Theratechnologies Faces FDA Rejection for New HIV-Related Weight Imbalances Treatment

Theratechnologies, a biopharmaceutical company based in Montreal, experienced a significant drop in its U.S.-listed shares during premarket trading on Wednesday. The cause of this decline was the Food and Drug Administration's (FDA) rejection of Theratechnologies' application for approval of a new formulation of its HIV-related weight imbalances treatment.

The FDA has requested additional information from the company regarding immunogenicity and the chemistry, manufacturing, and controls of the F8 formulation of Egrifta. It is important to note that Egrifta is already approved in the U.S. for reducing excess abdominal fat in adults with HIV and lipodystrophy.

Theratechnologies has highlighted the advantages of the F8 formulation compared to the current formulation, marketed as Egrifta SV. These advantages include a higher concentration, allowing for a smaller volume of administration.

Following the announcement that the FDA had extended its review of the new formulation beyond the anticipated target action date, Theratechnologies' shares decreased by 7% on Tuesday. As of now, the company has stated its intention to address the FDA's requests and continue to pursue approval for the new formulation.

In premarket trading, Theratechnologies' shares experienced a further decline of 30%, falling from $1.72 to $1.20.

Overall, this rejection represents a setback for Theratechnologies as it seeks to introduce an improved treatment option for individuals with HIV-related weight imbalances.