Lennox–Gastaut syndrome

Avicanna Reports Full Year 2023 Audited Financial Results 

Retrieved on: 
Tuesday, April 2, 2024
Cream, Cannabidiol, Cannabinoid, Dravet syndrome, Brazilian Health Regulatory Agency, Interest, Medical cannabis, Seizure, Business, Lennox–Gastaut syndrome, Patient, Pharmacy, Active ingredient, Research, Acquisition, RDC, Ultra, Stock, CBD, Insurance, Health Canada, Bank statement, GMP, Dermatology, TSX, Therapy, Pharmaceutical industry

TORONTO, April 02, 2024 (GLOBE NEWSWIRE) -- Avicanna Inc. (“Avicanna” or the “Company) (TSX: AVCN) (OTCQX: AVCNF) (FSE: 0NN) a biopharmaceutical company focused on the development, manufacturing, and commercialization of plant-derived cannabinoid-based products is pleased to announce year end 2023 results and audited financial statements.

Key Points: 
  • TORONTO, April 02, 2024 (GLOBE NEWSWIRE) -- Avicanna Inc. (“Avicanna” or the “Company) (TSX: AVCN) (OTCQX: AVCNF) (FSE: 0NN) a biopharmaceutical company focused on the development, manufacturing, and commercialization of plant-derived cannabinoid-based products is pleased to announce year end 2023 results and audited financial statements.
  • Cash used in operations of $1.38 million; an 81% reduction compared to $7.4 million in 2022.
  • “2023 was a tremendous year for Avicanna where we solidified of our leadership position in the Canadian medical cannabis sector through our proprietary products and the launch of MyMedi.ca.
  • We have successfully demonstrated the scalability of our revenues and made significant improvements in our fundamentals while advancing all our business pillars.

Avicanna Announces the Canadian Launch of 10% CBD (THC Free) Proprietary Formulation

Retrieved on: 
Wednesday, March 27, 2024
Cannabinoid, Absorption, Dravet syndrome, Seizure, Lennox–Gastaut syndrome, Patient, Research, CBD, Health Canada, TSX, THC, Plasma protein binding, RHO

TORONTO, March 27, 2024 (GLOBE NEWSWIRE) -- Avicanna Inc. (“Avicanna” or the “Company) (TSX: AVCN) (OTCQX: AVCNF) (FSE: 0NN) a biopharmaceutical company focused on the development, manufacturing, and commercialization of plant-derived cannabinoid-based products is pleased to announce the launch of RHO Phyto Micro Drop 100, a 10% CBD (THC free), proprietary oral formulation in Canada. RHO Phyto Micro Drop 100, is designed to deliver enhanced absorption of cannabinoids through an inverted emulsion technology. RHO Phyto Micro Drop 100 will be available to Canadian patients with medical authorization exclusively at the MyMedi.ca medical cannabis care platform.

Key Points: 
  • TORONTO, March 27, 2024 (GLOBE NEWSWIRE) -- Avicanna Inc. (“Avicanna” or the “Company) (TSX: AVCN) (OTCQX: AVCNF) (FSE: 0NN) a biopharmaceutical company focused on the development, manufacturing, and commercialization of plant-derived cannabinoid-based products is pleased to announce the launch of RHO Phyto Micro Drop 100, a 10% CBD (THC free), proprietary oral formulation in Canada.
  • RHO Phyto Micro Drop 100, is designed to deliver enhanced absorption of cannabinoids through an inverted emulsion technology.
  • RHO Phyto Micro Drop 100 will be available to Canadian patients with medical authorization exclusively at the MyMedi.ca medical cannabis care platform.
  • RHO Phyto Micro Drop 100 contains the same proprietary oral formulation as the product Trunerox™.

Takeda Announces Positive Topline Results from Phase 2 Study Evaluating Mezagitamab (TAK-079), a Potential Best-in-Class Anti-CD38 Monoclonal Antibody, for Primary Immune Thrombocytopenia

Retrieved on: 
Wednesday, March 13, 2024
Neurology, Biotechnology, Pharmaceutical, Oncology, General Health, Health, FDA, Clinical Trials, Fast track (FDA), Psoriasis, Cell, Disease, Risk, Patient, Megakaryocyte, Immunoglobulin G, ITP, B cell, Quality of life, Platelet, Autoantibody, Gastrointestinal tract, CD38, Bleeding, Safety, Dravet syndrome, Blood, Lennox–Gastaut syndrome, Fatigue, Fiscal, Food, Autoimmune disease, Pharmaceutical industry

Takeda ( TSE:4502/NYSE:TAK ) today announced positive topline results from a Phase 2, randomized, double-blind, placebo-controlled study evaluating the safety, tolerability and efficacy of mezagitamab (TAK-079) in patients with persistent or chronic primary immune thrombocytopenia (ITP).

