Ganaxolone

Marinus Pharmaceuticals Announces Resumption of Phase 3 RAISE Trial in Status Epilepticus

Retrieved on: 
Thursday, May 5, 2022
Health, Clinical Trials, Research, Pharmaceutical, Science, Biotechnology, BARDA, COVID-19, Data monitoring committee, RSE, U.S. Securities and Exchange Commission, Randomness, Forward-looking statement, Private Securities Litigation Reform Act, Brain, Epilepsy, EMA, RAISE, Development, Human services, Company, Biomedical Advanced Research and Development Authority, Food, Safety, Use of Free and Open-Source Software (FOSS) in the U.S. Department of Defense, SE, Patient, Security (finance), Office of Inspector General, U.S. Department of Health and Human Services, Status epilepticus, Clinical trial, FDA, Therapy, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Benzodiazepine, Adult, Marinus, Prodrug, GABAA, Medication, IV, Assistant, Office of the Assistant Secretary for Preparedness and Response, Ganaxolone, Pharmaceutical industry

Marinus Pharmaceuticals , Inc. (Nasdaq: MRNS), a pharmaceutical company dedicated to the development of innovative therapeutics to treat seizure disorders, today announced that it has resumed screening and recruitment for the Phase 3 RAISE (Randomized Therapy in Status Epilepticus) trial in refractory status epilepticus (RSE).

Key Points: 
  • Marinus Pharmaceuticals , Inc. (Nasdaq: MRNS), a pharmaceutical company dedicated to the development of innovative therapeutics to treat seizure disorders, today announced that it has resumed screening and recruitment for the Phase 3 RAISE (Randomized Therapy in Status Epilepticus) trial in refractory status epilepticus (RSE).
  • The company continues to expect topline RAISE trial results in the second half of 2023.
  • Marinus announced in February that it was pausing recruitment in the RAISE trial after routine stability monitoring showed visible particulates of aluminum phosphate in the drug solution.
  • The resupply will also allow the Phase 2 RESET (Researching Established Status Epilepticus Treatment) trial to continue to advance.

Marinus Pharmaceuticals to Provide Business Update and Report First Quarter 2022 Financial Results on May 12, 2022

Retrieved on: 
Wednesday, April 20, 2022
General Health, Pharmaceutical, Health, Other Health, Marinus, Epilepsy, IV, Brain, Ganaxolone, Therapy, Adult, GABAA, Pharmaceutical industry, Baking

Marinus is a pharmaceutical company dedicated to the development of innovative therapeutics to treat seizure disorders.

Key Points: 
  • Marinus is a pharmaceutical company dedicated to the development of innovative therapeutics to treat seizure disorders.
  • Ganaxolone is a neuroactive steroid GABAA receptor modulator that acts on a well-characterized target in the brain known to have anti-seizure effects.
  • It is being developed in IV and oral dose formulations intended to maximize therapeutic reach to adult and pediatric patient populations in both acute and chronic care settings.
  • View source version on businesswire.com: https://www.businesswire.com/news/home/20220420005372/en/

Marinus Pharmaceuticals Announces Inducement Grants Under Nasdaq Listing Rule 5635(C)(4)

Retrieved on: 
Monday, April 18, 2022
Health, General Health, Research, Pharmaceutical, Science, Biotechnology, Board, Ganaxolone, Cyprus Securities and Exchange Commission, Adult, Security (finance), GABAA, Private Securities Litigation Reform Act, Brain, Common stock, Employment, Company, Forward-looking statement, Financial compensation, Epilepsy, Medication, Therapy, Pharmaceutical industry

(Nasdaq: MRNS), a pharmaceutical company dedicated to the development of innovative therapeutics to treat seizure disorders, today announced the grant of an inducement award to one new employee.

Key Points: 
  • (Nasdaq: MRNS), a pharmaceutical company dedicated to the development of innovative therapeutics to treat seizure disorders, today announced the grant of an inducement award to one new employee.
  • The Compensation Committee of the Board of Directors of Marinus approved the grant of a non-qualified stock option to purchase an aggregate of 13,800 shares of its common stock (the Common Stock) as inducement material to the employees entering into employment with the Company in accordance with Nasdaq Listing Rule 5635(c)(4).
  • The stock option was granted as inducement material to the employee entering into employment with Marinus in accordance with Nasdaq Listing Rule 5635(c)(4), and is subject to the terms and conditions of the applicable award agreement covering such grant.
  • Marinus Pharmaceuticals, Inc. is a pharmaceutical company dedicated to the development of innovative therapeutics to treat seizure disorders.

