Company: Tricida, Inc.
Symbol: TCDA
Description: Their goal is to slow the progression of chronic kidney disease, or CKD, through the treatment of metabolic acidosis.
Trade Date: 6/28
Shares: 10.3 million
Price Range: $16.00-$18.00
Underwriter(s): Goldman Sachs, J.P. Morgan, Cowen
Terms Added: 6-18-18
Business: They are a late-stage pharmaceutical company focused on the development and commercialization of their drug candidate, TRC101, a non-absorbed polymer designed to treat metabolic acidosis by binding and removing acid from the gastrointestinal tract, or GI tract. They recently completed their double-blind, placebo-controlled, pivotal Phase 3 clinical trial, TRCA-301, in 217 CKD patients with metabolic acidosis. The TRCA-301 trial met both its primary and secondary endpoints in a highly statistically significant manner (p < 0.0001 for all primary and secondary endpoints). TRC101 was well tolerated in their TRCA-301 trial. Both active (124 subjects) and placebo groups (93 subjects) had low discontinuation rates and low rates of treatment-related adverse events. One hundred ninety-six of the 208 eligible subjects who completed the 12-week treatment period in their pivotal TRCA-301 trial agreed to continue into their 40-week blinded safety extension trial, TRCA-301E, which they expect to complete in the first half of 2019. They plan to submit a New Drug Application, or NDA, in the second half of 2019, seeking approval of TRC101 through the U.S. Food and Drug Administration’s, or FDA’s, Accelerated Approval Program. The FDA may grant accelerated approval to a product for a serious or life-threatening disease or condition that provides meaningful therapeutic advantage to patients over existing treatments based upon a determination that the product has an effect on a surrogate endpoint that is reasonably likely to predict clinical benefit. Metabolic acidosis is a chronic condition commonly caused by CKD and is believed to accelerate the progression of kidney deterioration. Today, there are no chronic therapies for treating metabolic acidosis approved by the FDA. They believe TRC101, an in-house discovered, new chemical entity, may be an effective treatment for metabolic acidosis and slow the progression of kidney disease in CKD patients affected by metabolic acidosis.
Insider Buying:Certain of their existing stockholders and their affiliated entities have indicated an interest in purchasing an aggregate of approximately $45 million in shares of their common stock in this offering at the initial public offering price and on the same terms and conditions as the other purchasers in this offering.
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