Key Points: 
  • Takeda ( TSE:4502/NYSE:TAK ) today announced positive topline results from a Phase 2, randomized, double-blind, placebo-controlled study evaluating the safety, tolerability and efficacy of mezagitamab (TAK-079) in patients with persistent or chronic primary immune thrombocytopenia (ITP).
  • An interim analysis of the ongoing Phase 2 study demonstrated positive safety and efficacy results.
  • Based on these positive results, and following consultation with global health authorities, Takeda plans to initiate a global Phase 3 trial of mezagitamab in ITP in fiscal year 2024.
  • Results from the Phase 2 trial have no impact on the full year consolidated reported forecast for the fiscal year ending March 31, 2024 (Fiscal Year 2023).

Ovid Therapeutics Reports Business Updates, Fourth Quarter and Full Year 2023 Financial Results

Retrieved on: 
Friday, March 8, 2024
Graviton, Epilepsy, Pharmacy technician, CCM, Research, Transcranial magnetic stimulation, DS, Neuron, Vigabatrin, LGS, Psychosis, Biomarker, Element, Ligand Pharmaceuticals, Lennox–Gastaut syndrome, Patient, Acceleration, Medicine, Status epilepticus, Dravet syndrome, ROCK2, KCC2, Hemangioma, IND, Seizure, Pharmaceutical industry

In addition, Takeda is expected to read out results from two pivotal Phase 3 studies evaluating soticlestat.

Key Points: 
  • In addition, Takeda is expected to read out results from two pivotal Phase 3 studies evaluating soticlestat.
  • Of these potential future payments, Ovid sold a 13% interest to Ligand Pharmaceuticals for $30 million in October 2023.
  • Financial runway: Ovid anticipates its cash runway will support operations and clinical development programs into the first half of 2026.
  • Ovid also anticipates several events for its current pipeline programs and clinical results for soticlestat from Takeda in 2024.

Aquestive Therapeutics Reports Full Year 2023 Financial Results and Provides Business Update

Retrieved on: 
Tuesday, March 5, 2024
PD, Research, FDA, ATM, Food, Growth, Anaphylaxis, Loss, PDUFA, Attention deficit hyperactivity disorder, Emergency, Safety, Therapy, Allergy, Patent, Diazepam, Patient, Serdexmethylphenidate/dexmethylphenidate, Lennox–Gastaut syndrome, Net, ADHD, Adrenaline, Clutch (eggs), Trial of the century, NDA, Riluzole, Seizure, Pharmaceutical industry

Aquestive received positive feedback in October 2023 from the U.S. Food and Drug Administration (FDA) on the Company's pivotal Phase 3 Pharmacokinetic (PK) clinical protocol for Anaphylm.

Key Points: 
  • Aquestive received positive feedback in October 2023 from the U.S. Food and Drug Administration (FDA) on the Company's pivotal Phase 3 Pharmacokinetic (PK) clinical protocol for Anaphylm.
  • Aquestive commenced dosing in December 2023 in the Phase 3 pivotal PK clinical study of Anaphylm.
  • Non-GAAP adjusted EBITDA loss was $2.8 million in the fourth quarter 2023, compared to a $9.6 million loss in the fourth quarter 2022.
  • During the fourth quarter 2023, the Company accessed capital net proceeds of $3.7 million under its "At-the-Market" (ATM) facility.

Marinus Pharmaceuticals Provides Business Update and Reports Fourth Quarter and Full Year 2023 Financial Results

Retrieved on: 
Tuesday, March 5, 2024
Health, FDA, Other Health, General Health, Clinical Trials, Pharmaceutical, Biotechnology, Human services, Therapy, Research, API, Investment, Ganaxolone, Food, CDKL5 deficiency disorder, Database, Epilepsy, TSC, Administration, Lennox–Gastaut syndrome, Patient, Security (finance), Medication, Development, NDA, Pharmaceutical industry

Marinus Pharmaceuticals , Inc. (Nasdaq: MRNS), a pharmaceutical company dedicated to the development of innovative therapeutics to treat seizure disorders, today reported business highlights and financial results for the fourth quarter and year ended December 31, 2023.

Key Points: 
  • Marinus Pharmaceuticals , Inc. (Nasdaq: MRNS), a pharmaceutical company dedicated to the development of innovative therapeutics to treat seizure disorders, today reported business highlights and financial results for the fourth quarter and year ended December 31, 2023.
  • For the fiscal year 2024, the Company expects ZTALMY U.S. net product revenues of between $32 and $34 million.
  • At December 31, 2023, the Company had cash, cash equivalents and short-term investments of $150.3 million, compared to cash and cash equivalents of $240.6 million at December 31, 2022.
  • Selected Financial Data (in thousands, except share and per share amounts)

Avicanna Obtains Its First Indication-Specific Drug Registration with Trunerox™

Retrieved on: 
Tuesday, February 13, 2024
Health authority, Altea, TSX, SAS, GMP, Dravet syndrome, LGS, Patient, CBD, Lennox–Gastaut syndrome, Cannabidiol, Seizure, Pharmaceutical industry

“The approval of our first pharmaceutical product is an exceptionally significant milestone and a major step towards our long-term vision as a biopharmaceutical company with the aim to serve patients with unmet medical needs.

