Theratechnologies (THTX) shares were up 50% in recent premarket activity Wednesday after the company said overnight that the US Food and Drug Administration approved its supplemental biologics license application for the new formulation of tesamorelin to be used as an injection.
The company said the tesamorelin injection is approved in the US for the reduction of excess abdominal fat in adults with HIV who have lipodystrophy.
The company plans to commercialize the new F8 formulation under the tradename EGRIFTA WR.
EGRIFTA WR only needs weekly reconstitution and requires less than half the administration volume as the current F4 formulation -- sold in the US as EGRIFTA SV -- which is reconstituted daily, the company said.
The new formulation, which is patent-protected in the US through 2033, will replace EGRIFTA SV.
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