Marinus Pharmaceuticals Bolsters Financial Position With Drawdown of $30 Million Under Oaktree Capital Credit Facility

Retrieved on: 
Thursday, March 31, 2022
Professional Services, Health, Finance, General Health, Pharmaceutical, Banking, Biotechnology, Oaktree Capital Management, Private Securities Litigation Reform Act, Company, Risk, Marinus, Behavior, CDD, Therapy, Seizure, Trial of the century, Forward-looking statement, Caregiver, Somnolence, Adult, GABAA, Office of the Assistant Secretary for Preparedness and Response, CNS, Research, Biomedical Advanced Research and Development Authority, Status epilepticus, Incidence, DNA repair-deficiency disorder, Human services, Anticonvulsant, Food, U.S. Securities and Exchange Commission, Assistant, U.S. Department of Commerce Office of Security, Oak Tree, Office of Inspector General, U.S. Department of Health and Human Services, Security (finance), New Drug Application, BARDA, IV, RAISE, AED, Medication, Ganaxolone, Epilepsy, RSE, Suicidal ideation, Brain, NDA, Development, Depression, FDA, Allergen, Patient, CDKL5, Pharmaceutical industry, Fever

Marinus Pharmaceuticals , Inc. (Nasdaq: MRNS), a pharmaceutical company dedicated to the development of innovative therapeutics to treat seizure disorders, today announced it has received $30 million in funding under the existing Oaktree Capital Management, L.P. (Oaktree) credit agreement.

Key Points: 
  • Marinus Pharmaceuticals , Inc. (Nasdaq: MRNS), a pharmaceutical company dedicated to the development of innovative therapeutics to treat seizure disorders, today announced it has received $30 million in funding under the existing Oaktree Capital Management, L.P. (Oaktree) credit agreement.
  • In May 2021, Marinus signed a credit financing agreement with Oaktree, a leader among global investment managers specializing in alternative investments.
  • Together with this $30 million drawdown, Marinus has drawn a total of $75 million in funding, including $15 million at signing of the credit financing agreement and $30 million upon the FDAs acceptance of the CDD NDA filing in September 2021.
  • Any forward-looking statements that we make in this press release speak only as of the date of this press release.

Marinus Pharmaceuticals Announces Inducement Grants Under Nasdaq Listing Rule 5635(C)(4)

Retrieved on: 
Tuesday, March 15, 2022
Health, Infectious Diseases, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Employment, GABAA, Common stock, Private Securities Litigation Reform Act, Therapy, Medication, Forward-looking statement, Ganaxolone, Financial compensation, Security (finance), Brain, Adult, Board, Company, Cyprus Securities and Exchange Commission, Epilepsy, Pharmaceutical industry

(Nasdaq: MRNS), a pharmaceutical company dedicated to the development of innovative therapeutics to treat seizure disorders, today announced the grant of inducement awards to three new employees.

Key Points: 
  • (Nasdaq: MRNS), a pharmaceutical company dedicated to the development of innovative therapeutics to treat seizure disorders, today announced the grant of inducement awards to three new employees.
  • The Compensation Committee of the Board of Directors of Marinus approved the grant of non-qualified stock options to purchase an aggregate of 18,263 shares of its common stock (the Common Stock) as inducements material to the employees entering into employment with the Company in accordance with Nasdaq Listing Rule 5635(c)(4).
  • The stock options were granted as an inducement material to each of the employees entering into employment with Marinus in accordance with Nasdaq Listing Rule 5635(c)(4), and are subject to the terms and conditions of the applicable award agreement covering such grant.
  • Marinus Pharmaceuticals, Inc. is a pharmaceutical company dedicated to the development of innovative therapeutics to treat seizure disorders.

Marinus Pharmaceuticals Announces Delay to RAISE Phase 3 Clinical Trial in Status Epilepticus and Associated IV Ganaxolone Clinical Trials

Retrieved on: 
Tuesday, February 22, 2022
Science, Biotechnology, Research, Pharmaceutical, Health, FDA, Infectious Diseases, Clinical Trials, Risk, High-dependency unit, Therapy, Annual report, Omicron, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Growth, Security (finance), IV, GABAA, COVID-19, Medication, Prescription Drug User Fee Act, Company, Clinical trial, Private Securities Litigation Reform Act, Safety, U.S. Securities and Exchange Commission, Review, RAISE, Food, Adult, Status epilepticus, Eastern Time Zone, Brain, Orion Corporation, FDA, Epilepsy, EMA, Forward-looking statement, Marketing, CDKL5, NDA, Form 10-K, Ganaxolone, Seizure, Orion, Pharmaceutical industry

The Company is targeting resupply of clinical trial material by the end of the second quarter 2022.

Key Points: 
  • The Company is targeting resupply of clinical trial material by the end of the second quarter 2022.
  • Separately, Marinus is implementing improvements in the manufacturing process with the goal of achieving a 24-month or greater product shelf life for IV ganaxolone.
  • Timing for the Phase 2 RESET trial of adjuvant use of ganaxolone in established status epilepticus and the Phase 3 RAISE II trial (for European registration) in status epilepticus, are both expected to incur a six-month initiation delay.
  • The clinical supply interruption affects the IV formulation of ganaxolone and the IV clinical programs.

