Detailed narrative
BRIUMVI Commercial Momentum
BRIUMVI achieved another record quarter of new patient starts, surpassing the prior record from Q1, and continues to demonstrate strong persistence. Physician adoption is expanding, with an increasing percentage of patients initiating treatment with BRIUMVI rather than switching later, which is seen as a strong indicator of long-term franchise strength.
The company is expanding its direct-to-consumer campaign to further drive long-term growth and aims to become the #1 prescribed anti-CD20 therapy in relapsing MS based on dynamic market share.
Simplified IV Dosing (ENHANCE Study)
Positive Phase III results from the ENHANCE study demonstrated that patients can initiate BRIUMVI with a single 600mg infusion, replacing the currently approved Day 1 and Day 15 initiation schedule. This simplified schedule, expected to be available as early as mid-next year, is anticipated to reduce treatment burden for patients and infusion centers, remove barriers to switching from other anti-CD20 therapies, and fuel additional share gains within the IV market.
Subcutaneous BRIUMVI Advancement
The company reported positive Phase I bioavailability data for its proprietary subcutaneous formulation of ublituximab, increasing confidence in a quarterly dosing schedule being evaluated in a fully enrolled Phase III study. Top-line Phase III results are expected around year-end or early next year.
A successful subcutaneous BRIUMVI product has the potential to materially expand the franchise's reach by competing in the self-administered therapy segment, which represents approximately 35% to 40% of the dynamic anti-CD20 market, effectively more than doubling BRIUMVI's current addressable market.
Pipeline Expansion Beyond MS
TG Therapeutics is extending BRIUMVI's reach into additional autoimmune-mediated diseases. Encouraging preliminary Phase I data in patients with myasthenia gravis (MG) led to the initiation of a registration-directed Phase II study. The company also initiated a Phase II study in treatment-resistant schizophrenia, exploring an underlying autoimmune component and utilizing biomarker analysis.
These efforts aim to leverage BRIUMVI's potential for durable disease control in new therapeutic areas.
Azer-cel Progress and Expansion
The allogeneic CD19 CAR-T program, azer-cel, continues to make encouraging progress, having enrolled more than 20 patients, primarily with progressive forms of multiple sclerosis. The study has been expanded to include additional B-cell-mediated diseases, specifically relapsing MS, MG, CIDP, and NMO. The company is looking forward to sharing a clinical update during the second half of the year, noting strong investigator enthusiasm and patient interest.
Capital Allocation Strategy
The company's capital allocation philosophy remains focused on creating the greatest long-term value. This includes prioritizing investments in BRIUMVI's commercial efforts, advancing the pipeline, and pursuing strategic business development opportunities that align with the long-term vision and generate attractive returns. Additionally, share repurchases will be considered when appropriate, with every decision guided by maximizing value per dollar invested.