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Intercept Pharmaceuticals reported non-GAAP adjusted net sales of $100.4 million for Ocaliva in the second quarter of 2022, a 5% increase year-over-year. U.S. net sales were $71.8 million, up from $68.2 million in the same period last year. The company reissued its financial guidance for 2022, now projecting adjusted net sales between $325 million to $345 million and operating expenses of $335 million to $365 million. Intercept also plans to resubmit its NDA for NASH by the end of 2022 after a productive meeting with the FDA.
Intercept Pharmaceuticals (Nasdaq: ICPT) will announce its second quarter 2022 financial results before market open on August 3, 2022. Following the announcement, a conference call will be held at 8:30 a.m. ET to discuss the results. Investors can access the live webcast via the company's investor page. During the event, participants are encouraged to join 10 minutes early. A replay will be available shortly after the call and will remain accessible for a year.
Intercept Pharmaceuticals (ICPT) announced positive topline results from its pivotal Phase 3 REGENERATE trial of OCA for liver fibrosis due to NASH. The interim analysis showed that 22.4% of patients on OCA 25 mg achieved fibrosis improvement at 18 months, compared to 9.6% on placebo (p0.0001). This analysis, based on 931 subjects, confirmed the drug's efficacy, aligning with previous findings. The safety database included 2,477 patients, and the company plans to resubmit its New Drug Application (NDA) to the FDA shortly.
Intercept Pharmaceuticals (Nasdaq: ICPT) has finalized its transaction with Advanz Pharma, originally announced on May 5, 2022. The deal involves an upfront payment of $405 million, with an additional $45 million contingent on orphan drug exclusivity extensions from regulatory bodies. Intercept's international commercial operations will now be managed by Advanz. Future royalties on ex-U.S. sales of obeticholic acid for nonalcoholic steatohepatitis (NASH) are also expected. The company plans to provide updated financial guidance in its 2Q 2022 earnings report.
Intercept Pharmaceuticals (Nasdaq: ICPT) announced multiple abstracts showcasing the efficacy of obeticholic acid (OCA) for primary biliary cholangitis (PBC) at the International Liver Congress 2022 in London, taking place from June 22-26, 2022. The data will discuss real-world outcomes and predictive analyses related to liver health in PBC patients. Highlights include a study demonstrating improved survival rates for patients on OCA compared to controls, contributing to the evidence supporting OCA’s role in enhancing transplant-free survival rates in PBC care.
Intercept Pharmaceuticals (Nasdaq: ICPT) updated the timing for its pre-submission meeting with the FDA regarding the potential resubmission of its NASH NDA. Originally set for June, the meeting has been moved to July due to the FDA's request for topline data from the REGENERATE trial in advance. Intercept expects to release this topline data to the public in July, which may be pivotal in addressing the FDA's concerns from the previous complete response letter.
Intercept Pharmaceuticals reported findings from two studies evaluating Ocaliva for primary biliary cholangitis (PBC). The COBALT study, a Phase 3b/4 trial, was terminated early as it did not show a significant clinical benefit compared to placebo. In contrast, the HEROES-US study revealed that Ocaliva significantly improved event-free survival in PBC patients. Intercept plans to submit data from these studies to the FDA in support of post-marketing requirements.
Intercept Pharmaceuticals (Nasdaq: ICPT) has initiated a Phase 2 trial for a fixed-dose combination therapy using obeticholic acid (OCA) and bezafibrate (BZF) to treat patients with primary biliary cholangitis (PBC) who have not responded adequately to traditional treatments. This double-blind study aims to reduce alkaline phosphatase (ALP) levels over 12 weeks and will include approximately 60 patients mainly in the U.S. The combination therapy is expected to leverage the synergistic effects of both drugs in improving patient outcomes.
Intercept Pharmaceuticals reported net sales of Ocaliva® at $88.6 million for Q1 2022, marking an 8% growth from last year. The company is nearing completion of data analyses from Phase 3 REGENERATE and anticipates topline results from the REVERSE study in Q3. Advanz Pharma plans to acquire Ocaliva® for up to $450 million, enhancing Intercept's financial position. Operating expenses declined to $98.9 million, with a net loss of $17.3 million, a significant reduction from last year's $40.4 million loss. Cash reserves stood at $406.9 million.
Intercept Pharmaceuticals (Nasdaq:ICPT) has entered a $405 million agreement with Advanz Pharma concerning the commercialization of Ocaliva® (obeticholic acid) for primary biliary cholangitis (PBC) outside the U.S. This deal strengthens Intercept's balance sheet and allows further investment in its U.S. operations, including potential developments in nonalcoholic steatohepatitis (NASH). The agreement includes a $45 million contingent payment and future royalties on net sales of obeticholic acid for NASH. The transaction is expected to close within three months, subject to regulatory conditions.