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 > Just an excuse to sell

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Comment by scarlet1967on Jan 23, 2024 3:44pm

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Post# 35841537

RE:RE:Just an excuse to sell

I also believe the drop isn't warranted and the drug gets approved eventually. I definitely believe the company should communicate the reason for the extension and elaborate on what if any additional actions are planned to deal with the enquiries if any. There is no reason for not being more specific. There have cases when FDA has extended their review process due to resource shortages also of course there could be other factors. The company will have to reveal it at some point if FDA is asking for additional information so if that's the case why not in the same press release? It just doesn't make sense to me.

palinc2000 wrote: The PR could have been more informative,I may be wrong but I somehow doubt that the Letter from FDA was just a one sentence document with absolutely no reasons given for the delay...

Of course it could have been worst with a CRL ....
I still think it will be approved and the market reaction is irrational since the SP did not include with the recent retracement any value for F 8.....

scarlet1967 wrote:

PDUFA goal dates are set after a regulatory filing is accepted, the dates aren't set in stone. The issue is they said "Further information will be provided in due course". One would expect if FDA was asking for additional information it should be included in the press release today but THTX loves opacity. Even if FDA wants more data it obviously doesn't mean the drug will

not get approved. As per Marathon there have been so many amendments but it seems like among others the condition for F8 approval by March 31, 2024 has been removed which costed company and its shareholders $.

It seems like due to previous miss steps and statements(like today's) which can be interpreted negatively anything not clear can be used as an excuse for selling. It's worth mentioning the sBLA was received and approved by FDA for their "substantial" review. Point is it could only be a bureaucratic delay which isn't unusual, it is all about clear communication otherwise the market expects the worse and for me the clear communication and lack of it is a major issue which company hasn't addressed yet and should!

"to remove the obligation to maintain at all times liquidity in the amount of US$30 million if the F8 formulation of tesamorelin is not approved by the United States Food and Drug Administration (“FDA”) by March 31, 2024;"

https://ca.finance.yahoo.com/news/theratechnologies-announces-agreement-principle-marathon-113000682.html