Theratechnologies Resubmits Tesamorelin Application to FDA

Theratechnologies (TSE:TH) has released an update.

Theratechnologies has resubmitted a supplemental Biologics License Application to the FDA for its F8 formulation of tesamorelin, aiming to simplify dosing for HIV patients with excess abdominal fat. The company is addressing previous FDA concerns related to production and immunogenicity risks and expects a decision by March 2025. The new formulation is protected by U.S. patents until 2033.

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