Theratechnologies shares lost 36% of their value Friday on the Toronto Stock Exchange after the Montreal biopharmaceutical company decided to review the design of its clinical trials of an agent for the treatment of cancerous tumors.
The news led the title of Theratechnologies to a new low of the last 52 weeks on the stock market.
Theratechnologies is pausing patient recruitment for its Phase I clinical trial of TH1902, its lead “investigational peptide-drug conjugate for the treatment of sortlin-expressing cancers”.
Management now plans to submit a modification to its protocol for approval by the United States Food and Drug Administration (FDA). The FDA last year granted the designation ” fast track at TH1902.
Theratechnologies maintains that it made its decision after consultation with its clinical researchers in order to review the design of the clinical trial.
The intent is to adjust the “dosing schedule” to allow for optimization of TH1902 delivery, i.e. lower doses at more frequent intervals.
The results obtained so far were not sufficiently convincing to pursue the recruitment of patients and did not outweigh the risk of adverse events observed in some patients, it is specified.
High risk
“We are disappointed, but we remain committed to advancing the technology of our SORT1+ technology platform and we will continue to study its potential in the treatment of advanced stage cancers”, commented in a press release Christian Marsolais, Senior Vice President and Chief from the medical department of Theratechnologies.
“Although this is a negative development, TH1902 is at a very early stage of development,” observes analyst Endri Leno of National Bank Financial. “Therefore, a rather high risk profile is associated with it. That’s why I don’t take it into account in my forecasts,” he adds.
The main question is why continue to invest in the development of such risky assets when energy, time and money could possibly be invested in other projects that potentially offer a better return on investment.
Endri Leno, analyst at National Bank Financial
His colleague Doug Loe, of the firm Leede Jones Gable, said he was not unduly surprised. “Although I was, and still am, optimistic, I was cautious about the non-linear path that was emerging to lead to phase III clinical trials,” he said in a note sent to his clients.
It is for this reason in particular that he did not yet assign a value to TH1902 in his calculations and that he does not intend to do so until there is a clear indication of a response in patients affected. of cancer. He does not rule out such a possibility after adjusting the doses for clinical trials. Adjusting the doses is also a “reasonable first step” to achieve this, he says.
His assessment of Theratechnologies’ stock continues to be linked to the commercial activities of the drug Trogarzo, a treatment for the human immunodeficiency virus (HIV), as well as the commercial activities of the main product sold by the company, c ie Egrifta, a drug to treat an effect of HIV.
Only two of the five analysts who officially follow Theratechnologies’ activities recommended buying the stock before the company’s most recent management decision.