Retrophin, Inc. Provides Sales Guidance for the Fourth Quarter and Fiscal Year 2017; Provides General Update on its Development Programs
January 08, 2018 at 05:33 pm IST
Share
Retrophin, Inc. provides sales guidance for the fourth quarter and fiscal year 2017. The company announced that, based on preliminary and unaudited financial data, the company expects net product sales for the fourth quarter of 2017 to be approximately $42 million.
For the fiscal year 2017, the company expects total net product sales of approximately $155 million.
The company also provided a general update on its development programs, including anticipated milestones for 2018. The Phase 3 FORT Study of fosmetpantotenate continues to enroll patients with pantothenate kinase-associated neurodegeneration (PKAN) and is on-track to complete enrollment in the second half of 2018. Feasibility analyses and regulatory interaction for sparsentan in IgA nephropathy are underway with the expectation of initiating a clinical trial in 2018. CNSA-001 is expected to begin clinical development for phenylketonuria (PKU) in 2018 with results from a Phase 2 proof-of-concept study expected to be available in early 2019. The company expects a New Drug Application filing in 2018 for its new formulation of Thiola ® for the treatment of cystinuria, and anticipates marketing efforts to commence upon potential approval in 2019. In response to a U.S. Food and Drug Administration (FDA) request, the Company has conducted additional statistical analyses to support its Phase 3 trial design and eligibility for the Subpart H accelerated approval pathway for sparsentan in focal segmental glomerulosclerosis (FSGS). The Company will resubmit its Phase 3 protocol for FSGS during the first quarter of 2018.
Travere Therapeutics, Inc. is a biopharmaceutical company. The Company is focused on identifying, developing, and delivering life-changing therapies to people living with rare kidney and metabolic diseases. Its product, FILSPARI (sparsentan), is indicated to reduce proteinuria in adults with primary IgAN at risk of rapid disease progression. Sparsentan is also in late-stage development for focal segmental glomerulosclerosis (FSGS). The Companyâs Pegtibatinase is a novel investigational human enzyme replacement candidate being evaluated for the treatment of classical homocystinuria (HCU), which is a rare metabolic disorder. Its commercial products, Thiola and Thiola EC are for the treatment of cystinuria, a rare genetic cystine transport disorder that causes high cystine levels in the urine and the formation of recurring kidney stones. It is also engaged in the identification of potential small molecule therapeutics for Alagille syndrome (ALGS).
TRAVERE THERAPEUTICS, INC. 
