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 > Update from research analyst

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Comment by Maxmoeon Dec 18, 2024 3:45pm

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Post# 36368838

RE:Update from research analyst

Maxmoe wrote:
Target price $3.80 USD.

Yay! Egrifta SV PAS filed - Now On The Clock

Summary

Today, THTX announced that it filed Prior Approval Supplement (PAS) to the FDA for the current F4 formulation of Egrifta (Egrifta SV). Typically, the FDA could take up to 4 months to review. In this case, there is a chance that the review process could be expedited - Egrifta is the only FDA-approved drug for its indication and management is working closely with the FDA (shortage committee) to potentially minimize the Egrifta SV PAS review time. The company has sufficient inventory for Egrifta SV until mid-Jan 2025, and once an approval is obtained more batches are underway (LINK). Investors should note that on Dec 10, THTX announced a PDUFA goal date of Mar 25, 2025 for the new F8 formulation - meaning that in the worst case that the approval of the current Egrifta SV formulation delays, the new F8 formulation could take up the place by Mar 2025 assuming F8 obtains approval. One way or the other, we believe that the ongoing supply disruption of Egrifta should resolve early 2025 – then Egrifta should provide a solid stream of cash inflow while THTX is paving the way for the recently in-licensed Olezarsen and Donidalorsen, which in our understanding should provide the most significant growth in the upcoming years. We maintain our view that THTX’s stock is significantly discounted and investors should look at this as a buying opportunity. We are maintaining our SPECULATIVE BUY rating and US$3.80 TP.