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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. It blocks viral entry into host cells while preserving normal immunologic function. The Company is also investigating an intramuscular method of administration of Trogarzo. 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.


TSX:TH - Post by User

Comment by muslix1on Feb 27, 2024 7:54am
72 Views
Post# 35900910

RE:RE:Theratechnologies Receives Refusal to File Letter for Trogar

RE:RE:Theratechnologies Receives Refusal to File Letter for Trogar
we were aware that the approval of this sBLA for Trogarzo® IM administration could be challenging based on the results shared in October 2023 from the TMB-302 study, even though viral suppression was maintained throughout the study,” said Christian Marsolais, Ph.D., Senior Vice President and Chief Medical Officer at Theratechnologies. “We will now assess our options regarding this application.”

 if you know it will be complicated...be sure before sending it...it makes sense
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