Ganaxolone

Marinus Pharmaceuticals Comments on Patent Challenge by Ovid Therapeutics Inc. and Provides Update on Marinus’ Post Grant Review

Retrieved on: 
Wednesday, March 27, 2024
Professional Services, Health, Neurology, Legal, Finance, General Health, Pharmaceutical, PGR, Plasma, Medication, Patent, Patient, Ganaxolone, PTAB, IPR, Marinus, Pharmacology, Inter partes review, Patent office, Therapy, Epilepsy, Status epilepticus, Pharmaceutical industry

This challenge relates to a Marinus patent for the use of ganaxolone in treating status epilepticus (SE) and refractory status epilepticus (RSE).

Key Points: 
  • This challenge relates to a Marinus patent for the use of ganaxolone in treating status epilepticus (SE) and refractory status epilepticus (RSE).
  • “Over the past two decades, Marinus has invested more than $100 million into our ganaxolone development programs in SE,” stated Dr. Scott Braunstein, Chairman and CEO of Marinus.
  • We believe this Ovid challenge is without merit and is an unfortunate distraction to the important work we do at Marinus.
  • In response to Marinus’ request for PGR, Ovid abandoned 23 of the 31 claims in its patent.

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)

Marinus Pharmaceuticals Reports Preliminary Fourth Quarter and Full Year 2023 ZTALMY® Net Product Revenue and Provides Business Update

Retrieved on: 
Thursday, January 4, 2024
Health, Neurology, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Epilepsy, Administration, Medication, Ganaxolone, Human services, Growth, Investment, Patient, Development, Therapy, 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 preliminary U.S. ZTALMY® net product revenue 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 preliminary U.S. ZTALMY® net product revenue for the fourth quarter and year ended December 31, 2023.
  • “Our commercial strategy and deep understanding of the epilepsy and rare disease space continues to drive increasing adoption of ZTALMY, establishing a strong foundation for the future of the franchise and positioning us to generate robust growth in the year ahead,” said Scott Braunstein, M.D., Chairman and Chief Executive Officer of Marinus.
  • “We expect 2024 will be another pivotal year for Marinus with two Phase 3 data readouts anticipated, beginning with topline data from the RAISE trial of IV ganaxolone in refractory status epilepticus in the second quarter followed by the TrustTSC study readout in tuberous sclerosis complex in the third quarter.
  • Over 70% of the 128 patients required in the global Phase 3 TrustTSC trial of oral ganaxolone are now enrolled with expected enrollment completion by the end of Q1 2024; total blinded discontinuation rates to date remain below 10%
    Preliminary unaudited cash, cash equivalents, and short-term investments of $150.3 million as of December 31, 2023; expected to fund the Company’s operating expenses, capital expenditure requirements, and maintain the minimum cash balance of $15 million required under the Company’s debt facility into the fourth quarter of 2024
    The preliminary fourth quarter and full-year 2023 net product revenue results and cash, cash equivalents, and short-term investments included in this release were calculated prior to the completion of an audit by the Company’s independent registered public accounting firm and are therefore subject to adjustment.

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)

Marinus Pharmaceuticals Highlights Advancing Pipeline and Commercial Strategy at Investor and Analyst Event 

Retrieved on: 
Tuesday, September 19, 2023
Pharmaceutical, Professional Services, Health, Finance, Status epilepticus, Biomedical Advanced Research and Development Authority, Therapy, Office of Inspector General, U.S. Department of Health and Human Services, Hospital, Human services, Ganaxolone, CDKL5 deficiency disorder, Medication, Administration, Development, ATM, RAISE, Patient, Investment, Administration for Strategic Preparedness and Response, Disease, Epilepsy, Washington University School of Medicine, Webcast, Growth, BARDA, Barnes-Jewish Hospital, Pharmaceutical industry, RSE, Neurology

Marinus Pharmaceuticals , Inc. (Nasdaq: MRNS), a pharmaceutical company dedicated to the development of innovative therapeutics to treat seizure disorders, is today hosting an Investor and Analyst Event in New York to review the Company’s ongoing clinical-stage programs and commercial planning activities.

Key Points: 
  • Marinus Pharmaceuticals , Inc. (Nasdaq: MRNS), a pharmaceutical company dedicated to the development of innovative therapeutics to treat seizure disorders, is today hosting an Investor and Analyst Event in New York to review the Company’s ongoing clinical-stage programs and commercial planning activities.
  • The event begins at 9 a.m.
  • “I look forward to showcasing how we are planning to deliver on our commitment to improve the lives of more patients with refractory seizure disorders during today’s Investor and Analyst Event,” said Scott Braunstein, M.D., Chairman and Chief Executive Officer of Marinus.
  • Importantly, we have extended our cash runway into the fourth quarter of 2024 through strategic use of our existing ATM facility.

