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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.

Rhea-AI Summary

Intercept Pharmaceuticals, a biopharmaceutical company, will present five abstracts on primary biliary cholangitis at Digestive Disease Week® 2024. Highlights include data from Phase 2 and Phase 3 trials evaluating obeticholic acid. The company aims to showcase its commitment to improving the lives of those with PBC and share insights with the scientific community.

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Intercept Pharmaceuticals announces FDA acceptance of sNDA for Ocaliva in treating primary biliary cholangitis, with a PDUFA target action date of October 15, 2024.
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Intercept Pharmaceuticals, Inc. (ICPT) - New data from Phase 2 studies show combination of OCA + bezafibrate achieved biochemical remission in 40-44% of PBC patients in the first 12 weeks. Results support progression to Phase 3 trials of sustained release formulation of bezafibrate with low doses of OCA.
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Intercept Pharmaceuticals, Inc. (ICPT) announces new data from a sub-analysis of the Phase 3 POISE trial evaluating the impact of obeticholic acid (OCA) on primary biliary cholangitis (PBC). The analysis suggests OCA’s potential to reduce GGT and ALP levels below thresholds that predict improved outcomes, to be presented at the American Association for the Study of Liver Diseases’ (AASLD) The Liver Meeting® in Boston on November 13, 2023.
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Alfasigma (ALFA) and Intercept Pharmaceuticals (ICPT) announced the completion of Alfasigma's acquisition of Intercept. The deal adds Ocaliva, an FDA-approved treatment for primary biliary cholangitis, to Alfasigma's portfolio, strengthening its presence in the US market. The acquisition also enhances Alfasigma's innovation and R&D pipeline, with the addition of a novel fixed-dose combination for PBC treatment.
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Alfasigma (NASDAQ: ICPT) has completed the tender offer to purchase all outstanding shares of Intercept Pharmaceuticals, Inc. at a price of USD 19.00 per share. 31,158,412 shares, representing approximately 74.5% of Intercept’s outstanding shares, were tendered and not withdrawn. Alfasigma expects to complete the acquisition on November 8, 2023, through a merger without a vote or meeting of Intercept’s stockholders.
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Alfasigma's proposed acquisition of Intercept Pharmaceuticals has passed the waiting period under the HSR Act. Other conditions still need to be satisfied for the tender offer to be completed. The offer and withdrawal rights will expire on November 8, 2023.
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Persephone Biosciences appoints Daniel Bradbury as Chair of the Board of Directors
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Alfasigma announces cash tender offer to purchase Intercept Pharmaceuticals shares.
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Alfasigma to acquire Intercept for $19.00 per share in cash, representing an 82% premium to Intercept's closing price on September 25, 2023. The acquisition will expand Alfasigma's portfolio in gastroenterology and hepatology and strengthen its presence in the U.S. market. Alfasigma adds Ocaliva®, generating $152 million in revenue in 1H 2023. Transaction expected to close by the end of 2023.
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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

ICPT Rankings

ICPT Stock Data

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