Intercept Pharmaceuticals (Nasdaq: ICPT) announced new data demonstrating that obeticholic acid (OCA) significantly improves liver biochemistry and fibrosis in patients with nonalcoholic steatohepatitis (NASH) over two years. These results stem from the Phase 3 REGENERATE study, with OCA meeting its primary endpoint at 18 months. Notably, median liver stiffness improved to below the advanced fibrosis threshold. The drug's safety profile remained consistent, with pruritus as the most common adverse event. The findings were presented at the virtual International Liver Congress™ 2020, highlighting OCA's potential long-term benefits.
Intercept Pharmaceuticals (Nasdaq:ICPT) announced new findings from the Phase 3 REGENERATE study regarding obeticholic acid (OCA) for treating NASH patients. The data shows significant benefits in noninvasive liver fibrosis measures after 24 months of treatment. Additionally, long-term data from the open label extension of the Phase 3 POISE trial for primary biliary cholangitis (PBC) confirms OCA's safety and efficacy over six years. These results will be presented at the Digital International Liver Congress™ 2020, scheduled from August 27-29, 2020.
Intercept Pharmaceuticals reported net sales of $77.2 million for Ocaliva in Q2 2020, reflecting a 17% increase from the previous year. Total revenue reached $77.2 million, compared to $66.3 million in Q2 2019. The company adjusted its Ocaliva net sales guidance for 2020 to $300-$320 million and lowered non-GAAP adjusted operating expenses by $100 million to $460-$500 million. However, the FDA issued a Complete Response Letter regarding the NDA for OCA for NASH, delaying its expected launch.
Intercept Pharmaceuticals will release its Q2 2020 financial results before markets open on August 10, 2020. A conference call will follow at 8:30 a.m. ET, offering insights from management regarding the second quarter.
The call will be accessible via the company’s investor page or by phone. Intercept focuses on novel therapeutics for progressive non-viral liver diseases, specifically primary biliary cholangitis and nonalcoholic steatohepatitis.
Intercept Pharmaceuticals (Nasdaq: ICPT) announced that the FDA issued a Complete Response Letter (CRL) for the New Drug Application (NDA) of obeticholic acid (OCA) aimed at treating fibrosis due to nonalcoholic steatohepatitis (NASH). The FDA found the benefit-risk profile of OCA uncertain, recommending additional safety and efficacy data from the ongoing REGENERATE study. The NDA, based on 35 clinical trials involving 1,700 NASH patients, is pivotal as there are currently no approved therapies for this disease. The company plans to meet with the FDA to discuss the CRL.
Intercept Pharmaceuticals (Nasdaq: ICPT) announced a postponement of the FDA advisory committee meeting scheduled for June 9, 2020, regarding its NDA for obeticholic acid (OCA) to treat liver fibrosis due to NASH. The delay will allow for the review of additional data that the company plans to submit soon. This change means the FDA's review will likely extend past the PDUFA target action date of June 26, 2020. Intercept remains optimistic about its NDA submission, having previously received priority review and Breakthrough Therapy designation for OCA.
Intercept Pharmaceuticals (Nasdaq: ICPT) has announced that its President and CEO, Mark Pruzanski, will present at the Bank of America Merrill Lynch Virtual Global Healthcare Conference on May 13, 2020, at 2:20 p.m. ET. Investors can access a live webcast on the company’s investor page, with an audio archive available for two weeks post-event. Intercept focuses on developing therapeutics for progressive non-viral liver diseases, including primary biliary cholangitis and nonalcoholic steatohepatitis.