News


  • 29 June 2017

    FDA Grants Orphan Drug Designation for Ganaxolone in CDKL5 Disorder

    FDA Grants Orphan Drug Designation for Ganaxolone in CDKL5 Disorder

    Marinus Pharmaceuticals, Inc. (Nasdaq:MRNS), a biopharmaceutical company dedicated to the development of innovative therapeutics to treat epilepsy and neuropsychiatric disorders, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to ganaxolone for the treatment of CDKL5 Disorder. Ganaxolone is currently being evaluated in children with CDKL5 Disorder in a Phase 2 clinical trial. 

  • 27 June 2017

    Marinus Pharmaceuticals Launches the Ganaxolone Clinical Program in Patients with Postpartum Depression

    Marinus Pharmaceuticals Launches the Ganaxolone Clinical Program in Patients with Postpartum Depression

    Marinus Pharmaceuticals, Inc. (Nasdaq:MRNS), a biopharmaceutical company dedicated to the development of innovative therapeutics to treat epilepsy and neuropsychiatric disorders, today announced that it has initiated its Phase 2 double-blind, placebo-controlled clinical trial to evaluate the safety, efficacy and pharmacokinetics (PK) of ganaxolone IV in women diagnosed with severe postpartum depression (Magnolia study). 

  • 08 June 2017

    Clearside BiomedicalТs TANZANITE Extension Study in Patients with Macular Edema Associated with Retinal Vein Occlusion Presented at the 40th Annual Macula Society Meeting

    Clearside BiomedicalТs TANZANITE Extension Study in Patients with Macular Edema Associated with Retinal Vein Occlusion Presented at the 40th Annual Macula Society Meeting

    Clearside Biomedical, Inc. (NASDAQ:CLSD), a late-stage biopharmaceutical company developing first-in-class drug therapies to treat back-of-the-eye diseases, announced that, today Charles C. Wykoff , MD, PhD, presented preliminary results from a non-interventional and retrospective trial (the “Extension Study”) of patients who had participated in the completed Phase 2 trial of CLS-TA for suprachoroidal administration (“suprachoroidal CLS-TA”). 74% of RVO Patients Receiving CLS-TA for Suprachoroidal Administration Together with Intravitreally Administered EYLEA® Did Not Receive Any Additional Treatment Over 9 Months.

  • 02 June 2017

    NovaDigm Therapeutics Awarded $6 Million by U.S. Department of Defense to Conduct a Phase 2a Staphylococcus aureus Vaccine Trial

    NovaDigm Therapeutics Awarded $6 Million by U.S. Department of Defense to Conduct a Phase 2a Staphylococcus aureus Vaccine Trial

    NovaDigm Therapeutics, a company developing innovative immunotherapeutics and preventative vaccines for fungal and bacterial infections, today announced awards totaling $6 million from the U.S. Department of Defense to conduct a clinical study of NDV-3A in military personnel at high risk for skin and soft tissue infections due to Staphylococcus aureus (“S. aureus”), including methicillin-resistant S. aureus (MRSA). NovaDigm will collaborate with the Uniformed Services University of the Health Sciences (USU) on the execution of the Phase 2a study among U.S. Army Infantry trainees at Fort Benning, GA.

  • 30 May 2017

    NovaMedica began construction of a pharmaceutical plant in the Kaluga region

    NovaMedica began construction of a pharmaceutical plant in the Kaluga region

    Russian pharmaceutical company NovaMedica, a portfolio company of RUSNANO, announces the start of construction of a plant for the production of sterile injectable drugs as part of its long-term strategy to localize innovative medicines and technologies of their development and production in Russia. The plant will be built in the industrial park “Vorsino” in the Kaluga region.

  • 29 May 2017

    NovaMedica appoints Alexander Kuzin as General Director (CEO)

    NovaMedica appoints Alexander Kuzin as General Director (CEO)

    Russian pharmaceutical company NovaMedica, a portfolio company of RUSNANO, announces the appointment of Alexander Kuzin to the post of General Director (CEO). This decision has taken unanimously by the Board of Directors of NovaMedica on May 26, 2017.

  • 24 May 2017

    Syndax Prices Public Offering of Common Stock

    Syndax Prices Public Offering of Common Stock

    Syndax Pharmaceuticals, Inc. (Nasdaq:SNDX) announced today the pricing of an underwritten public offering of 3,750,000 shares of its common stock at a price to the public of $13.25 per share. The gross proceeds to Syndax from this offering, before deducting underwriting discounts and commissions and estimated offering expenses, are expected to be approximately $49.7 million. The offering is expected to close on May 31, 2017, subject to customary closing conditions.

  • 23 May 2017

    Syndax Announces Proposed Public Offering of Common Stock

    Syndax Announces Proposed Public Offering of Common Stock

    Syndax Pharmaceuticals, Inc. (Nasdaq:SNDX) announced today that it plans to offer and sell, subject to market and other conditions, $50 million of its common stock in an underwritten public offering. There can be no assurance as to whether or when the offering may be completed, or the actual size or terms of the offering. Syndax also expects to grant the underwriters a 30-day option to purchase up to an additional 15% of the number of shares sold in the public offering. All of the shares in the proposed offering are to be sold by Syndax.

  • 17 May 2017

    Celtaxsys announces full enrollment of its landmark EMPIRE-CF phase 2b clinical trial assessing the potential of novel anti-inflammatory investigational therapy, oral acebilustat, to preserve lung function in CF patients

    Celtaxsys announces full enrollment of its landmark EMPIRE-CF phase 2b clinical trial assessing the potential of novel anti-inflammatory investigational therapy, oral acebilustat, to preserve lung function in CF patients

    Celtaxsys, Inc., a clinical stage pharmaceutical development company focused on advancing treatments for patients with rare pulmonary diseases, announced today the full enrollment of its phase 2b clinical trial testing its flagship anti-inflammatory drug candidate, once-daily oral acebilustat, in adult CF patients (NCT02443688). The study is investigating the potential of acebilustat to reduce lung inflammation and preserve lung function over the course of 48 weeks in CF patients at a high risk for rapid lung function decline. 

  • 16 May 2017

    Syndax Pharmaceuticals Announces Advancement of ENCORE 601 in Non-Small Cell Lung Cancer Patients with Disease Progression on or After PD-1 Therapies

    Syndax Pharmaceuticals Announces Advancement of ENCORE 601 in Non-Small Cell Lung Cancer Patients with Disease Progression on or After PD-1 Therapies

    Syndax Pharmaceuticals, Inc. ("Syndax," the "Company" or "we") (Nasdaq:SNDX), a clinical stage biopharmaceutical company focused on developing entinostat and SNDX-6352 in multiple cancer indications, today reported that the ENCORE 601 non-small cell lung cancer (NSCLC) cohort enrolling patients with disease progression on or after PD-1 therapy (programmed death receptor-1 (PD-1) and/or programmed death ligand 1, (PD-L1)) has met the pre-specified objective response threshold to advance into the second stage of the Phase 2 trial, and will re-open enrollment immediately.