TH Theratechnologies Inc

By Colin Kellaher

U.S.-listed shares of Theratechnologies tumbled in premarket trading Wednesday after the Food and Drug Administration turned away an application from the biopharmaceutical company seeking approval of a new formulation of its treatment for HIV-related weight imbalances.

The Montreal company said the FDA is seeking more information related to immunogenicity and about chemistry, manufacturing and controls for the F8 formulation of Egrifta, which is approved in the U.S. for the reduction of excess abdominal fat in adults with HIV and lipodystrophy.

Theratechnologies has said the F8 formulation has a number of advantages over the current formulation, marketed as Egrifta SV, including that it is two times more concentrated, resulting in a smaller volume of administration.

Theratechnologies shares fell 7% Tuesday after the company said the FDA had extended its review of the new formulation beyond Monday's target action date.

The company on Wednesday said it plans to address the FDA's request and continue to pursue approval of the new formulation.

Theratechnologies shares, which closed Tuesday at $1.72, were recently down 30% at $1.20 in premarket trading.

Write to Colin Kellaher at colin.kellaher@wsj.com

(END) Dow Jones Newswires

January 24, 2024 08:37 ET (13:37 GMT)

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