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Intercept Pharmaceuticals, Inc. - ICPT STOCK NEWS

Welcome to our dedicated page for Intercept Pharmaceuticals news (Ticker: ICPT), a resource for investors and traders seeking the latest updates and insights on Intercept Pharmaceuticals stock.

Intercept Pharmaceuticals, Inc. (ICPT) is a leading biopharmaceutical company dedicated to the development and commercialization of innovative therapeutics aimed at treating progressive, non-viral liver diseases. Intercept's core focus is primarily on conditions such as primary biliary cholangitis (PBC), nonalcoholic steatohepatitis (NASH), primary sclerosing cholangitis (PSC), and biliary atresia. With its headquarters in New York and additional offices in San Diego, London, and Perugia, Intercept is well-positioned globally to drive forward its ambitious healthcare initiatives.

The company's flagship product, Ocaliva® (obeticholic acid), is a farnesoid X receptor (FXR) agonist, approved for the treatment of adults with PBC, either in combination with ursodeoxycholic acid (UDCA) for those with an inadequate response to UDCA or as monotherapy for patients who cannot tolerate UDCA. The recent developments include a landmark Phase 3 POISE trial revealing significant impacts on key biomarkers for PBC treatment, demonstrating Ocaliva's potential to not only reduce gamma-glutamyl transferase (GGT) and alkaline phosphatase (ALP) levels but also improve clinical outcomes.

In addition, Intercept is actively engaged in advancing the investigational combination of OCA and bezafibrate, shown in Phase 2 studies to affect multiple key serum biomarkers predictive of clinical outcomes. This combination therapy targets both FXR and peroxisome proliferator-activated receptor (PPAR) pathways, offering potential enhanced therapeutic benefits.

Financially stable, Intercept continues to invest significantly in R&D, highlighted by recent presentations at the American Association for the Study of Liver Diseases (AASLD) and Digestive Disease Week® (DDW). As of February 2024, the FDA has accepted a supplemental New Drug Application (sNDA) for Ocaliva, further solidifying its position in the liver disease treatment market. Intercept remains committed to improving patient outcomes and enhancing the quality of life for those affected by these serious conditions.

For the most current news and developments, visit the Intercept Pharmaceuticals website or follow their updates on LinkedIn and Twitter.

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Intercept Pharmaceuticals (Nasdaq: ICPT) announced multiple abstracts for presentation at The Liver Meeting® 2022, highlighting the benefit-risk profile of obeticholic acid (OCA) for liver fibrosis due to NASH. Key data from the REGENERATE study, demonstrating improved clinical outcomes, including transplant-free survival in PBC patients treated with OCA, will be featured. Additionally, new findings on INT-787, a next-generation FXR agonist, will also be presented. The meeting will take place in Washington, D.C., from November 4 to 8, 2022.

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Intercept Pharmaceuticals (Nasdaq: ICPT) will release its Q3 2022 financial results on November 1, 2022, prior to market opening. A conference call and audio webcast will follow at 8:30 a.m. ET. Investors can join via the company’s investor page, and questions can be submitted in advance for participation.

Intercept focuses on developing therapeutics for non-viral liver diseases, such as primary biliary cholangitis and nonalcoholic steatohepatitis. For more details, visit their official website.

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Intercept Pharmaceuticals (Nasdaq: ICPT) announced that Jerry Durso, CEO, and Dr. Michelle Berrey, President of R&D, will participate in a fireside chat at H.C. Wainwright's 6th Annual NASH Investor Conference on October 17, 2022. The chat is scheduled from 2:30 p.m. to 3:00 p.m. ET. Investors interested in attending can register for the conference. The company focuses on developing novel therapies for progressive non-viral liver diseases, including primary biliary cholangitis and nonalcoholic steatohepatitis.

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Intercept Pharmaceuticals announced it is set to resubmit its new drug application (NDA) for OCA, targeting liver fibrosis due to nonalcoholic steatohepatitis (NASH) by year-end, following encouraging results from the Phase 3 REGENERATE study. However, the REVERSE study, which investigated OCA in patients with compensated cirrhosis, did not meet its primary endpoint, showing histological improvement in fibrosis. Treatment was generally safe, with no new safety signals detected despite a higher incidence of pruritus and gallstones. Overall, the company remains optimistic about OCA's future in treating liver fibrosis.

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Intercept Pharmaceuticals (Nasdaq: ICPT) has successfully reduced its outstanding debt by 54% or $388.9 million, bringing total debt down to $336.3 million. Additionally, the company decreased its annual cash interest expense by 58% to $9.8 million. These measures, including a private repurchase of senior secured convertible notes and the sale of its international business, enhance Intercept's capital structure and position it for growth in its PBC franchise and progress in its NASH program. The company’s cash position exceeds $500 million, creating a net debt positive situation for the first time since 2019.

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Intercept Pharmaceuticals announced a significant study published in Gastroenterology showing that patients receiving OCA for primary biliary cholangitis (PBC) experience better transplant-free survival than those not treated with OCA. Key findings indicate a 70% lower risk of death or liver transplant for OCA patients. The study compared data from the Phase 3 POISE trial with real-world registries, providing evidence of OCA's clinical efficacy. The research is seen as a pivotal development in evaluating treatments for PBC.

