Theratechnologies' shares dropped 30% as FDA refused to file a supplemental biologics license application for Trogarzo due to insufficient data.
Theratechnologies' shares dropped 30% after the FDA refused to file a supplemental biologics license application for an intramuscular method of administering Trogarzo, a HIV-1 inhibitor. The FDA deemed the application insufficiently complete, as it lacked the necessary data to establish a pharmacokinetic bridge. Theratechnologies will now assess their options regarding the application.
February 27, 2024
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