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

Retrieved on: 
Thursday, August 10, 2023
Biotechnology, Neurology, Health, Pharmaceutical, Clinical Trials, RSE, Biomedical Advanced Research and Development Authority, Therapy, SG, U.S. Department of Defense Strategy for Operating in Cyberspace, European Commission Investment Plan for Europe, Human services, Office of Inspector General, U.S. Department of Health and Human Services, Lennox–Gastaut syndrome, API, CDKL5 deficiency disorder, Clinical trial, G&A, GAAP, Medication, TSC, Development, Administration, RAISE, European Commission, Patent, Patient, Investment, Administration for Strategic Preparedness and Response, Epilepsy, Ganaxolone, MAD, Growth, Security (finance), R, Research, BARDA, IND, Marigold, Pharmaceutical industry, Cryptocurrency, Fine chemical

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 second quarter ended June 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 second quarter ended June 30, 2023.
  • Recognized $4.2 million and $7.6 million in net product revenues for the three and six months ended June 30, 2023, respectively.
  • Net product revenue consists of ZTALMY product sales, which was launched in the U.S. in the third quarter of 2022.
  • At June 30, 2023, the Company had cash, cash equivalents, and short-term investments of $175.3 million, compared to $240.6 million at December 31, 2022.

European Commission approval of Ztalmy® (ganaxolone) for the adjunctive treatment of epileptic seizures associated with CDKL5 deficiency disorder

Retrieved on: 
Monday, July 31, 2023
Orion, Ganaxolone, Seizure, CDD, CDKL5 deficiency disorder, Genetic disorder, Civil service commission, Patient, CDKL5, European Commission, European, Pharmaceutical industry, EU

The European Commission has granted marketing authorisation in the European Union (EU) for Ztalmy® (ganaxolone) oral suspension for the adjunctive treatment of epileptic seizures associated with cyclin-dependent kinase-like 5 (CDKL5) deficiency disorder (CDD) in patients two to 17 years of age.

Key Points: 
  • The European Commission has granted marketing authorisation in the European Union (EU) for Ztalmy® (ganaxolone) oral suspension for the adjunctive treatment of epileptic seizures associated with cyclin-dependent kinase-like 5 (CDKL5) deficiency disorder (CDD) in patients two to 17 years of age.
  • ZTALMY may be continued in patients 18 years of age and older.
  • Ganaxolone is developed by Marinus Pharmaceuticals, Inc. and under a collaboration agreement Orion has the right to sell and market ZTALMY in Europe.
  • Following the European Commission approval, Orion is focusing on making ZTALMY available for patients in Europe and has pricing and reimbursement processes planned or underway in Europe.

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

Retrieved on: 
Thursday, May 11, 2023
Biotechnology, Finance, Health, Professional Services, Pharmaceutical, Patent, RSE, Biomedical Advanced Research and Development Authority, CV, Therapy, U.S. Department of Defense Strategy for Operating in Cyberspace, SG, Orion Corporation, Human services, United States Patent and Trademark Office, Ganaxolone, Office of Inspector General, U.S. Department of Health and Human Services, Lennox–Gastaut syndrome, API, Forest Law Enforcement and Governance Program, GAAP, Eugnosta tenacia, Medication, Development, Administration, Patient, Investment, Administration for Strategic Preparedness and Response, Marinus, Epilepsy, MAD, Security (finance), Research, FDA, BARDA, Pharmaceutical industry, Medical device, Fine chemical, Cryptocurrency, TSC, RAISE

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 first quarter ended March 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 first quarter ended March 31, 2023.
  • Entered exclusive distribution and supply agreement with Biologix for ganaxolone in select markets in the Middle East and North Africa.
  • Recognized $3.3 million in net product revenues for the three months ended March 31, 2023.
  • Net product revenue consists of ZTALMY product sales, which was launched in the U.S. in the third quarter of 2022.

Marinus Pharmaceuticals to Present at Upcoming Investor Conferences

Retrieved on: 
Wednesday, May 3, 2023
Biotechnology, Finance, Health, Professional Services, Pharmaceutical, Seizure, CV, IV, Therapy, Ganaxolone, CDKL5 deficiency disorder, Brain, CDKL5, Medication, JMP, Patient, GABAA, Epilepsy, Conference, Pharmaceutical industry, Dietary supplement

Marinus Pharmaceuticals, Inc. (Nasdaq: MRNS), a pharmaceutical company dedicated to the development of innovative therapeutics to treat seizure disorders, today announced that management will present and participate during the following conferences in May.

Key Points: 
  • Marinus Pharmaceuticals, Inc. (Nasdaq: MRNS), a pharmaceutical company dedicated to the development of innovative therapeutics to treat seizure disorders, today announced that management will present and participate during the following conferences in May.
  • RBC Annual Healthcare Conference in New York, NY
    May 16 at 10:00 a.m. E.T.
  • Links to the events can be accessed on the Investors and Media page of Marinus’ website at ir.marinuspharma.com/events-and-presentations .
  • Marinus is a commercial-stage pharmaceutical company dedicated to the development of innovative therapeutics for seizure disorders.