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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Comment by bfwon Feb 26, 2019 10:00pm

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Post# 29417605

RE:RE:RE:RE:RE:RE:Some thoughts

Its all become more complicated with ADCs and peptides attached to previously approved drugs.

https://www.choate.com/images/content/1/3/v2/1318/Lyon-Sahr-Inside-FDA-Regulation-Of-Antibody-Drug-Conjugates.pdf

bfw

jfm1330 wrote: From FDA:

New chemical entity means a drug that contains no active moiety that has been approved by FDA in any other NDA submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act.

bfw wrote: Thankfully, the FDA will view the peptide linked to a conventional chemotherapeutic as a new chemical entity :)

bfw