TG Therapeutics, Inc. (NASDAQ: TGTX) announced that it has fully enrolled patients in a Phase 3 study of a subcutaneous formulation of its anti‑CD20 monoclonal antibody, BRIUMVI, for relapsing multiple sclerosis. The trial compares two self‑administered dosing schedules—every eight weeks and every twelve weeks—to the current twice‑annual intravenous regimen and is now ready to report topline results at the end of 2026 or in the first quarter of 2027.
The completion of enrollment positions TG Therapeutics to broaden BRIUMVI’s reach by offering a self‑administered, at‑home option. The company estimates that the subcutaneous formulation could capture 35‑40 % of the anti‑CD20 market that prefers subcutaneous therapy, thereby diversifying its revenue base beyond the existing IV product. This strategic shift aligns with a broader industry trend toward patient‑centric delivery methods and could enhance patient adherence and satisfaction.
Financially, TG Therapeutics has delivered strong growth in the past year. Total revenue reached $616.3 million in 2025, up from $329.0 million in 2024, driven largely by BRIUMVI sales. U.S. net product revenue for BRIUMVI in Q4 2025 was $182.7 million, a 20 % increase over Q3 2025 and a 92 % year‑over‑year rise. The company has reaffirmed its 2026 guidance, targeting total global revenue of approximately $875‑$900 million and BRIUMVI U.S. net product revenue of $825‑$850 million, reflecting confidence in the subcutaneous pipeline and continued demand for the IV product.
CEO Michael S. Weiss highlighted the milestone as a “significant step forward for our development program” and noted that the subcutaneous formulation “has the potential to significantly broaden our reach by offering patients greater flexibility, including a self‑administered at‑home option.” The company’s management views the enrollment completion as a key enabler for future commercialization and a lever to accelerate market penetration in the competitive anti‑CD20 landscape.
Analysts have maintained a strong‑buy consensus on TG Therapeutics, citing robust BRIUMVI growth and the upcoming subcutaneous launch as primary catalysts. The market reaction has focused on the company’s ability to capture a sizable share of the subcutaneous segment and on the financial upside implied by the expanded product offering.
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