Ganaxolone

Marinus Pharmaceuticals Provides Strategic Update at Virtual R&D Event

Retrieved on: 
Tuesday, October 5, 2021
Biotechnology, Pharmaceutical, Health, Other Health, Clinical trial, Annual report, NDA, Security (finance), Epilepsy, Therapy, European Medicines Agency, Prodrug, Private Securities Litigation Reform Act, U.S. Securities and Exchange Commission, FDA, GABAA, Adult, Form 10-K, Marketing, MAA, Growth, CDKL5, Risk, COVID-19, Brain, Forward-looking statement, Safety, CDD, EMA, Pharmaceutical industry, Ganaxolone, Marinus Pharmaceuticals, GANAXOLONE, MARINUS PHARMACEUTICALS

Ganaxolone exhibits anti-seizure and anti-anxiety activity via its effects on synaptic and extrasynaptic GABAA receptors.

Key Points: 
  • Ganaxolone exhibits anti-seizure and anti-anxiety activity via its effects on synaptic and extrasynaptic GABAA receptors.
  • 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.
  • Any forward-looking statements that we make in this press release speak only as of the date of this press release.

Marinus Pharmaceuticals Announces Virtual R&D Event on October 5, 2021

Retrieved on: 
Tuesday, September 28, 2021
Biotechnology, Pharmaceutical, Health, Other Health, Orion Corporation, Annual report, Security (finance), Epilepsy, Therapy, Private Securities Litigation Reform Act, Drug, U.S. Securities and Exchange Commission, Webcast, GABAA, Medication, Adult, Senior, Form 10-K, Ganaxolone, CDKL5, Brain, Forward-looking statement, Marinus, Status epilepticus, Bureau of Oceans and International Environmental and Scientific Affairs, Pharmaceutical industry, Management

(Nasdaq: MRNS), a pharmaceutical company dedicated to the development of innovative therapeutics to treat seizure disorders, will host a virtual R&D event for investors and analysts on Tuesday, October 5, 2021, from 9:00 a.m. to 12:00 p.m. Eastern Time.

Key Points: 
  • (Nasdaq: MRNS), a pharmaceutical company dedicated to the development of innovative therapeutics to treat seizure disorders, will host a virtual R&D event for investors and analysts on Tuesday, October 5, 2021, from 9:00 a.m. to 12:00 p.m. Eastern Time.
  • Steven Pfanstiel, Chief Financial Officer, will provide a financial overview and discuss the Orion Corporation collaboration.
  • Joe Hulihan, M.D., Chief Medical Officer, will discuss IV ganaxolone clinical development program updates across the continuum in status epilepticus.
  • Marinus Pharmaceuticals, Inc. is a pharmaceutical company dedicated to the development of innovative therapeutics to treat seizure disorders.

Global Epilepsy Pipeline Landscape Report 2021: Comprehensive Insights for 70+ Companies and 70+ Pipeline Drugs - ResearchAndMarkets.com

Retrieved on: 
Tuesday, September 28, 2021
Health, Pharmaceutical, A2, Food, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, CNS, Clinical trial, News, Protocol, Therapy, ODD, COMP, IDH1, Pharmacokinetics, IIA, Lists of diseases, II, Review, Research, Mergers and acquisitions, Channel modulator, PAM, Central nervous system disease, Cannabidiol, Committee, European Medicines Agency, GW Pharmaceuticals, A3, FDA, Fast Track, Patient, GABAA, Adult, Lennox–Gastaut syndrome, Ganaxolone, Ageing, Lorazepam, Status epilepticus, KCNQ2, Photosensitive epilepsy, ES, Dravet syndrome, Safety, Seizure, Lists of World Heritage Sites, GABAergic, A5, EMA, Discovery, Pharmaceutical industry

This Epilepsy - Pipeline Insight, 2021 provides comprehensive insights about 70+ companies and 70+ pipeline drugs in Epilepsy pipeline landscape.

Key Points: 
  • This Epilepsy - Pipeline Insight, 2021 provides comprehensive insights about 70+ companies and 70+ pipeline drugs in Epilepsy pipeline landscape.
  • The companies and academics are working to assess challenges and seek opportunities that could influence Epilepsy R&D.
  • The therapies under development are focused on novel approaches to treat/improve Epilepsy.
  • This segment of the Epilepsy report encloses its detailed analysis of various drugs in different stages of clinical development, including phase II, I, preclinical and Discovery.

