Theranexus

16 articles about Theranexus

• Theranexus and BBDF Win FDA Approval on Efficacy Endpoints for the Phase III Trial to Evaluate Batten-1 in CLN3 Batten Disease

  5/9/2023

  Theranexus and the Beyond Batten Disease Foundation, have announced receipt of approval from the Food and Drug Administration for the design and primary and secondary endpoints of the pivotal Phase III trial for Batten disease CLN3, at a meeting with the Division of Rare Diseases and Medical Genetics held in mid-April.

• CORRECTION FROM SOURCE: Theranexus and BBDF Win FDA Approval on Efficacy Endpoints for the Phase III Trial to Evaluate Batten-1 in CLN3 Batten Disease

  5/9/2023

  Theranexus and the Beyond Batten Disease Foundation, have announced receipt of approval from the Food and Drug Administration for the design and primary and secondary endpoints of the pivotal Phase III trial for Batten disease CLN3, at a meeting with the Division of Rare Diseases and Medical Genetics held in mid-April.

• Theranexus, BBDF and Cardiff University Present Their Novel Research on Batten-1 and Batten Disease at WORLDSymposium 2023

  2/21/2023

  Theranexus and its partners Beyond Batten Disease Foundation and Cardiff University, announced several presentations at WORLDSymposium 2023, an international scientific event focused on lysosomal diseases.

• New Advance to the Theranexus and BBDF Batten-1 Program for Juvenile Batten Disease (CLN3)

  1/5/2023

  Theranexus and the Beyond Batten Disease Foundation, have announced the initial results of their Phase I/II clinical trial for juvenile Batten disease.

• Theranexus and BBDF Obtain Orphan Drug Designation (ODD) and Rare Pediatric Disease Designation (RPDD) from the Food and Drug Administration (FDA) for BBDF-101 for Batten Disease

  8/11/2020

  Orphan Drug Designation (ODD) is a status that provides seven years of additional post-approval protection and exemption from filing fees Rare Pediatric Disease Designation (RPDD) qualifies the sponsor at the time of registration for a salable, transferable priority review voucher which can be used to speed up the approval process for another drug candidate

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  BioSpace Global Roundup, April 2

  4/2/2020

  Biopharma companies from across the globe provide updates on their pipelines and business practices.

• THERANEXUS ANNOUNCES INCLUSION OF LAST PATIENT IN PHASE II TRIAL OF DRUG CANDIDATE THN102 ON NARCOLEPSY PATIENTS

  10/29/2018

  Theranexus announces today that it has recruited the last patient in its Phase II trial, entitled "Tolerance and Efficacy of THN102 on Sleepiness in Narcoleptic Patients".

• THERANEXUS PLANS TO EXPAND ITS PHASE II PIPELINE  WITH A THIRD PROGRAM

  10/15/2018

  Preparation of a Phase II program for THN101 in patients with neuropathic pain 

• THERANEXUS ANNOUNCES ITS FIRST HALF 2018 RESULTS

  9/27/2018

  CASH POSITION AT JUNE 30, 2018: €14.9 million

• THERANEXUS OBTAINS THE AUTHORIZATION TO START A PHASE Ib CLINICAL TRIAL WITH ITS DRUG CANDIDATE THN201 IN NEUROCOGNITIVE DISORDERS DUE TO ALZHEIMER'S DISEASE

  9/26/2018

  A study aimed at demonstrating the clinical superiority of THN201 over a standard of care treatment for this severely debilitating symptom

• LYONBIOPOLE Will Unite Leading French Biotech Actors at the 2018 BIO International Convention

  5/31/2018

  Lyonbiopole the French "bio-cluster" based in the Auvergne-Rhône-Alpes region, will unite 35 innovative organizations at the 2018 edition of the BIO International Convention.

• Theranexus Announces The Appointment Of Julien Veys To The Position

  10/11/2016

• Theranexus Has Obtained An Orphan Drug Designation From The FDA For THN102 In The Treatment Of Narcolepsy

  10/4/2016

• Theranexus And Its Partners Receive Support From The FUI (French Inter-Ministry Fund) For Their Project, Cx-COG

  9/20/2016

• Theranexus Reaches Its Primary Endpoint In The Proof Of Concept Trial Of THN102 In Excessive Daytime Sleepiness (EDS)

  5/17/2016

• Theranexus: Preclinical Results Published In The Specialist Medical Journal Sleep

  3/30/2016