01:55 PM EST, 12/18/2024 (MT Newswires) -- Theratechnologies ( THTX ) up 10.3% on last look, on Wednesday submitted a Prior Approval Supplement (PAS) to the U.S. Food & Drug Administration (FDA) describing changes made to the manufacturing environment of the facility where Egrifta SV is produced.

Egrifta SV production had resumed in early December, after a voluntary shutdown of the company's contract manufacturer's facility to address "observations" from an FDA inspection. Theratechnologies ( THTX ) reported that one newly manufactured batch of Egrifta SV, used to treat excess abdominal fat in HIV-infected adult patients with lipodystrophy, has completed standard quality control. However, it can only be distributed when the PAS is approved.

A PAS is reviewed by the FDA within four months of receipt. Current inventory levels of Egrifta SV are expected to meet patient demand until mid-January, Theratechnologies ( THTX ) said.

The company's shares were last seen up $0.24 to $2.57 on the Toronto Stock Exchange.

Price: 2.57, Change: +0.24, Percent Change: +10.30