By Robb M. Stewart


Theratechnologies shares look set for a sharply lower start to the session after the Food and Drug Administration rejected a supplemental biologics license application for an intramuscular method of administering a maintenance dose of Trogarzo, a HIV-1 inhibitor.

In premarket trading on Nasdaq, the stock was 30% lower after ending the previous session at $1.64, up 1.2% so far in 2024. In Toronto, the shares last closed at C$2.20, up 2.8% in the new year.

The biopharmaceutical company said the FDA issued a refusal to file letter regarding the company's supplemental license application.

The FDA determined that the application wasn't sufficiently complete to permit a substantive review, Theratechnologies said. The refusal to file letter stated that the application didn't contain the data required to establish the pharmacokinetic bridge between the intramuscular and intravenous infusion route of administration of Trogarzo.

"While we are disappointed to receive this letter from the FDA, we were aware that the approval of this sBLA for Trogarzo IM administration could be challenging based on the results shared in October 2023 from the TMB-302 study, even though viral suppression was maintained throughout the study," said Christian Marsolais, chief medical officer at Theratechnologies. "We will now assess our options regarding this application."


Write to Robb M. Stewart at robb.stewart@wsj.com


(END) Dow Jones Newswires

02-27-24 0803ET