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Intercept Pharmaceuticals (Nasdaq: ICPT) announced participation in investor conferences with CEO Jerry Durso and CFO Andrew Saik. The events include the H.C. Wainwright 24th Annual Global Investment Conference on September 13, 2022, and the Baird Global Healthcare Conference on September 14, 2022. Both fireside chats will be accessible via Intercept's investor page. The company focuses on developing therapies for progressive non-viral liver diseases, including primary biliary cholangitis (PBC) and nonalcoholic steatohepatitis (NASH).

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Intercept Pharmaceuticals (Nasdaq: ICPT) will participate in investor meetings at the Citi 17th Annual BioPharma Conference on September 8, 2022, in Boston. This event focuses on the development of therapeutics for progressive non-viral liver diseases, including primary biliary cholangitis and nonalcoholic steatohepatitis. Investors interested in meeting with the management team can contact Nareg Sagherian to check availability. For more details, visit www.interceptpharma.com.

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Intercept Pharmaceuticals (Nasdaq: ICPT) announced a strategic repurchase of $327.9 million of its secured convertible debt, reducing total outstanding debt by 45%. This move aims to improve capital structure and limit potential shareholder dilution by 6.3 million shares. The repurchase involves 222.0 million in cash and 9.4 million shares for its 3.50% Convertible Senior Secured Notes due 2026. Post-transaction, the principal balance will decrease to 172.1 million, resulting in annual interest savings of 11.5 million. Intercept's cash position will exceed 500 million.

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Intercept Pharmaceuticals (Nasdaq: ICPT) will participate in B. Riley’s virtual PBC Mini Symposium on August 24, 2022. The event, titled Orphan Liver Disease That May Not Be As Rare As You’d Think, will feature discussions on the adoption and use of PBC therapies by industry leaders and physicians. Intercept's fireside chat is scheduled for 1:00 p.m. ET. The event will start at 11:00 a.m. ET and will be webcast live. For more details, visit Intercept's investor page.

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FAQ

What is the market cap of Intercept Pharmaceuticals (ICPT)?

The market cap of Intercept Pharmaceuticals (ICPT) is approximately 794.7M.

What does Intercept Pharmaceuticals, Inc. specialize in?

Intercept Pharmaceuticals, Inc. specializes in the development and commercialization of novel therapeutics to treat progressive, non-viral liver diseases such as primary biliary cholangitis (PBC), nonalcoholic steatohepatitis (NASH), primary sclerosing cholangitis (PSC), and biliary atresia.

What is Ocaliva® (obeticholic acid)?

Ocaliva® (obeticholic acid) is a farnesoid X receptor (FXR) agonist used to treat adults with primary biliary cholangitis (PBC). It can be used in combination with ursodeoxycholic acid (UDCA) for those who have an inadequate response to UDCA or as a monotherapy for those who cannot tolerate UDCA.

Where are Intercept Pharmaceuticals’ offices located?

Intercept Pharmaceuticals’ corporate headquarters are in New York, with additional offices in San Diego, London, and Perugia.

What are the recent developments at Intercept Pharmaceuticals?

Recent developments include Phase 3 POISE trial results demonstrating Ocaliva's potential in improving key biomarkers for PBC treatment and Phase 2 studies exploring the therapeutic benefits of combining OCA with bezafibrate. The FDA also accepted a supplemental New Drug Application (sNDA) for Ocaliva in February 2024.

How does Intercept Pharmaceuticals contribute to liver disease treatment?

Intercept Pharmaceuticals contributes to liver disease treatment through innovative drug development, including Ocaliva® for PBC and investigational combinations like OCA and bezafibrate, targeting progressive non-viral liver diseases and aiming to improve patient outcomes.

What is the significance of the POISE trial?

The POISE trial is significant as it demonstrated Ocaliva's potential to reduce key biomarkers like gamma-glutamyl transferase (GGT) and alkaline phosphatase (ALP) in PBC patients, potentially improving clinical outcomes and survival rates.

What is the investigational combination of OCA and bezafibrate?

The investigational combination of OCA and bezafibrate targets both FXR and peroxisome proliferator-activated receptor (PPAR) pathways, showing potential to enhance therapeutic benefits for PBC patients as evidenced by Phase 2 studies.

How does Intercept Pharmaceuticals stay committed to its mission?

Intercept Pharmaceuticals stays committed to its mission by continuously investing in research and development, presenting new findings in scientific forums, and seeking regulatory approvals to bring innovative treatments to patients with serious liver diseases.

What are the safety concerns associated with Ocaliva?

Ocaliva carries a boxed warning for hepatic decompensation and failure in PBC patients with cirrhosis. Routine monitoring for liver function and potential adverse reactions, including severe pruritus and reduced HDL-C levels, is necessary during treatment.

Where can I find more information about Intercept Pharmaceuticals?

For more information about Intercept Pharmaceuticals, you can visit their website at www.interceptpharma.com or follow their updates on LinkedIn and Twitter.

Intercept Pharmaceuticals, Inc.

Nasdaq:ICPT

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ICPT Stock Data

794.69M
40.45M
3.13%
81.3%
24.24%
Biotechnology
Healthcare
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United States
Morristown