04:46 PM EST, 12/03/2024 (MT Newswires) -- Theratechnologies ( THTX ) , a biopharmaceutical company, after close Tuesday said 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 U.S. Food and Drug Administration (FDA).
One newly manufactured batch of EGRIFTA SV, used to treat excess abdominal fat in HIV-infected adult patients with lipodystrophy, 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.
The manufacturing of two additional batches of EGRIFTA SV is currently underway, and the company has implemented measures to carefully manage existing inventory levels of the drug to meet patient demand until mid-January.
The company's shares closed up $0.03 to $1.85 on the Toronto Stock Exchange.