Theratechnologies Inc T.TH

Alternate Symbol(s): THTX

Healthcare Biotechnology

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.

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Theratechnologies Inc

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Post by jeffm34on Apr 05, 2021 1:06pm

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EMA vs. FDA

"lack of harmony between the FDA and the EMA complicates the development pathway for NASH:50 While the FDA only requires the achievement of one NASH endpoint (improvement of ≥1 stage in fibrosis with no worsening of NASH or improvement in NASH resolution with no worsening of fibrosis)51, the EMA’s draft guidance requires efficacy in both these endpoints.52 This will likely limit or delay approvals of first movers in the major European markets."

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