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Theratechnologies Inc T.TH

Alternate Symbol(s):  THTX

Theratechnologies Inc. is a Canada-based clinical-stage biopharmaceutical company. The Company is focused on the development and commercialization of therapies addressing unmet medical needs. It markets prescription products for people with human immunodeficiency viruses (HIV) in the United States. The Company's research pipeline focuses on specialized therapies addressing unmet medical needs in HIV, nonalcoholic steatohepatitis (NASH) and oncology. Its medicines include Trogarzo and EGRIFTA SV (tesamorelin for injection). Trogarzo (ibalizumab-uiyk) injection is a long-acting monoclonal antibody which binds to domain 2 of the CD4 T cell receptors. EGRIFTA SV (tesamorelin for injection) is approved in the United States for the reduction of excess abdominal fat in people with HIV who have lipodystrophy. Its portfolio includes Phase I clinical trial of sudocetaxel zendusortide (TH1902), a novel peptide-drug conjugate (PDC), in patients with advanced ovarian cancer.


TSX:TH - Post by User

Bullboard Posts
Post by thisisriskystufon Aug 23, 2018 3:21pm
285 Views
Post# 28507909

European Medicines Agency Authorizes Deferral of Paediatric

European Medicines Agency Authorizes Deferral of Paediatric MONTREAL, Aug. 20, 2018 (GLOBE NEWSWIRE) -- Theratechnologies Inc. (Theratechnologies) (TH.TO) today announced that the Paediatric Committee of the European Medicines Agency (EMA) has accepted to defer the initiation of the Paediatric Investigation Plan for Trogarzo after the application for marketing authorization in Europe for Trogarzo has been filed with the EMA. European Union regulations state that paediatric investigation plans should normally be conducted prior to an application for marketing authorization being filed for a medicinal product for human use. Notwithstanding, those regulations also provide for deferrals to avoid delaying access to other patient populations. Given the deferral granted by the EMA, Theratechnologies can now focus on finalizing the application for marketing authorization for Trogarzo in Europe. Europe represents a significant market for Trogarzo. We want to be in a position to launch it as quickly as we can. Obtaining a deferral for the paediatric investigation plan represents another major step towards meeting that objective, said Luc Tanguay, President and Chief Executive Officer, Theratechnologies Inc.
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