Theratechnologies’ TH1902 receives FDA Fast Track Designation for the Treatment of Sortilin-Expressing Cancers

22 February 2021

Key Points

  • Theratechnologies recently announced that its TH1902 lead peptide conjugate received FDA Fast Track designation for the treatment of sortilin-expressing cancers.  
  • The Fast Track designation will facilitate the regulatory process as the drug moves to Phase 1 human trials.  Noteworthy also is the fact that the designation was granted after only animal trials, a fairly unusual move that highlights the potential of the TH1902  peptide.
  • Theratechnologies is also making progress on other fronts including continued growth in the marketing of its two existing drugs for HIV patients, Trogarzo and EGRIFTA, and entering Phase 3 trial for Tesamorelin F8 for the treatment of NASH.
  • The company is in a good financial position with over $70 million in cash and well positioned to continue financing its various initiatives.  2021 should be a fruitful year with continued growth of its marketed drugs and further pipeline progress.

Our Insights

The Opportunities

The continued growth of the company’s two HIV drugs, Trogarzo and EGRIFTA, is encouraging.  Drugs with similar growth and gross margin profiles are highly valued by the market, with typical transaction multiples ranging from 3x to 6x annual sales.  The company’s two pipeline initiatives are also significant value creation opportunities with strong results so far and large potential markets should either of the drugs receive FDA approval.

The Obstacles

The company needs to show continued positive momentum with its two approved drugs.  The regulatory process with the two pipeline candidates still has uncertainty despite the encouraging results so far; this effort also requires considerable financial investment from the company.