Tg Therapeutics, Inc. (NASDAQ: TGTX)

TG Therapeutics, Inc., a prominent player in the biopharmaceutical industry, is dedicated to the acquisition, development, and commercialization of innovative treatments for B-cell mediated diseases. The company's primary focus is the development and commercialization of its lead product, BRIUMVI (ublituximab-xiiy), an anti-CD20 monoclonal antibody approved for the treatment of relapsing forms of multiple sclerosis (RMS).

TG Therapeutics' main business activities encompass the development and commercialization of novel treatments, primarily centered around BRIUMVI. This product is the first and only anti-CD20 monoclonal antibody approved for the treatment of RMS, demonstrating significant efficacy in reducing the annualized relapse rate (ARR) and the number of new or enlarging T2 lesions in patients with RMS. The company has secured approval for BRIUMVI from the U.S. Food and Drug Administration (FDA), the European Commission (EC), and the Medicines and Healthcare products Regulatory Agency (MHRA) for its use in Europe and the United Kingdom, respectively.

The company's product pipeline extends beyond BRIUMVI, encompassing TG-1701, a novel, orally available Bruton's tyrosine kinase (BTK) inhibitor, and TG-1801, a potentially first-in-class, bispecific CD47 and CD19 antibody. Moreover, TG Therapeutics is evaluating Azercabtagene Zapreleucel (azer-cel), an allogeneic CD19 CAR T cell therapy program for autoimmune diseases and all other non-oncology indications.

TG Therapeutics holds a robust position within the industry, specializing in B-cell mediated diseases. The company's lead product, BRIUMVI, has proven effectiveness in reducing ARR and the number of new or enlarging T2 lesions in patients with RMS, securing approval from regulatory authorities in the United States and Europe. The company's pipeline of products in development, including TG-1701, TG-1801, and azer-cel, holds the potential to address significant unmet medical needs in the treatment of B-cell mediated diseases.

The company's customers include patients with RMS and other B-cell mediated diseases, as well as healthcare providers and payers. TG Therapeutics is deeply committed to patient care and support, offering a range of services and resources to facilitate patient access and management of their treatment.

TG Therapeutics' product portfolio includes:

* BRIUMVI: an anti-CD20 monoclonal antibody approved for the treatment of relapsing forms of multiple sclerosis (RMS)
* TG-1701: a novel, orally available Bruton's tyrosine kinase (BTK) inhibitor
* TG-1801: a potentially first-in-class, bispecific CD47 and CD19 antibody
* Azercabtagene Zapreleucel (azer-cel): an allogeneic CD19 CAR T cell therapy program for autoimmune diseases and all other non-oncology indications

TG Therapeutics has entered into licensing agreements with several partners, including LFB Biotechnologies, GTC Biotherapeutics, LFB/GTC LLC, Ildong Pharmaceutical Co. Ltd., Jiangsu Hengrui Medicine Co., Novimmune SA, and Precision. These partnerships provide the company with access to new technologies, expertise, and resources, enabling it to expand its product pipeline and commercialization efforts.

In the intensely competitive pharmaceutical and biotechnology industries, TG Therapeutics faces numerous established companies and new entrants vying for market share. To succeed, the company must identify novel and unique drugs or methods of treatment and complete their development ahead of competitors. The company relies on contract manufacturing relationships with Samsung Biologics and other third-party manufacturers to produce its commercial products. These manufacturers are subject to ongoing periodic and unannounced inspections by regulatory authorities to ensure compliance with current Good Manufacturing Practice (cGMP) regulations.

TG Therapeutics is subject to government and industry regulation, with numerous authorities imposing substantial regulations on the clinical development, manufacture, and marketing of its product candidates. The company must navigate the various pre- and post-approval requirements of regulatory agencies, including the FDA, EC, and MHRA, to obtain marketing authorization for its products. The company's sales will depend, in part, on the extent to which its products will be covered by third-party payors, such as government health programs, commercial insurance, and managed healthcare organizations. The company is also subject to healthcare reform measures, including the Affordable Care Act and the Inflation Reduction Act of 2022.