Summary
TG Therapeutics: Concerns About Slowing Growth And New Competition
TG Therapeutics continues strong execution with Briumvi, maintaining beat-and-raise performance and robust financials, including a new $100 million buyback program. However, high investor expectations, slowing growth of Briumvi and concerns about increased competition in the multiple sclerosis market have weighted on its share price. Novartis is testing a less frequently administered version of Kesimpta and Roche's fenebrutinib has generated positive phase 3 results in relapsing multiple sclerosis.
TG Therapeutics: Positives From Q3'25 Earnings, But Competitors Progressing
TGTX has seen rapid enrolment of the ENHANCE study which could allow a simplified dosing regime of IV Briumvi. A readout is possible for mid-2026. Investors may need to wait longer for the subcutaneous formulation of Briumvi to become available, with a readout from clinical work possible in late 2026 or early 2027. Kyverna Therapeutics's KYV-101 is emerging as a potential competitor to TGTX's Azer-cel in Multiple Sclerosis, although initial KYV-101 data is from a handful of patients.
TGTX's Q3 Earnings & Revenues Trump Estimates, 2025 View Raised
TG Therapeutics beats third-quarter estimates as a surge in Briumvi sales drives revenues up 92.8% and leads to a higher 2025 outlook.
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TG Therapeutics, Inc. Profile
| Biotechnology Industry | Healthcare Sector | Michael S. Weiss CEO | NASDAQ (CM) Exchange | 88322Q108 CUSIP |
| US Country | 352 Employees | - Last Dividend | 30 Apr 2012 Last Split | 14 Dec 1995 IPO Date |
Overview
TG Therapeutics, Inc. is a commercially operational biopharmaceutical entity dedicated to the identification, development, and dissemination of innovative treatments aimed at B-cell mediated diseases across both the United States and the global stage. Founded in 1993 and headquartered in Morrisville, North Carolina, TG Therapeutics has established itself as a pioneer in the field of autoimmune and hematological disorders. Through a combination of in-house R&D and strategic licensing or collaboration agreements with entities such as LFB Biotechnologies S.A.S, GTC Biotherapeutics, Ildong Pharmaceutical Co. Ltd., Rhizen Pharmaceuticals, Jiangsu Hengrui Medicine Co., Novimmune SA, and Checkpoint Therapeutics, Inc., the company has succeeded in creating a diverse portfolio of products and investigational medicines poised for commercial deployment and clinical exploration.
Products and Services
- BRIUMVI (anti-CD20 monoclonal antibody)
Approved for the treatment of adults with relapsing forms of multiple sclerosis (RMS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease. As an anti-CD20 monoclonal antibody, BRIUMVI represents a targeted therapeutic approach intended to alter the course of RMS by modulating the immune system's attack on the nervous system.
- Umbralisib (oral PI3K-delta inhibitor)
This oral therapy is focused on the treatment of adult patients with relapsed or refractory marginal zone lymphoma (MZL) and follicular lymphoma (FL). By inhibiting the PI3K-delta pathway, a critical component of B-cell receptor signaling in many blood cancers, umbralisib aims to halt the progression of these malignancies.
- TG-1701 (orally available BTK inhibitor)
TG-1701 is an innovative, orally administered Bruton's tyrosine kinase (BTK) inhibitor that showcases selectivity and potency against BTK in preclinical studies. Its development is aimed at treating a variety of B-cell malignancies by blocking a key signal that promotes cancer cell survival and proliferation.
- TG-1801 (bispecific CD47 and CD19 antibody)
This investigational bispecific antibody targets CD47 and CD19, two proteins involved in the immune evasion of cancer cells. By engaging both targets, TG-1801 is designed to promote the phagocytosis of cancer cells by the immune system, offering a novel approach for the treatment of hematological cancers.
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