Theratechnologies resumes production of Egrifta SV

Theratechnologies (THTX) announced that the production of Egrifta SV has resumed following a voluntary shutdown of the company’s contract manufacturer’s facility to address observations from an inspection by the FDA. One newly manufactured batch of Egrifta SV has completed standard quality control and will be available for release to the market upon approval from the FDA of a prior approval supplement, which the company is expected to file around mid-December 2024. The manufacturing of two additional batches of Egrifta SV is currently underway. The company implemented measures to carefully manage existing inventory levels of Egrifta SV to meet patient demand until mid-January 2025. Theratechnologies continues to collaborate closely with the relevant divisions of the FDA and other key stakeholders to avoid a shortage at the patient level in 2025. The company will update the market on any further material developments.