TH Theratechnologies Inc

By Robb M. Stewart and Colin Kellaher

Theratechnologies shares fell sharply at the opening bell after the Food and Drug Administration denied approval for a newer formulation of tesamorelin that the Canadian biopharmaceutical company proposed as a treatment to reduce excess abdominal fat in patients with HIV and lipodystrophy.

In early trading, the shares were 9.9% lower at C$2.10 in Toronto, and are trading down 60% over the last 12 months. On Nasdaq, the shares were 11% weaker at $1.53, for a drop over the last year of 61%.

In a complete response letter to the company's supplemental biologics license application, the FDA raised questions related to chemistry, manufacturing and controls concerning the microbiology, assays, impurities and stability for both a lyophilized product and the final reconstituted drug product, the company said. In addition, the FDA requested further information to understand the potential impact of the proposed formulation on immunogenicity risk.

Montreal-based Theratechnologies said it plans to address the FDA's request and intends to pursue approval of this newer formulation of tesamorelin. It also will continue to commercialize Egrifta SV, tesamorelin for injection, which is the only approved treatment in the U.S. for the reduction of excess abdominal fat in adults with HIV who have lipodystrophy.

Write to Robb M. Stewart at robb.stewart@wsj.com and Colin Kellaher at colin.kellaher@wsj.com

(END) Dow Jones Newswires

January 24, 2024 10:32 ET (15:32 GMT)

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