FDA delays action date for Theratechnologies

Theratechnologies (TSX:TH) expects to have an official response from the FDA in the fourth quarter this year about its new drug application for its tesamorelin, a treatment for excess abdominal fat in HIV-infected patients with lipodystrophy. The FDA had originally targeted July 27 to complete its review. “The FDA has indicated that the review is [...]

Theratechnologies riding wave of optimism

Shares of Theratechnologies (TSX:TH) jumped Friday after an FDA advisory committee on Thursday evening unanimously recommended the FDA green light the company’s tesamorelin drug to treat excess abdominal fat in HIV-infected patients with lipodystrophy, based on a favourable benefit-risk profile. The stock, which slumped earlier in the week after the committee’s briefing papers suggested Theratechnologies’ [...]

FDA committee clears Theratechnologies’ tesamorelin

An FDA advisory committee recommended by a 16-to-0 unanimous vote that Theratechnologies’ (TSX:TH) tesamorelin drug should be granted marketing approval by the FDA for the treatment of excess abdominal fat in HIV-infected patients with lipodystrophy, based on a favourable benefit-risk profile. “This recommendation reinforces our belief that the tesamorelin benefit-risk profile seen in clinical trials [...]

Theratechnologies presents combined Phase 3 results

Theratechnologies (TSX:TH)  presented pooled results from both its phase 3 clinical trials evaluating tesamorelin for the treatment of excess abdominal fat in HIV-infected patients with lipodystrophy at a conference in Germany. Treatments with two milligrams of tesamorelin daily for 26 weeks resulted in a significant decrease in visceral adipose tissue, no clinically significant changes in [...]