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 > Another update!

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Comment by qwerty22on Aug 15, 2022 10:17am

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RE:RE:Another update!

One interesting thing is the patient numbers fall in the middle of the range Paul talked about. So maybe his low and high estimates of the cost of the pivotal trial aren't so bad.

I started to look at the situation in late stage metastatic prostate cancer on the (wild at the moment) assumption that it could be their lead indication. From the (little) research I did I don't see the present approved drug situation being all that good for this cancer. Just my I'll-educated guess but I could see this indication as being another one where the fda might rush to get something approved if it shows some meaningful promise.

It seems true to me that some cancers offers pretty rapid paths based on serious unmet medical need while others have more options and so require less urgency from the regulators. It would be worth trying to gauge how each of the cancer indications THTX are chasing fit into this.

qwerty22 wrote:

If you want to dream of the fastest route to approval for TH1902 then this is a pretty good example. They didn't even make it to the end of the pivotal trial. They enrolled 152 patients. Approval came from interim analysis of 52 patients for efficacy and 101 patients for safety. The trial started in Nov 2020. The 57% ORR helps. A year and a half from start of pivotal trial to accelerated approval, amazing really.

scarlet1967 wrote: https://www.fiercepharma.com/pharma/astrazenecas-enhertu-scores-another-win-her2-mutant-non-small-cell-lung-cancer