Corinne Jenkins's questions to TG Therapeutics Inc (TGTX) leadership • Q2 2025
Question
Corinne Jenkins requested details on the development of the subcutaneous BRIUMVI product, including the planned administration method (auto-injector or prefilled syringe) and the remaining work required on the device side for approval.
Answer
Chairman and CEO Michael Weiss explained that the pivotal trial will use a syringe from a vial to establish bioequivalence, followed by a bridging study to an auto-injector. He clarified that the company plans to use a standard, well-established auto-injector, and does not anticipate major technical challenges. The development work is factored into the existing timeline, which targets a BLA filing in 2027 and a potential launch in 2028.