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 > FDA approved Gilead’s AD

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Comment by Wino115on Apr 09, 2021 9:05am

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Post# 32965489

RE:FDA approved Gilead’s AD

This is the Immunomedics drug they bought in the $21bil deal. I think this is also why that KOL said a 3L/4L TNBC drug with a 20-30% response rate and 2 months of PF survival is a huge improvement. That seems to be the bar to meet or exceed with TH1902 for the TNBC indication.

scarlet1967 wrote: The drug can cause severe neutropenia yet it got approved due to lukewarm results, now they want to go global. It shows a drug used as a last line of defence can get approved even with serious adverse effects and..,,

“Today’s approval is the culmination of a multi-year development program and validates the clinical benefit of this important treatment in metastatic TNBC,” said Merdad Parsey, MD, PhD, Chief Medical Officer, Gilead Sciences. “Building upon this milestone, we are committed to advancing Trodelvy with worldwide regulatory authorities so that, pending their decision, Trodelvy may become available to many more people around the world who are facing this difficult-to-treat cancer.”

https://www.gilead.com/news-and-press/press-room/press-releases/2021/4/fda-approves-trodelvy-the-first-treatment-for-metastatic-triplenegative-breast-cancer-shown-to-improve-progressionfree-survival-and-overall-surviv

Trodelvy also may cause serious side effects, including:

Severe neutropenia: Neutropenia means you have abnormally low levels of neutrophils, a type of white blood cell. People with neutropenia have a much higher risk of getting serious infections. Your doctor will monitor your neutrophil counts while you are being treated with Trodelvy. If you develop neutropenia, you may be treated with a granulocyte-colony stimulating factor medicine such as Neupogen (chemical name: filgrastim), Neulasta (chemical name: pegfilgrastim), or Zarxio (chemical name: filgrastim-sndz).

Severe diarrhea: Severe diarrhea can cause dehydration, low blood pressure, and severe kidney problems. Tell your doctor about any diarrhea you have so it can be treated right away.

Trodelvy (sacituzumab govitecan): Side Effects, How it Works, and More