Theratechnologies Faces Setback as FDA Denies Approval for Newer Formulation of Tesamorelin

By Robb M. Stewart and Colin Kellaher

Theratechnologies, a Canadian biopharmaceutical company, saw a significant drop in its shares as the Food and Drug Administration (FDA) rejected its proposal for a newer formulation of tesamorelin. The company had hoped to use this formulation as a treatment for reducing excess abdominal fat in HIV patients with lipodystrophy.

The shares of Theratechnologies opened 9.9% lower at C$2.10 in Toronto, reflecting a 60% decrease over the past year. On Nasdaq, the shares were down 11% at $1.53, resulting in a drop of 61% over the last year.

In response to the supplemental biologics license application submitted by Theratechnologies, the FDA issued a complete response letter. The letter addressed concerns regarding the chemistry, manufacturing, and controls of the proposed formulation, particularly in relation to microbiology, assays, impurities, and stability. Additionally, the FDA requested further information to evaluate the potential impact of the formulation on immunogenicity risk.

Theratechnologies, headquartered in Montreal, has stated its intention to address the FDA's concerns and continue seeking approval for the newer formulation of tesamorelin. In the meantime, the company will continue to focus on commercializing Egrifta SV, its existing approved treatment for excess abdominal fat reduction in HIV patients with lipodystrophy.