TG Therapeutics (NASDAQ:TGTX) raised its 2026 revenue outlook after third-quarter sales of its multiple sclerosis treatment BRIUMVI climbed 52% in the United States, and executives said they expect a stronger fourth quarter.
The company now expects approximately $1 billion in total global revenue for the year, including projected payments from its international partner. It raised its U.S. BRIUMVI net product revenue forecast to $915 million to $920 million from $890 million to $905 million.
Third-quarter U.S. BRIUMVI revenue was $233 million, while total revenue rose 61% from a year earlier to approximately $260 million. Chief Commercial Officer Adam Waldman said the updated forecast implies more than $260 million in U.S. BRIUMVI revenue in the fourth quarter.
Sales Growth and Financial Results
Waldman said BRIUMVI recorded its 14th consecutive quarter of sequential U.S. revenue growth. New patient starts grew year over year and accelerated toward the end of the third quarter and into the fourth, he said. October was a record month for the number of BRIUMVI prescribers, while September and October were the product’s strongest hospital months since launch.
Patients who had not previously received treatment represented approximately 40% of new patient business, up from about 25% at launch, Waldman said. Roughly one-third of new patient starts continued to come from patients switching from another anti-CD20 therapy.
Chief Financial Officer Sean Power said third-quarter revenue included $7.4 million in product sales to international partner Neuraxpharm and $19.9 million in license, milestone, royalty and other revenue. The latter included a $10 million sales milestone from the partner.
Operating income increased to $86 million from $29 million a year earlier. Net income was $55.5 million, or $0.35 per diluted share. Power cautioned that the prior-year quarter included a substantial noncash income tax benefit that increased reported earnings.
The company ended September with approximately $557 million in cash, cash equivalents and investment securities. It repurchased $100 million of stock during the quarter. Full-year research and development and selling, general and administrative expenses, excluding stock-based compensation, are still expected to be $450 million to $500 million.
New Dosing Options in Development
TG Therapeutics is pursuing a simplified intravenous initiation regimen that would combine the currently approved day-one and day-15 doses into a single infusion. Chief Development Officer Hari Miskin said the phase 3b ENHANCE trial met its primary endpoint of demonstrating bioequivalence between the regimens.
Day-one infusion-related reactions occurred in 16% of patients receiving the single initiation dose, compared with approximately 26% under the standard regimen, Miskin said. There were no grade 3 or higher infusion-related reactions in either arm. The company is targeting a potential label update around mid-2027, subject to approval.
Chairman and CEO Michael Weiss said any sales benefit from the simplified regimen would likely emerge later in the second half of 2027, as treatment centers would need time to implement it. Waldman said the combined dose would not change BRIUMVI’s pricing.
The company is also developing a self-administered subcutaneous version intended for dosing every three months. Its phase 3 study is fully enrolled, with top-line results expected around year-end or early 2027. TG Therapeutics is targeting a potential 2028 launch and plans to use an auto-injector, Weiss said.
Weiss estimated that approximately 35% of new anti-CD20 treatment starts are for patients choosing self-administration, a segment BRIUMVI does not currently serve. He said the company expects the subcutaneous formulation, if approved, to complement rather than replace its intravenous business.
Long-Term and Early-Stage Data
At the ECTRIMS meeting, investigators presented seven-year follow-up data from the BRIUMVI ULTIMATE program. Among patients who completed seven years of continuous treatment, the annualized relapse rate was 0.018 and approximately 88% remained free of 24-week confirmed disability progression, Miskin said. He added that no new safety signals were observed.
The company also presented initial phase 1 results for azer-cel, an investigational CAR T-cell therapy for progressive multiple sclerosis. The dataset included 26 patients who had experienced disability progression despite high-efficacy treatment. Miskin said there were no dose-limiting toxicities, grade 3 or higher cytokine release syndrome, or grade 3 or higher infections.
At 90 days after treatment, nearly 90% of evaluable patients had stable or improved disability scores, Miskin said. He characterized the findings as preliminary and said the company would continue following patients and optimizing the dose.
Commercial and Policy Outlook
Asked about a competitor’s characterization of BRIUMVI’s contracting as aggressive and potentially unsustainable, Waldman said the company believes its approach is competitive and sustainable. He acknowledged ongoing pressure from payer mix, government discounts and other factors, and said price increases are used to help offset discounts and keep net pricing as stable as possible.
On expected changes to 340B pricing policy, Waldman estimated that Medicare patients at 340B hospitals account for about 5% of the company’s business. Based on what is known today, he said, TG Therapeutics expects minimal impact.
About TG Therapeutics (NASDAQ:TGTX)
TG Therapeutics is a biopharmaceutical company focused on developing and commercializing treatments for B-cell diseases, including autoimmune disorders and blood cancers. Its research has centered on therapies that target B cells, a type of immune cell involved in these conditions.
The company’s marketed product, BRIUMVI (ublituximab-xiiy), is an anti-CD20 monoclonal antibody approved in the United States to treat adults with relapsing forms of multiple sclerosis. TG Therapeutics also has investigated other drug candidates and combinations for immune-related and hematologic diseases.
Headquartered in New York, TG Therapeutics serves patients in the United States and has expanded BRIUMVI’s availability into international markets, including Europe.
