Pipeline news

• Syndax Pharmaceuticals Reports Third Quarter 2018 Financial Results and Provides Clinical and Business Update

  05 November 2018

  

  Syndax Pharmaceuticals, Inc. ("Syndax," the "Company" or "we") (Nasdaq: SNDX), a clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies, today announced it will provide an update on E2112, its NCI-sponsored, ECOG-ACRIN led pivotal trial of entinostat plus exemestane in hormone receptor positive, human epidermal growth factor receptor 2 negative (HR+, HER2-) breast cancer as well as its registration strategy for entinostat in combination with KEYTRUDA® (pembrolizumab) in patients with non-small cell lung cancer (NSCLC).

• Presentation of Additional Analyses of Clearside’s PEACHTREE Clinical Trial Data Further Supports Potential of XIPERE™ in Treating Uveitic Macular Edema

  29 October 2018

  

  Clearside Biomedical, Inc. (NASDAQ:CLSD), a biopharmaceutical company dedicated to developing treatments that restore and preserve vision for people with serious eye diseases, announced today that additional  data from PEACHTREE, the company’s pivotal Phase 3 trial of XIPERE™ (formerly “suprachoroidal CLS-TA”) in patients with uveitic macular edema, were presented at the  American Academy of Ophthalmology  (“AAO”) 2018 Annual Meeting by  Rahul N. Khurana , MD, Vitreoretinal Surgeon at  Northern California Retina Vitreous Associates , Clinical Associate Professor in Ophthalmology at  UCSF Medical Center , and a Principal Investigator for PEACHTREE. 

• Medicare Establishes Final Local Coverage Determination (LCD) for Use of the Oncotype DX® AR-V7 Nucleus Detect™ Test in Patients with Metastatic Castrate Resistant Prostate Cancer, Effective December 10

  29 October 2018

  

  Epic Sciences, Inc. (Epic) and Genomic Health, Inc. (Nasdaq: GHDX) announced today that Palmetto GBA, a Medicare Administrative Contractor that assesses molecular diagnostic technologies, has issued a positive final local coverage determination (LCD) for the Oncotype DX® AR-V7 Nucleus Detect™ test. The final LCD recommends Medicare coverage for use of the test effective December 10, 2018, throughout the United States to help determine which patients with metastatic castrate resistant prostate cancer (mCRPC) may benefit from continued androgen receptor signaling inhibitor (ARSi) therapy, such as enzalutamide, abiraterone and apalutamide, as well as those who are resistant who may benefit from chemotherapy.

• Marinus Pharmaceuticals Provides Business Update and Third Quarter 2018 Financial Results

  29 October 2018

  

  Marinus Pharmaceuticals, Inc. (Nasdaq:MRNS), a biopharmaceutical company dedicated to the development of innovative therapeutics to treat epilepsy and neuropsychiatric disorders, today provided a business update on its clinical development activities and reported its financial results for the third quarter ended September 30, 2018.

• Clearside Biomedical Appoints Thomas A. Ciulla, M.D., MBA as Chief Medical Officer

  25 October 2018

  

  Clearside Biomedical, Inc. (NASDAQ:CLSD), a biopharmaceutical company dedicated to developing treatments that restore and preserve vision for people with serious eye diseases, today announced the appointment of  Thomas A. Ciulla , M.D., M.B.A. to the position of Chief Medical Officer.

• Syndax to Host Conference Call to Provide Update on the Phase 3 Breast Cancer Trial (E2112) and to Announce its Registration Trial of Entinostat with Keytruda in PD-(L)1 Refractory Non-Small Cell Lung Cancer

  25 October 2018

  

  Syndax Pharmaceuticals, Inc. ("Syndax," the "Company" or "we") (Nasdaq: SNDX), a clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies, today announced it will provide an update on E2112, its NCI-sponsored, ECOG-ACRIN led pivotal trial of entinostat plus exemestane in hormone receptor positive, human epidermal growth factor receptor 2 negative (HR+, HER2-) breast cancer as well as its registration strategy for entinostat in combination with KEYTRUDA® (pembrolizumab) in patients with non-small cell lung cancer (NSCLC).

• Results from Celtaxsys’ Acebilustat Phase 2 Trial in Cystic Fibrosis Patients Showing Clinically Meaningful Improvement in Pulmonary Exacerbations Presented at the North American Cystic Fibrosis Conference

  22 October 2018

  

  Celtaxsys, Inc., a clinical stage pharmaceutical development company focused on advancing treatments for patients with rare inflammatory diseases, today announced that results from the EMPIRE-CF Phase 2 study evaluating its investigational oral, once daily product, acebilustat, for the treatment of cystic fibrosis (CF) in 200 patients were presented at the North American Cystic Fibrosis Conference (NACFC) held October 18-20, 2018 in Denver, Colorado.  

• Clearside Biomedical Appoints Veteran Supply Chain Executive, Thomas Crawford, as Vice President, Supply Chain

  19 October 2018

  

  Clearside Biomedical, Inc. (NASDAQ:CLSD), a biopharmaceutical company dedicated to developing treatments that restore and preserve vision for people with serious eye diseases, today announced the appointment of  Thomas Crawford , CSCP, as Vice President, Supply Chain.

• Marinus Pharmaceuticals Names Dr. Rolando Gutíerrez-Esteinou as VP of Clinical Development and Pharmacovigilance

  10 October 2018

  

  Marinus Pharmaceuticals, Inc. (Nasdaq:MRNS), a biopharmaceutical company dedicated to the development of innovative therapeutics to treat epilepsy and neuropsychiatric disorders, announced the appointment of Rolando Gutíerrez-Esteinou, M.D., as Vice President of Clinical Development and Pharmacovigilance where he will primarily be responsible for the medical leadership of our postpartum depression (PPD) programs and drug safety.

• Atlas Genetics Announces Company Rebranding, Changes Name to Binx Health

  08 October 2018

  

  Atlas Genetics, a pioneer in near-patient testing solutions, has been renamed Binx Health, and has aligned with additional healthcare pioneers as it redefines new categories of convenient testing where people live, work and shop.