonghui

FREMONT, CA, Nov. 15, 2023 (GLOBE NEWSWIRE) -- via NewMediaWire – ABVC BioPharma, Inc. (NASDAQ: ABVC) ("Company"): Today, a biotechnology company specializing in botanically based solutions that deliver high efficacy and low toxicity to improve health outcomes announced its financial and operating results for the third quarter of 2023.

Key Points: 
  • FREMONT, CA, Nov. 15, 2023 (GLOBE NEWSWIRE) -- via NewMediaWire – ABVC BioPharma, Inc. (NASDAQ: ABVC) ("Company"): Today, a biotechnology company specializing in botanically based solutions that deliver high efficacy and low toxicity to improve health outcomes announced its financial and operating results for the third quarter of 2023.
  • During July 2023, the warrant exercise price was reset to $3.5 under the issuance of common stock about securities purchase agreement on July 2023.
  • During the third quarter of 2023, the Company issued to Zhonghui an aggregate of 370,000 shares of the Company's common stock at a per-share price of $20.
  • "We are delighted with our remarkable accomplishments and meaningful progress in 2023, and look forward to upcoming reports to end 2023 on a positive note," said Uttam Patil, Ph.D., Chief Executive Officer of ABVC BioPharma.

Alzamend Neuro Receives FDA “Study May Proceed” Notification for a Phase IIA Clinical Trial of AL001, a Next‑Generation Lithium Therapeutic Drug Candidate, in Post-Traumatic Stress Disorder Patients

Retrieved on: 
Monday, December 11, 2023
Biotechnology, Mental Health, Health, Pharmaceutical, Clinical Trials, Food, TDM, Post-traumatic stress disorder, Clinical research associate, Patient, IIA, Multimedia, FDA, Bipolar disorder, PTSD, Lithium, MDD

View the full release here: https://www.businesswire.com/news/home/20231211519845/en/

Key Points: 
  • View the full release here: https://www.businesswire.com/news/home/20231211519845/en/
    “We are grateful to receive this timely, favorable response from the FDA to initiate our first Phase IIA clinical study of AL001 for PTSD.
  • Although lithium does not have an FDA-approved indication for PTSD, it has been prescribed off-label for this purpose for decades,” said Stephan Jackman, Chief Executive Officer of Alzamend.
  • We are advancing the process and expect that the first patient will be dosed in the first quarter of 2024.
  • We have now received ‘Study May Proceed’ letters from the FDA during the last three months for Phase IIA clinical studies of AL001 for treatment of patients with BD, MDD and PTSD.”

Alto Neuroscience Announces Data from Presentations at the 62nd Annual Meeting of the American College of Neuropsychopharmacology

Retrieved on: 
Thursday, December 7, 2023
Mental Health, Technology, Neurology, Clinical Trials, Health Technology, Biotechnology, General Health, Pharmaceutical, Health, Artificial Intelligence, Brain, Schizophrenia, Depression, Electroencephalography, Safety, Deficit spending, Dean (education), Grammatical mood, PD, Clinical trial, Data, Patient, American College, American College of Neuropsychopharmacology, Cross, DSM-IV codes, MADRS, Cognition, Cyclothymia, MD, Harvard Medical School, Translational research, Massachusetts General Hospital, ERP, Neuroscience, EEG, Mental health, Biomarker, MDD, Medical imaging, Phosphorus, Medical device, Pharmaceutical industry, Alto

Alto Neuroscience, Inc. today announced details from three presentations on clinical development programs presented at the 62nd annual meeting of the American College of Neuropsychopharmacology (ACNP) that took place in Tampa, Florida, from December 3-6, 2023.

Key Points: 
  • Alto Neuroscience, Inc. today announced details from three presentations on clinical development programs presented at the 62nd annual meeting of the American College of Neuropsychopharmacology (ACNP) that took place in Tampa, Florida, from December 3-6, 2023.
  • Alto’s data demonstrate advancements in biomarker identification for precision psychiatry and the potential to improve upon the trial-and-error approach to mental health treatment.
  • The company’s AI-enabled Precision Psychiatry Platform™ is designed to predict clinical response and match each patient to the right Alto product candidate through identifying, and prospectively replicating, brain biomarkers by analyzing data generated from EEG activity, neurocognitive task performance, wearable devices, and other measures.
  • Additionally, Alto is advancing ALTO-101 into a Phase 2 proof of concept study in patients with cognitive impairment associated with schizophrenia, with topline data expected in 2025.

Cybin Announces Grant of Additional U.S. Patent in Support of its CYB003 Deuterated Psilocybin Analog Program

Retrieved on: 
Wednesday, December 6, 2023
Alternative Medicine, Professional Services, Patent Law, Mental Health, Health, Pharmaceutical, Biotechnology, Patent, NEO, Safety, NYSE, Depression, Patient, Inc., MDD, Pharmaceutical industry

Cybin Inc. (NYSE American:CYBN) (NEO:CYBN) (“Cybin” or the “Company”), a clinical-stage biopharmaceutical company committed to revolutionizing mental healthcare by developing new and innovative next-generation psychedelic-based treatment options, today announced that the United States Patent and Trademark Office (“USPTO”) has granted U.S. patent 11,834,410 in support of its CYB003 program.

Key Points: 
  • Cybin Inc. (NYSE American:CYBN) (NEO:CYBN) (“Cybin” or the “Company”), a clinical-stage biopharmaceutical company committed to revolutionizing mental healthcare by developing new and innovative next-generation psychedelic-based treatment options, today announced that the United States Patent and Trademark Office (“USPTO”) has granted U.S. patent 11,834,410 in support of its CYB003 program.
  • The patent, which is expected to provide exclusivity until at least 2041, includes composition of matter claims to pharmaceutical compositions within the Company’s proprietary deuterated psilocybin analog program, CYB003, as well as claims directed toward the therapeutic treatment of major depressive disorder (“MDD”), treatment-resistant depression, and alcohol use disorder.
  • “Securing robust patent protection for our proprietary products is a top priority, and we are pleased to announce this additional U.S. patent supporting our CYB003 program,” said Doug Drysdale, Chief Executive Officer of Cybin.
  • “Last week, we shared positive Phase 2 topline safety and efficacy data for CYB003 in MDD.

Cybin Announces Four Poster Presentations at the 2023 American College of Neuropsychopharmacology Annual Meeting Including CYB003 Phase 2 Topline Results

Retrieved on: 
Tuesday, December 5, 2023
Alternative Medicine, Mental Health, Health, Neurology, Clinical Trials, Pharmaceutical, Biotechnology, Psilocybin, Depression, Safety, NYSE, Efficacy, DMT, DSM-IV codes, NEO, American College, American College of Neuropsychopharmacology, Pharmacology, MBBS, Abstract, Deuterium, DNB, Inc., MDD, Pharmaceutical industry, Patient

“In our study of CYB003 for MDD, we observed rapid and large improvements in symptoms of depression after single doses, with a clear incremental benefit of a second dose.

Key Points: 
  • “In our study of CYB003 for MDD, we observed rapid and large improvements in symptoms of depression after single doses, with a clear incremental benefit of a second dose.
  • “As evidenced in each of these presentations, our deuterated programs – psilocybin analog (CYB003) and DMT compounds (CYB004 and SPL028) – are producing highly encouraging results.
  • This is a transformational time for Cybin, with several upcoming value-driving catalysts as we advance our clinical programs.
  • Following on from our recently announced Phase 2 topline efficacy data for CYB003, we expect to have Phase 1 dosing, PK/PD, and safety data for CYB004 and intramuscular dosing data for SPL028 around year end 2023.