TG Therapeutics (TGTX) 43rd Annual J.P. Morgan Healthcare Conference 2025 summary

Strategic focus and product overview

• Focused on B-cell mediated diseases with one approved drug, Briumvi, and two products in development, including a novel allogeneic CD19 CAR T for autoimmune diseases.

• Briumvi, a next-generation anti-CD20 monoclonal antibody for relapsing MS, was approved in December 2022 and is the main commercial product.

• Briumvi is commercialized in the U.S. and partnered for ex-North America rights, with launches in Germany and other countries.

• Patents for Briumvi extend through 2042, providing a long runway for franchise growth.

Market landscape and competitive differentiation

• CD20 monoclonal antibodies are the most prescribed class for relapsing MS, with Briumvi being the third to market.

• Briumvi offers a one-hour infusion twice yearly, compared to competitors' longer infusions, and is priced lower than competitors.

• Briumvi lacks a breast cancer risk warning, a key differentiator for female patients.

• Glycoengineering enhances efficacy and tolerability.

Clinical data and safety profile

• Phase 3 and five-year follow-up data from ULTIMATE I & II trials show sustained efficacy, with relapse rates as low as 0.02 at year 5 and a consistent safety profile with no new safety signals.

• Phase 3 trials showed relapse rates of 0.091 and 0.076, translating to one relapse every 11–13 years.