Theratechnologies FDA Rejection

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Theratechnologies is poised for a significant setback as the Food and Drug Administration (FDA) has rejected its supplemental biologics license application for an intramuscular method of administering a maintenance dose of Trogarzo, an HIV-1 inhibitor.

Stock Performance

In premarket trading on Nasdaq, Theratechnologies shares were down by 30%, following a 1.2% increase in 2024, closing at $1.64 in the previous session. Similarly, in Toronto, the shares closed at C$2.20, reflecting a 2.8% gain in the new year.

FDA’s Decision

The biopharmaceutical company received a refusal to file letter from the FDA regarding its supplemental license application. The FDA cited that the application lacked completeness for a substantive review. Particularly, it mentioned the absence of essential data required to establish the pharmacokinetic bridge between the intramuscular and intravenous infusion route of administration of Trogarzo.

Company Response

Commenting on the FDA’s decision, Christian Marsolais, Theratechnologies’ chief medical officer, expressed disappointment but acknowledged the challenges based on the TMB-302 study results from October 2023. He stated, “We will now assess our options regarding this application.”

Theratechnologies now faces uncertainties concerning the future of its sBLA for Trogarzo’s intramuscular administration.

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