Theratechnologies tumbles as FDA issues CRL on tesamorelin sBLA

The US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) in response to the supplemental Biologics License Application (sBLA) for the F8 formulation of tesamorelin, submitted by Montreal, Canada-based Theratechnologies (TSX: TH).

The news sent Theratechnologies’ shares down 7% on Tuesday and a further 30% to $1.20 in pre-market trading yesterday.

The company will address the FDA’s request and intends to pursue approval of this newer formulation of tesamorelin. The active ingredient is approved and marketed under the trade name Egrifta for the treatment of HIV patients with lipodystrophy.