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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 that its leadership team will present at the 2021 Cantor Virtual Global Healthcare Conference on September 28, 2021, at 8:40 a.m. ET. Presenters include Jerry Durso (CEO), M. Michelle Berrey (CMO), Linda Richardson (CCO), and Andrew Saik (CFO). A live webcast will be available on the investor page of Intercept's website, with an audio archive accessible for two weeks post-event. Intercept focuses on developing therapeutics for progressive non-viral liver diseases, notably primary biliary cholangitis and nonalcoholic steatohepatitis.

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Intercept Pharmaceuticals (Nasdaq: ICPT) has entered into agreements to repurchase $39.9 million of its 3.25% Convertible Senior Notes due 2023 for $38.1 million. This action reduces the 2023 Notes from $460 million to $113.7 million, effectively retiring over 75% of its debt obligations due in 2023. The CEO emphasized that these efforts strengthen their cash position and focus on business execution. The repurchase is subject to customary closing conditions and reflects Intercept's proactive approach to debt management to enhance shareholder value.

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Intercept Pharmaceuticals (Nasdaq: ICPT) announced that key executives, including Jerry Durso, M. Michelle Berrey, and Andrew Saik, will present at the Baird 2021 Global Healthcare Conference on September 14, 2021, at 10:15 a.m. ET. This virtual event will focus on novel therapeutics for progressive non-viral liver diseases. A live webcast will be accessible on Intercept's investor page, with an audio archive available for two weeks following the event.

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Intercept Pharmaceuticals (NASDAQ: ICPT) has announced a $500 million issuance of new Convertible Senior Secured Notes due 2026. The funds will integrate $306.5 million of 2023 Convertible Notes and $114.7 million of 2026 Convertible Notes, alongside a cash sale of $117.6 million in New Notes. A portion, approximately $75.7 million, will be utilized for stock buybacks at $16.75 per share to potentially bolster stock prices. Post-transaction, shares outstanding will decrease by 13.6%, enhancing shareholder value.

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Intercept Pharmaceuticals reported net sales of $96.6 million for Q2 2021, marking a 25% increase year-over-year. The company reiterated its full-year Ocaliva net sales guidance of $325 million to $340 million and non-GAAP adjusted operating expense guidance of $380 million to $410 million. The company achieved its first cash positive quarter and has made progress in its NASH fibrosis program, anticipating a pre-submission meeting with the FDA in H1 2022. The company's net loss decreased to $11.1 million, compared to $63.3 million in Q2 2020.

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Intercept Pharmaceuticals, Inc. (Nasdaq: ICPT) will disclose its second quarter 2021 financial results on July 29, 2021, before market open. This will be followed by a conference call at 8:30 a.m. ET to discuss the results. The call can be accessed through the investor section of the company's website or via phone. Intercept focuses on developing treatments for progressive non-viral liver diseases, including PBC and NASH, and has operations across the U.S., Europe, and Canada.

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Intercept Pharmaceuticals (Nasdaq: ICPT) announced new analyses from the Phase 3 REGENERATE study, highlighting the relationship between early reductions of aminotransferases and fibrosis improvement in NASH patients treated with obeticholic acid (OCA). Real-world data also showed that Ocaliva® effectively reduced alkaline phosphatase and bilirubin in primary biliary cholangitis (PBC) patients. These findings will be presented at the Digital International Liver Congress 2021 from June 23-26, providing insights into treatment responses and the natural history of PBC and NASH.

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Intercept Pharmaceuticals (Nasdaq:ICPT) announced that Jerry Durso, President and CEO, will present at the Raymond James 2021 Human Health Innovation Conference on June 22, 2021, at 1:20 p.m. ET. A live webcast will be accessible on the investor page of Intercept's website, 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. Founded in 2002, the company operates in the U.S., Europe, and Canada.

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Intercept Pharmaceuticals has appointed M. Michelle Berrey, M.D., M.P.H., as the new President of Research & Development and Chief Medical Officer. Her extensive experience includes leadership roles at Chimerix and Pharmasset, where she contributed to significant drug developments. The company is currently focused on expanding its PBC business and advancing regulatory dialogues for its NASH program. The transition comes as Intercept aims to enhance its pipeline and build on its established legacy in liver disease treatment.

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Intercept Pharmaceuticals, Inc. (Nasdaq: ICPT) announced the appointment of Andrew Saik as Chief Financial Officer. With over 20 years of biopharma finance experience, Saik previously served as CFO at Vyne Therapeutics, where he raised over $135 million. His extensive background includes leadership roles at PDS Biotechnology and Auxilium Pharmaceuticals. CEO Jerry Durso welcomed him during this pivotal time for Intercept, emphasizing Saik's ability to strengthen the company’s financial strategy and growth potential. Rocco Venezia served as Acting CFO prior to Saik’s appointment.

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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