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Theratechnologies Inc T.TH

Alternate Symbol(s):  THTX

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.


TSX:TH - Post by User

Comment by scarlet1967on Jan 23, 2023 7:39pm
142 Views
Post# 35241116

RE:RE:FDA accepted Intercept’s NDA for NASH!

RE:RE:FDA accepted Intercept’s NDA for NASH!

 



Wino115 wrote: 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




 

 

 

Well their valuation is based on “EFX is a multi-modal investigational drug that holistically confronts NASH” 

So one drug multiple phase2a and b trials has convinced the market to ascribe 2.2B market cap to the company. It shows how the market is valuing NASH and its financial prospects. My frustration isn’t about Akero’s sky high valuation but THTX’s rock bottom valuation. Apparently they had arranged a meeting with cantor’s NASH analyst if I recall correctly but these analysts with all their expertise and much higher PTs have not been able to find the buyers for the stock. How about a conference call with shareholders discussing NASH or even better presenting it on various third party well followed social media platforms. I am convinced if that aspect of their investor engagement hasn’t been ignored the results of their efforts to create demand for the stock would have been much more effective than only all those meetings with institutions. This is a small cap unknown company among many others in the same industry if they want to get noticed they have to find and use all channels of communication with smaller and bigger investors. If and when they get that NASH partnership if and when they get oncology trial restarted if and when they commercial operations show decent results they absolutely need to get noticed by all segments of the market not ignored. Selling isn’t easy but one has to know how and make all the right efforts effortlessly.

 

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