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Tricida, Inc., is a pharmaceutical company focused on the development and commercialization of its drug candidate, TRC101, a non-absorbed, orally-administered polymer designed to treat metabolic acidosis in patients with chronic kidney disease (CKD). Metabolic acidosis is a chronic condition commonly caused by CKD that is believed to accelerate the progression of CKD, increase the risk of muscle wasting and cause the loss of bone density. Tricida has successfully completed all of the clinical trials that it planned to complete prior to submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA), including a successful 135-subject, Phase 1/2 clinical trial (TRCA-101), a successful 217-subject, pivotal Phase 3 clinical trial (TRCA-301), and a successful 196-subject, Phase 3 extension trial (TRCA-301E). We plan to submit an NDA, in the second half of 2019, seeking approval of TRC101 through the FDA`s Accelerated Approval Program. Tricida was founded in August 2013 by a seasoned management team that has extensive experience in the development and commercialization of therapeutics, with substantial expertise in developing polymers for the treatment of kidney-related diseases. Tricida`s shared culture of teamwork, camaraderie and empowerment is evident in the dedication and focus our team demonstrates, with a commitment to the ultimate goal of improving and prolonging the lives of people living with CKD, and bringing critically needed new therapies to patients.
Rising Pharmaceuticals is an industry leader in marketing and distributing innovative branded and multi-source prescription and over-the-counter pharmaceutical products.
Madrigal Pharmaceuticals is a clinical-stage biopharmaceutical company pursuing novel therapeutics that target a specific thyroid hormone receptor pathway in the liver, which is a key regulatory mechanism common to a spectrum of cardio-metabolic and fatty liver diseases with high unmet medical need. The Company has advanced its lead candidate, resmetirom, also known as MGL-3196, a first-in-class, orally administered, small-molecule, liver-directed, thyroid hormone receptor (THR) β-selective agonist, through Phase 2 clinical trials in NASH. Primary and key secondary endpoints were achieved including reduction of liver fat on a sensitive non-invasive imaging test, lowering of multiple atherogenic lipids including LDL-cholesterol and triglycerides, and resolution of NASH on liver biopsy. Based on evidence of broad activity and a favorable safety profile, Madrigal has initiated a Phase 3 clinical study in NASH patients with advanced liver fibrosis, MAESTRO-NASH, in which the primary endpoint after one year of dosing is resolution of NASH and key secondary endpoints include LDL-cholesterol lowering and reduction in liver fibrosis. Clinical benefit in reducing progression to more advanced liver disease, including cirrhosis, is a long-term goal of this trial. A second Phase 3 clinical study, MAESTRO-NAFLD-1, has also been initiated. This 52-week non-invasive study in a broader segment of NASH patients will provide additional safety information to support the NASH indication and will include key efficacy endpoints: LDL-cholesterol lowering, triglyceride lowering, reduction of liver fat as determined by MRI-PDFF, as well as reduction of elevated liver enzymes and reduction in fibrosis biomarkers. This is a non-biopsy study in people with NASH, as documented using non-invasive techniques or historical liver biopsy.
Sandoz, a Division of the Novartis group, is a global leader in the field of generic pharmaceuticals, offering a wide array of high-quality, affordable products that are no longer protected by patents.
The Company is positioning itself to be one of the top three multi-state cannabis operators active in the U.S. legal cannabis and hemp sector. RWB is predominantly focusing its investments on the major US markets, including Michigan, Illinois, Massachusetts and California with respect to cannabis, and the US and internationally for hemp-based CBD products.