Pipeline news

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

  26 August 2021

  

  Marinus Pharmaceuticals, Inc. (Nasdaq: MRNS), a pharmaceutical company dedicated to the development of innovative therapeutics to treat seizure disorders, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has granted its request for accelerated assessment of its lead product candidate, ganaxolone, for the treatment of seizures associated with CDKL5 deficiency disorder (CDD), a rare, genetic epilepsy.

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

  17 August 2021

  

  Marinus Pharmaceuticals, Inc. (Nasdaq: MRNS), a pharmaceutical company dedicated to the development of innovative therapeutics to treat seizure disorders, today announced topline data from its open-label Phase 2 trial evaluating safety and efficacy of adjunctive oral ganaxolone treatment in 23 patients with seizures associated with tuberous sclerosis complex (TSC). The primary endpoint showed a median 16.6 percent reduction in 28-day primary endpoint seizure frequency relative to the four-week baseline period, with 30.4 percent of patients achieving a 50 percent or more seizure reduction. During the trial, patients with focal seizures (n=19) showed a median 25.2 percent reduction in focal seizure frequency.

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

  06 August 2021

  

  Marinus Pharmaceuticals, Inc. (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.

• Marinus Pharmaceuticals Submits New Drug Application (NDA) to FDA for Ganaxolone for the Treatment of Seizures Associated with CDKL5 Deficiency Disorder and Provides Pipeline Update

  03 August 2021

  

  Marinus Pharmaceuticals, Inc. (Nasdaq: MRNS), a pharmaceutical company dedicated to the development of innovative therapeutics to treat seizure disorders, today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the use of its lead product candidate ganaxolone, to treat seizures associated with CDKL5 deficiency disorder (CDD), a rare, genetic epilepsy. An NDA filing notification letter from the FDA is expected before the end of Q3 2021.

• Marinus Pharmaceuticals Announces Exclusive Collaboration with Orion Corporation for European Commercialization of Ganaxolone

  03 August 2021

  

  Marinus Pharmaceuticals, Inc. (Nasdaq: MRNS), a pharmaceutical company dedicated to the development of innovative therapeutics to treat seizure disorders, today announced that it has entered into an agreement with Orion Corporation whereby Orion received exclusive rights to commercialize the oral and intravenous (IV) dose formulations of ganaxolone in the European Economic Area, United Kingdom and Switzerland for CDKL5 deficiency disorder (CDD), tuberous sclerosis complex (TSC) and refractory status epilepticus (RSE).

• Marinus Pharmaceuticals Further Strengthens Board of Directors with Appointment of Santiago Arroyo, M.D., Ph.D.

  01 July 2021

  

  Marinus Pharmaceuticals, Inc. (Nasdaq: MRNS), a pharmaceutical company dedicated to the development of innovative therapeutics to treat seizure disorders, today announced the appointment of Santiago Arroyo, M.D., Ph.D., to its Board of Directors. Dr. Arroyo brings more than 30 years of experience in academic neurology and pharmaceutical research and development.

• Atea’s AT-527, an Oral Antiviral Drug Candidate, Reduces Viral Replication in Hospitalized Patients with COVID-19 in Phase 2 Interim Analysis

  30 June 2021

  

  Atea Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company engaged in the discovery and development of oral therapeutics for severe viral infections, today announced positive interim results from the global Phase 2 study evaluating AT-527 in hospitalized patients with mild-to-moderate COVID-19. Roche and Atea are jointly developing AT-527, an oral direct-acting antiviral (DAA) agent derived from Atea’s purine nucleotide prodrug platform.

• SNDX-5613 Granted FDA Fast Track Designation for the Treatment of Relapsed/Refractory Acute Leukemias

  28 June 2021

  

  Syndax Pharmaceuticals, Inc.  ("Syndax," the "Company" or "we") (Nasdaq: SNDX), a clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies, today announced that the  U.S. Food and Drug Administration  (FDA) has granted Fast Track Designation (FTD) to SNDX-5613 for the treatment of adult and pediatric patients with relapsed or refractory acute leukemias harboring a mixed lineage leukemia rearranged (MLLr) or nucleophosmin (NPM1) mutation. SNDX-5613 is the Company's highly selective, oral menin inhibitor.

• Atea Pharmaceuticals Announces Achievement of AT-527 Development Milestone Under License Agreement with Roche

  16 June 2021

  

  Atea Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company engaged in the discovery and development of oral therapeutics for severe viral infections, today announced that it has achieved a milestone associated with the development of AT-527 and expects to receive a related payment under its license agreement with Roche of $50 million. Under the license agreement, Roche and Atea are jointly developing AT-527 for the treatment of COVID-19. Atea retains rights to commercialize AT-527 in the United States and Roche has the exclusive right to commercialize AT-527 outside of the United States. 

• Atea Pharmaceuticals Appoints Claudio Avila, MB, BS, Ph.D., as Senior Vice President of Medical Affairs

  15 June 2021

  

  Atea Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company engaged in the discovery and development of oral therapeutics for severe viral infections, today announced the appointment of Claudio Avila, MB, BS, Ph.D., as Senior Vice President of Medical Affairs. Dr. Avila previously served as Executive Director, U.S. Medical Strategy and Medical Affairs for COVID-19 at Gilead Sciences.