Marinus Pharmaceuticals Announces FDA Acceptance for Filing and Priority Review of New Drug Application for Ganaxolone in CDKL5 Deficiency Disorder

Retrieved on: 
Monday, September 20, 2021
Health, FDA, Genetics, General Health, Clinical Trials, Pharmaceutical, Biotechnology, Food, Clinical trial, Annual report, Somnolence, Review, Patient, NDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Epilepsy, Therapy, Security (finance), Private Securities Litigation Reform Act, U.S. Securities and Exchange Commission, FDA, Oaktree Capital Management, GABAA, Medication, Marigold, Adult, Advisory Committee, EAP, RPD, Form 10-K, Marketing, Genetic disorder, Ganaxolone, New Drug Application, Growth, CDKL5, Risk, COVID-19, Priority review, PDUFA, X chromosome, Brain, Forward-looking statement, Safety, CDD, Mutation, Seizure, Authorization, Pharmaceutical industry, CDKL5 Deficiency Disorder, Ganaxolone, Marinus Pharmaceuticals, CDKL5 DEFICIENCY DISORDER, GANAXOLONE, MARINUS PHARMACEUTICALS

The NDA was granted Priority Review designation and the FDA assigned a Prescription Drug User Fee Act (PDUFA) action date of March 20, 2022.

Key Points: 
  • The NDA was granted Priority Review designation and the FDA assigned a Prescription Drug User Fee Act (PDUFA) action date of March 20, 2022.
  • Ganaxolone received orphan drug designation and Rare Pediatric Disease (RPD) designation for CDD in June 2017 and July 2020 , respectively.
  • If the NDA is approved, Marinus is eligible to receive a RPD Priority Review Voucher that may be sold or transferred.
  • In its acceptance letter, the FDA indicated that it is not currently planning to hold an advisory committee meeting to discuss the application.

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

Retrieved on: 
Thursday, September 9, 2021
Biotechnology, General Health, Pharmaceutical, Health

(Nasdaq: MRNS), a pharmaceutical company dedicated to the development of innovative therapeutics to treat seizure disorders, today announced the grant of inducement awards to five 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 five 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 14,313 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.

European Medicines Agency Grants Marinus Pharmaceuticals Accelerated Assessment of Ganaxolone for Treatment of CDKL5 Deficiency Disorder

Retrieved on: 
Thursday, August 26, 2021
Biotechnology, Pharmaceutical, Health, Clinical Trials, Private Securities Litigation Reform Act, Pharming, Annual report, Regulatory affairs, CDKL5, EMA, Epilepsy, CHMP, CDD, Ganaxolone, Marigold, Therapy, Genetic disorder, Orion, Growth, European Directive on Traditional Herbal Medicinal Products, U.S. Securities and Exchange Commission, MAA, Seizure, European Medicines Agency, Food, Somnolence, Committee, Committee for Medicinal Products for Human Use, Marketing, NDA, Forward-looking statement, GABAA, Review, Mutation, Public health, X chromosome, Clinical trial, Medication, Senior, Safety, Adult, Patient, Marinus, FDA, Brain, COVID-19, Orion Corporation, Security (finance), Form 10-K, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Pharmaceutical industry, Vaccine

If approved, our collaboration with Orion Corporation supports our efforts to bring ganaxolone to European markets as quickly as possible for CDD patients who may benefit.

Key Points: 
  • If approved, our collaboration with Orion Corporation supports our efforts to bring ganaxolone to European markets as quickly as possible for CDD patients who may benefit.
  • Accelerated assessment is granted by the CHMP when a medicinal product is expected to be of major public health interest and therapeutic innovation.
  • CDKL5 deficiency disorder (CDD) is a serious and rare genetic disorder that is caused by a mutation of the cyclindependent kinaselike 5 (CDKL5) gene, located on the X chromosome.
  • Marinus Pharmaceuticals, Inc. is a pharmaceutical company dedicated to the development of innovative therapeutics to treat seizure disorders.

