Intercept Pharmaceuticals Inc - ICPT STOCK NEWS

Intercept Pharmaceuticals reported Q1 2023 financial results with net sales of $68.0 million, marking a 15% increase from the previous year. This growth is attributed to the strong market position of its drug Ocaliva, which continues to perform well in the Primary Biliary Cholangitis (PBC) segment. The company is preparing for a pivotal FDA Advisory Committee Meeting on May 19, 2023, to discuss the new drug application for OCA in treating pre-cirrhotic fibrosis due to NASH, with a target action date set for June 22, 2023. The firm also highlighted advancements in its combination therapy with bezafibrate, with ongoing clinical trials expected to yield more data later this year.

Intercept Pharmaceuticals (Nasdaq: ICPT) announced that seven abstracts related to primary biliary cholangitis (PBC) and nonalcoholic steatohepatitis (NASH) have been accepted for presentation at EASL 2023, taking place from June 21-24 in Vienna, Austria.

Among the abstracts, one features new data from a planned interim analysis of a Phase 2 study investigating the combination of obeticholic acid (OCA) and bezafibrate in PBC. The company is expected to complete interim analyses from two ongoing Phase 2 studies by the end of 2023 to prepare for a meeting with the FDA.

Intercept's leadership expresses optimism regarding the potential benefits of the OCA-bezafibrate combination therapy for PBC patients, highlighting its importance in their long-term strategy to enhance treatment.

Intercept Pharmaceuticals (Nasdaq: ICPT), a biopharmaceutical firm specializing in liver disease treatments, is set to release its Q1 2023 financial results on April 27, 2023. The announcement will include updates on the commercial launch strategy for obeticholic acid (OCA) targeting nonalcoholic steatohepatitis (NASH). Following this, a conference call will be held from 8:00 a.m. to 9:30 a.m. ET.

The company has submitted a New Drug Application (NDA) for accelerated approval of OCA for patients with pre-cirrhotic fibrosis due to NASH, with a PDUFA target action date of June 22, 2023.

Intercept Pharmaceuticals (Nasdaq: ICPT) announced an Advisory Committee Meeting on May 19, 2023, regarding its NDA for obeticholic acid (OCA) as a treatment for pre-cirrhotic liver fibrosis due to NASH. The PDUFA target action date is set for June 22, 2023. NASH, a significant liver disease with no approved treatments, leads to severe outcomes including liver failure. The ongoing REGENERATE study involves 2,480 participants and aims to assess OCA's efficacy and safety. The company underscores the critical need for effective therapies in NASH, given its alarming growth as a leading cause of liver transplants.

Intercept Pharmaceuticals, Inc. (Nasdaq: ICPT) announced its participation in the Barclays Global Healthcare Conference on March 14, 2023, at the Loews Miami Beach Hotel. This conference provides an opportunity for investors to engage with the Intercept management team, enhancing its visibility in the healthcare sector. Intercept focuses on innovative therapeutics for progressive non-viral liver diseases, including primary biliary cholangitis (PBC) and nonalcoholic steatohepatitis (NASH). The company encourages interested investors to connect for potential meetings with its management team.

Intercept Pharmaceuticals reported U.S. Ocaliva® net sales of $77.2 million for Q4 2022 and $285.7 million for the full year, marking growth of 13% and 10% respectively. Worldwide non-GAAP adjusted net sales reached $343.8 million for 2022. The company has $490.9 million in cash resources as of December 31, 2022. A PDUFA date is set for June 22, 2023, for OCA targeting pre-cirrhotic liver fibrosis due to NASH. The company resolved ongoing patent litigation, securing market exclusivity for Ocaliva into the 2030s. In 2023, Intercept anticipates Ocaliva net sales between $310 million and $340 million.

Intercept Pharmaceuticals (Nasdaq: ICPT) announced participation in Cowen’s 43rd Annual Health Care Conference, scheduled for March 7, 2023. CEO Jerry Durso and CFO Andrew Saik will host a fireside chat from 2:10 p.m. to 2:40 p.m. ET. A live audio webcast will be available, alongside an archive for 90 days on the company's investor site. Attendees wishing to meet the management team should contact their representative or reach out to Nareg Sagherian. Intercept focuses on developing therapeutics for progressive non-viral liver diseases such as primary biliary cholangitis and nonalcoholic steatohepatitis.

Intercept Pharmaceuticals (Nasdaq: ICPT) will announce its Q4 and full-year 2022 financial results on March 2, 2023, followed by a conference call at 8:30 a.m. ET. The company specializes in developing therapeutics for progressive non-viral liver diseases like primary biliary cholangitis (PBC) and nonalcoholic steatohepatitis (NASH). Investors can access the call through the company's investor page, and a replay will be available afterward.

Intercept Pharmaceuticals (Nasdaq: ICPT) announced that the FDA has accepted its New Drug Application (NDA) for obeticholic acid (OCA) to treat pre-cirrhotic liver fibrosis due to nonalcoholic steatohepatitis (NASH). The PDUFA target action date is set for June 22, 2023. The NDA is supported by data from the Phase 3 REGENERATE study, which showed that OCA 25 mg significantly improved liver fibrosis without worsening NASH compared to placebo. This therapy aims to address a significant unmet need, as there are currently no approved medications for NASH, a leading cause of liver transplantation in the U.S.