Theratechnologies falls on FDA briefing documents

Theratechnologies Inc. (TSX:TH) fell C$2.28 (52%) to C$2.09 on Tuesday after FDA questioned the risk-benefit profile of Egrifta tesamorelin in briefing documents posted ahead of Thursday's meeting to discuss the analog of growth hormone releasing factor to treat excess abdominal fat in HIV patients with lipodystrophy. The documents noted that it appears long-term therapy with Egrifta will be necessary because data show its effect on visceral adipose tissue (VAT) is not sustained after treatment is discontinued. Furthermore, FDA reviewers asserted there was a statistically significant increase in the number of patients with diabetes in the tesamorelin group relative to placebo and an increase in the serum insulin-like growth factor-1 ( IGF-1) values above the upper range of normal in a "considerable number" of Egrifta-treated patients. ...