Marinus Pharmaceuticals to Provide Business Update and Announce Preliminary Fourth Quarter 2021 Financial Results on March 21, 2022

Retrieved on: 
Wednesday, February 16, 2022
Health, General Health, Research, Pharmaceutical, Science, Biotechnology, Epilepsy, Brain, Medication, Ganaxolone, GABAA, Adult, Therapy, Pharmaceutical industry, Baking

Marinus Pharmaceuticals, Inc. is a pharmaceutical company dedicated to the development of innovative therapeutics to treat seizure disorders.

Key Points: 
  • Marinus Pharmaceuticals, Inc. is a pharmaceutical company dedicated to the development of innovative therapeutics to treat seizure disorders.
  • Ganaxolone is a positive allosteric modulator of GABAA receptors that acts on a well-characterized target in the brain known to have anti-seizure, antidepressant and anti-anxiety effects.
  • Ganaxolone is being developed in IV and oral dose formulations intended to maximize therapeutic reach to adult and pediatric patient populations in both acute and chronic care settings.
  • View source version on businesswire.com: https://www.businesswire.com/news/home/20220216005461/en/

GABA Receptor Agonists Drug Market Research Report 2022: Comprehensive Insights About 25+ Companies and 25+ Pipeline Drugs - ResearchAndMarkets.com

Retrieved on: 
Thursday, February 10, 2022
Mental Health, Health, Clinical Trials, Research, Pharmaceutical, Science, New Drug Application, Food, Smoking, CDD, CDKL5, Clinical trial, Adult, GABA receptor agonist, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Therapy, Technology, Seizure, Ganaxolone, GABAA, FDA, Mergers and acquisitions, Acquisition, NDA, Metyrapone, This, Discovery, News, Nicotine, II, GABA, Pharmaceutical industry, Aroma compound

This "GABA Receptor Agonists - Pipeline Insight, 2022" report provides comprehensive insights about 25+ companies and 25+ pipeline drugs in GABA Receptor Agonists pipeline landscape.

Key Points: 
  • This "GABA Receptor Agonists - Pipeline Insight, 2022" report provides comprehensive insights about 25+ companies and 25+ pipeline drugs in GABA Receptor Agonists pipeline landscape.
  • The assessment part of the report embraces, in depth GABA Receptor Agonists commercial assessment and clinical assessment of the pipeline products under development.
  • The companies and academics are working to assess challenges and seek opportunities that could influence GABA Receptor Agonists R&D.
  • This segment of the report provides insights about the different GABA Receptor Agonists drugs segregated based on following parameters that define the scope of the report.

Marinus Pharmaceuticals Announces Inducement Grants Under Nasdaq Listing Rule 5635(C)(4)

Retrieved on: 
Thursday, February 10, 2022
Biotechnology, Pharmaceutical, Health, Mental Health, Epilepsy, Company, Brain, Forward-looking statement, Medication, Cyprus Securities and Exchange Commission, Security (finance), Private Securities Litigation Reform Act, Adult, Therapy, Common stock, Ganaxolone, GABAA, Financial compensation, Board, Employment, Pharmaceutical industry

(Nasdaq: MRNS), a pharmaceutical company dedicated to the development of innovative therapeutics to treat seizure disorders, today announced the grant of inducement awards to six new employees.

Key Points: 
  • (Nasdaq: MRNS), a pharmaceutical company dedicated to the development of innovative therapeutics to treat seizure disorders, today announced the grant of inducement awards to six new employees.
  • These restricted stock units vest in full on the first anniversary of the applicable employees start date of employment.
  • The stock options and restricted stock units were granted as an inducement material to each of the employees entering into employment with Marinus in accordance with Nasdaq Listing Rule 5635(c)(4), and are subject to the terms and conditions of the applicable award agreement covering such grant.
  • Marinus Pharmaceuticals, Inc. is a pharmaceutical company dedicated to the development of innovative therapeutics to treat seizure disorders.

Marinus Pharmaceuticals Completes In Vivo M2 Metabolite Study and Provides European Regulatory Update

Retrieved on: 
Thursday, February 3, 2022
Health, Other Health, General Health, Research, Pharmaceutical, Science, Growth, Private Securities Litigation Reform Act, Safety, Forward-looking statement, Risk, Ganaxolone, Clinical trial, Liver, Bone marrow, Brain, Committee on Herbal Medicinal Products, EMA, COVID-19, MAA, Marketing, Medication, Adult, U.S. Securities and Exchange Commission, GABAA, Orion Corporation, Epilepsy, European Medicines Agency, Marinus, NDA, FDA, Therapy, Security (finance), Form 10-K, Review, Orion, Annual report, Pharmaceutical industry

In August 2021, Marinus announced a collaboration with Orion Corporation for European commercialization of ganaxolone.

Key Points: 
  • In August 2021, Marinus announced a collaboration with Orion Corporation for European commercialization of ganaxolone.
  • The final study report is expected prior to the end of February 2022.
  • Marinus Pharmaceuticals, Inc. is a pharmaceutical company dedicated to the development of innovative therapeutics to treat seizure disorders.
  • We assume no obligation to update forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.