Pipeline news

• Epic Sciences Expands Executive Leadership Team

  09 September 2019

  

  Epic Sciences, Inc. today announced the appointment of Joel Smith as its general counsel and executive vice president of corporate development. Mr. Smith joins the company's impressive roster of industry veterans.

• REGENXBIO Announces Exclusive Worldwide Option and License Agreement with Clearside Biomedical for Evaluation of In-Office Delivery Platform for RGX-314

  04 September 2019

  

  REGENXBIO Inc.  (Nasdaq: RGNX), a leading clinical-stage biotechnology company seeking to improve lives through the curative potential of gene therapy based on its proprietary NAV® Technology Platform, and  Clearside Biomedical, Inc.  (Nasdaq: CLSD), a biopharmaceutical company dedicated to developing and delivering treatments that restore and preserve vision for people with serious back of the eye diseases, today announced an option and license agreement for exclusive worldwide rights to Clearside's proprietary, in-office SCS Microinjector™ for the delivery of RGX-314 to the suprachoroidal space to treat wet age-related macular degeneration (wet AMD), diabetic retinopathy (DR) and other conditions for which anti-vascular endothelial growth factor (anti-VEGF) treatment is currently the standard of care.  REGENXBIO  plans to evaluate RGX-314 using Clearside's SCS Microinjector for in-office, non-surgical delivery into the suprachoroidal space, while continuing to advance its RGX-314 subretinal delivery program currently in development for wet AMD and DR.

• Clearside Biomedical Provides New Drug Application Update for XIPEREᵀᴹ (triamcinolone acetonide suprachoroidal injectable suspension)

  22 August 2019

  

  Clearside Biomedical , Inc. (Nasdaq:CLSD), a biopharmaceutical company dedicated to developing and delivering treatments that restore and preserve vision for people with serious back of the eye diseases, announced today an update regarding the Company’s 505(b)(2) New Drug Application (NDA) for XIPERETM (triamcinolone acetonide suprachoroidal injectable suspension) with the  U.S. Food and Drug Administration  ( FDA ).

• binx health Appoints Healthcare Industry Veteran Gail Marcus to Board of Directors

  12 August 2019

  

  binx health, the pioneer in anywhere, anytime testing for women's health, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its first-of-kind, highly sensitive and specific, molecular point-of-care (POC) diagnostic testing platform, the binx io®.  The binx ioplatform is a rapid, qualitative, fully-automated test, designed to be easy to use, and intended for use in POC or clinical laboratory settings, providing the world's first sample-to-answer result in about 30 minutes for the detection of chlamydia (CT) and gonorrhea (NG)—the two most tested-for STIs globally. 

• Domain Associates-backed OcuNexus Therapeutics Making Significant Progress with Inflammasome Inhibition Program in Ophthalmic Disease with Key Addition to Board of Directors

  08 August 2019

  

  Eyevance Pharmaceuticals, a Fort Worth-based pharmaceutical company committed to developing and commercializing innovative and impactful ophthalmic products, today announced a worldwide licensing agreement with OcuNexus Therapeutics for NEXAGON®, a 30-base antisense oligomer being developed for the orphan indication of persistent corneal epithelial defect (PED) nonresponsive to standard of care.

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

  08 August 2019

  

  Marinus Pharmaceuticals, Inc. (Nasdaq: MRNS), a pharmaceutical 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 second quarter ended June 30, 2019.

• Clearside Biomedical Announces Second Quarter 2019 Financial Results and Provides Corporate Update

  07 August 2019

  

  Clearside Biomedical , Inc. (NASDAQ:CLSD), a biopharmaceutical company dedicated to developing and delivering treatments that restore and preserve vision for people with serious back of the eye diseases, today reported financial results for the second quarter of 2019 and provided a corporate update.

• Syndax Pharmaceuticals Reports Second Quarter 2019 Financial Results and Provides Clinical and Business Update

  07 August 2019

  

  Syndax Pharmaceuticals, Inc.  (Nasdaq: SNDX), a clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies, today reported its financial results for the second quarter ended  June 30, 2019 . In addition, the Company provided a clinical and business update. As of  June 30, 2019 , Syndax had  $80.5 million  in cash, cash equivalents and short-term investments.

• Syndax Pharmaceuticals Announces FDA Clearance of IND Application for Targeted Menin Inhibitor SNDX-5613 for Relapsed/Refractory Acute Leukemias

  10 July 2019

  

  Syndax Pharmaceuticals, Inc.  (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 cleared the Company's Investigational New Drug (IND) application to begin a Phase 1/2 trial for SNDX-5613, a targeted Menin inhibitor, in patients with relapsed/refractory (R/R) acute leukemias.

• Clearside Biomedical Announces License Agreement with Aura Biosciences for Suprachoroidal Space Microinjector™ Designed to Optimize Ocular Oncology Drug Delivery

  09 July 2019

  

  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 its entry into a worldwide licensing agreement with Aura Biosciences for the use of Clearside’s Suprachoroidal Space (SCS) Microinjector™ to deliver Aura’s proprietary drug candidates into the SCS for the potential treatment of certain ocular cancers, including choroidal melanoma.