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. 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.

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Theratechnologies Inc > FDA accepted Intercept’s NDA for NASH!

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Comment by Wino115on Jan 23, 2023 11:17am

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Post# 35239807

RE:FDA accepted Intercept’s NDA for NASH!

Any news validating any portions of the overall NASH therapeutic market as being potentially a commercial windfall for those getting in early is a positive for the projects in the P2/3 level. There's a lot to go for regardless of the first few entrants. That Akero market cap sort of pisses me off though....

scarlet1967 wrote:
https://ir.interceptpharma.com/news-releases/news-release-details/fda-accepts-intercepts-new-drug-application-oca-treatment-pre

How many “cases of death” have been associated with Egrifta with a known dose which have been tolerated by tens of thousands of patients??

Yet FDA has apparently accepted Ocaliva’s NDA for fibrotic NASH patients. A drug which can cause death due to inaccurate dosing guess why due to liver injury.

It will be interesting if approved to see the box warning/warnings.

Again Tesamorelin is safe with a well tolerated dose which can help potentially NASH patients but definitely won’t harm them.

“On September 21, 2017, FDA warned that the liver disease medicine Ocaliva (active ingredient obeticholic acid) is being incorrectly dosed in some patients with moderate to severe decreases in liver function, resulting in an increased risk of serious liver injury and death.

Since Ocaliva approval in May 2016, FDA received reports of 11 cases of serious liver injury and 19 cases of death associated with Ocaliva. The FDA's Adverse Event Reporting System (FAERS) includes only reports submitted to FDA, so there may be additional cases about which we are unaware.”

https://www.fda.gov/drugs/fda-drug-safety-podcasts/fda-drug-safety-podcast-fda-warns-about-serious-liver-injury-ocaliva-obeticholic-acid-rare-chronic