Key Points: 
  • “The approval of our first pharmaceutical product is an exceptionally significant milestone and a major step towards our long-term vision as a biopharmaceutical company with the aim to serve patients with unmet medical needs.
  • It is also rewarding to be able to deliver this medication for such a critical medical condition at an accessible price through our vertical,” stated Aras Azadian, CEO.
  • The approval allows Avicanna to manufacture and commercialize Trunerox in Colombia with approved indications and claims associated to the treatment for seizures related to Lennox-Gastaut Syndrome (LGS) and Dravet Syndrome (DS).
  • Lennox-Gastaut Syndrome (LGS) and Dravet Syndrome (DS) are two of the various, rare epileptic disorders classified as epileptic encephalopathies.

Human medicines European public assessment report (EPAR): Inovelon, rufinamide, Date of authorisation: 16/01/2007, Revision: 24, Status: Authorised

Retrieved on: 
Tuesday, January 2, 2024
Patient, Liver, Lennox–Gastaut syndrome, Medical Subject Headings, Fungal infection, Marketing, Triazole, INN, Fatigue, Allergy, ATC, International, Headache, Disease, Ageing, Language, Blood, Sodium, Brain, Profile, Seizure, Dizziness, Water, European Medicines Agency, Learning disability, Food, Tablet, Select, Human, Anatomy, Somnolence, Vomiting, IIA, Medical device

Human medicines European public assessment report (EPAR): Inovelon, rufinamide, Date of authorisation: 16/01/2007, Revision: 24, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Inovelon, rufinamide, Date of authorisation: 16/01/2007, Revision: 24, Status: Authorised

Marinus Pharmaceuticals Announces Seven Presentations at AES 2023, New Publication in Epilepsia and Results From the Second Generation Formulation MAD Study

Retrieved on: 
Monday, November 20, 2023
Research, Finance, Neurology, FDA, Clinical Trials, Professional Services, Biotechnology, Pharmaceutical, Health, Science, Ganaxolone, American Epilepsy Society, CDKL5 deficiency disorder, Annual general meeting, Lennox–Gastaut syndrome, Efficacy, Treatment, Marinus, IND, Epilepsy, Clinical trial, Serum, Patient, Seizure, Status epilepticus, Therapy, CDD, Abstract, Kinetics, Marigold, Physician, Medication, AES, Safety, Pharmaceutical industry, Dietary supplement

Marinus will also host a scientific exhibit showcasing a series of posters highlighting the potential of ganaxolone in the treatment of refractory seizure disorders.

Key Points: 
  • Marinus will also host a scientific exhibit showcasing a series of posters highlighting the potential of ganaxolone in the treatment of refractory seizure disorders.
  • Also announced today, preliminary data from a Phase 1 MAD study of a second generation ganaxolone formulation demonstrated linear kinetics through a wide dose range that could allow individualization of treatment in patients with refractory epilepsy, a key goal for the second generation formulation.
  • The Company now anticipates initiating a clinical trial in Lennox-Gastaut syndrome with a second generation formulation in 2025.
  • While development of the second generation formulation proceeds, Marinus intends to explore new clinical programs for ZTALMY oral suspension in other refractory epilepsies in the second half of 2024.

Marinus Pharmaceuticals Provides Business Update and Reports Third Quarter 2023 Financial Results

Retrieved on: 
Tuesday, November 7, 2023
Professional Services, Health, FDA, Finance, Clinical Trials, Pharmaceutical, Biotechnology, Biomedical Advanced Research and Development Authority, Research, Security (finance), NMPA, Therapy, Medication, Ganaxolone, SG, Human services, G&A, Marinus, Administration for Strategic Preparedness and Response, National Medical Products Administration, GAAP, Center for Drug Evaluation and Research, BARDA, MAD, Lennox–Gastaut syndrome, Administration, R, Development, RAISE, CDE, Epilepsy, RSE, API, TSC, NDA, U.S. Department of Defense Strategy for Operating in Cyberspace, Office of Inspector General, U.S. Department of Health and Human Services, Investment, Patient, Status epilepticus, Pharmaceutical industry, Fine chemical, Cryptocurrency, CDD

Marinus Pharmaceuticals , Inc. (Nasdaq: MRNS), a pharmaceutical company dedicated to the development of innovative therapeutics to treat seizure disorders, today reported business highlights and financial results for the third quarter ended September 30, 2023.

Key Points: 
  • Marinus Pharmaceuticals , Inc. (Nasdaq: MRNS), a pharmaceutical company dedicated to the development of innovative therapeutics to treat seizure disorders, today reported business highlights and financial results for the third quarter ended September 30, 2023.
  • Dr. Braunstein continued, “We remain acutely focused on advancing our Phase 3 clinical trials in refractory status epilepticus and tuberous sclerosis complex.
  • Net product revenue consists of ZTALMY product sales, which was launched in the U.S. in the third quarter of 2022.
  • Selected Financial Data (in thousands, except share and per share amounts)