Marinus Pharmaceuticals to Present at Multiple Upcoming Investor Conferences

Retrieved on: 
Wednesday, August 25, 2021
Pharmaceutical, Health, Clinical Trials, GABAA, Time, Investor, Marinus, Epilepsy, Brain, Therapy, Medication, Adult, Event, CDKL5, Ganaxolone, Pharmaceutical industry, Management

Marinus Pharmaceuticals, Inc .

Key Points: 
  • Marinus Pharmaceuticals, Inc .
  • (Nasdaq: MRNS), a pharmaceutical company dedicated to the development of innovative therapeutics to treat seizure disorders, today announced that members of its leadership team will present at the following investor conferences in September.
  • The company will also be hosting a virtual R&D Day where it will provide a clinical update and commercial overview on its pipeline programs.
  • Marinus Pharmaceuticals, Inc. is a pharmaceutical company dedicated to the development of innovative therapeutics to treat seizure disorders.

Marinus Pharmaceuticals Reports Topline Ganaxolone Phase 2 Open-Label Results in Tuberous Sclerosis Complex and Receives FDA Orphan Drug Designation

Retrieved on: 
Tuesday, August 17, 2021
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Patients who met eligibility criteria were able to continue ganaxolone treatment during a 24-week extension to the trial.

Key Points: 
  • Patients who met eligibility criteria were able to continue ganaxolone treatment during a 24-week extension to the trial.
  • A global Phase 3 randomized, double blind, placebo-controlled trial (TrustTSC) of adjunctive ganaxolone in approximately 160 TSC patients is expected to begin enrollment during Q4 2021.
  • The FDA has granted orphan drug designation to ganaxolone for treatment in TSC.
  • Marinus Pharmaceuticals, Inc. is a pharmaceutical company dedicated to the development of innovative therapeutics to treat seizure disorders.

Marinus Pharmaceuticals Provides Business Update and Reports Second Quarter 2021 Financial Results

Retrieved on: 
Tuesday, August 10, 2021
Research, FDA, Clinical Trials, Biotechnology, Other Health, Health, Pharmaceutical, Other Science, Science, BARDA, Medication, Priority review, CDD, RSE, Patient, FDA, European Medicines Agency, Food, Neurology, RAISE, RPD, COVID-19, Benzodiazepine, Biomedical Advanced Research and Development Authority, Marketing, U.S. Securities and Exchange Commission, Randomness, R, IV, Orion Corporation, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Safety, Investment, Leadership, Review, Orion, TSC, Seizure, Oaktree Capital Management, Research, Drug development, GAAP, Therapy, EMA, Epilepsy, Patent, Partnership, Development, NDA, Marinus, General Administration of Sport of China, Johns Hopkins, Security (finance), Johns Hopkins Hospital, Pharmaceutical industry, Cryptocurrency, Animal, Lithium, Ganaxolone, Marinus Pharmaceuticals, GANAXOLONE, MARINUS PHARMACEUTICALS

(Nasdaq: MRNS), a pharmaceutical company dedicated to the development of innovative therapeutics to treat seizure disorders, today provided an update on its clinical and regulatory development activities and reported its financial results for the second quarter ended June 30, 2021.

Key Points: 
  • (Nasdaq: MRNS), a pharmaceutical company dedicated to the development of innovative therapeutics to treat seizure disorders, today provided an update on its clinical and regulatory development activities and reported its financial results for the second quarter ended June 30, 2021.
  • Orions leadership in the European rare orphan disease market and its ability to commercialize both oral and IV ganaxolone makes them a strong partner.
  • 2021 BARDA contract revenues are projected to be in the range of $7 to $10 million for the full year.
  • Total GAAP operating expenses and stock-based compensation estimates remain unchanged from the prior guidance
    Selected Financial Data (in thousands, except share and per share amounts)

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

Retrieved on: 
Friday, August 6, 2021
Biotechnology, Pharmaceutical, Health, Clinical Trials, Epilepsy, Company, Cyprus Securities and Exchange Commission, Private Securities Litigation Reform Act, Brain, CDKL5, Security (finance), Board, Medication, Common stock, GABAA, Employment, Adult, Ganaxolone, Therapy, Financial compensation, Forward-looking statement, 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 five 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 five 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 45,625 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.