The company's lead product is obeticholic acid, OCA, also known as 6-ethyl-chenodeoxycholic acid or INT-747, marketed as Ocaliva. OCA is a potent first-in-class farnesoid X receptor (FXR) agonist. As of March 2017, Ocaliva is approved in the US and the EU for use in primary biliary cholangitis. It is in phase III studies for non-alcoholic steatohepatitis (NASH) and phase II studies for primary sclerosing cholangitis.
Other products in the development pipeline include INT-767, a dual FXR/TGR5 agonist, and INT-777, a TGR5 agonist.
On June 29, 2020, the company released a statement announcing that FDA had rejected its lead product obeticholic acid, OCA, because FDA officials had determined that "the predicted benefit of the drug does not sufficiently outweigh the predicted risks".[3]
Initial public offering and stock historyedit
Intercept trades on the NASDAQ exchange under the ticker symbol ICPT. The initial public offering of the stock on October 16, 2012 was at $15.[4] A follow-on public offering at $33 took place on June 24, 2013.
On January 9, 2014, the stock skyrocketed from $72.39 to $275.49, or about 280%, after a planned interim analysis by the independent data safety monitoring board showed that Obeticholic acid met the main goal (improvement of liver histology) at the mid-stage in the FLINT trial in NASH, sponsored by NIDDK.[5][6] The stock continued to climb to $497 over the next few days before falling back to around $317 on March 29, 2014, giving a market capitalization of around $6.2 billion.
In March 2014, the company released the results of the POISE study of Obeticholic acid in PBC, which showed the drug met the trial's primary endpoint of a reduction in serum alkaline phosphatase, a biomarker for the disease.[7] These results were presented at an international liver meeting in April 2014.[8]
As of 31 December 2014, the company has 136 employees.[9]
In 2023, Intercept Pharmaceuticals was acquired by Italian Alfasigma S.p.A for $19.00 per share in cash (approximately $800 million).[10][11][12]
Referencesedit
^"Contact Us". Intercept Pharmaceuticals. Retrieved 13 April 2022.
^"Alfasigma to Acquire Intercept Pharmaceuticals for $19.00 per Share in Cash, Expanding the Global Footprint of Alfasigma Via a Leader in Rare and Serious Liver Diseases". Yahoo Finance. 2023-09-26. Retrieved 2023-09-26.
^"Madrigal Pursues $500M Public Offering with NASH Market Up for Grabs". On Tuesday, still reeling from the rejection and left with no other advanced assets, Intercept agreed to be acquired by Italian pharma Alfasigma S.p.A for $800 million.
intercept, pharmaceuticals, this, article, needs, additional, citations, verification, please, help, improve, this, article, adding, citations, reliable, sources, unsourced, material, challenged, removed, find, sources, news, newspapers, books, scholar, jstor,. This article needs additional citations for verification Please help improve this article by adding citations to reliable sources Unsourced material may be challenged and removed Find sources Intercept Pharmaceuticals news newspapers books scholar JSTOR October 2023 Learn how and when to remove this message 40 40 43 N 78 14 35 W 40 678631 N 78 243038 W 40 678631 78 243038 Intercept PharmaceuticalsTraded asNasdaq ICPT 2012 23 IndustryBiotechnologyFounded2002FateAcquired by AlfasigmaHeadquartersMorristown New Jersey United States 1 Key peopleJerome Durso President and CEO Paolo Fundaro Chairman of the Board of Directors Revenue 250 2 Million 2019 2 Websitewww wbr interceptpharma wbr com Intercept Pharmaceuticals Inc is an American biopharmaceutical company incorporated in 2002 focusing on the development of novel synthetic bile acid analogs to treat chronic liver diseases such as primary biliary cirrhosis PBC now called primary biliary cholangitis non alcoholic fatty liver disease or non alcoholic steatohepatitis NASH cirrhosis portal hypertension primary sclerosing cholangitis and also the intestinal disorder bile acid diarrhea Contents 1 Products 2 Initial public offering and stock history 3 References 4 External linksProducts editThe company s lead product is obeticholic acid OCA also known as 6 ethyl chenodeoxycholic acid or INT 747 marketed as Ocaliva OCA is a potent first in class farnesoid X receptor FXR agonist As of March 2017 Ocaliva is approved in the US and the EU for use in primary biliary cholangitis It is in phase III studies for non alcoholic steatohepatitis NASH and phase II studies for primary sclerosing cholangitis Other products in the development pipeline include INT 767 a dual FXR TGR5 agonist and INT 777 a TGR5 agonist On June 29 2020 the company released a statement announcing that FDA had rejected its lead product obeticholic acid OCA because FDA officials had determined that the predicted benefit of the drug does not sufficiently outweigh the predicted risks 3 Initial public offering and stock history editIntercept trades on the NASDAQ exchange under the ticker symbol ICPT The initial public offering of the stock on October 16 2012 was at 15 4 A follow on public offering at 33 took place on June 24 2013 On January 9 2014 the stock skyrocketed from 72 39 to 275 49 or about 280 after a planned interim analysis by the independent data safety monitoring board showed that Obeticholic acid met the main goal improvement of liver histology at the mid stage in the FLINT trial in NASH sponsored by NIDDK 5 6 The stock continued to climb to 497 over the next few days before falling back to around 317 on March 29 2014 giving a market capitalization of around 6 2 billion In March 2014 the company released the results of the POISE study of Obeticholic acid in PBC which showed the drug met the trial s primary endpoint of a reduction in serum alkaline phosphatase a biomarker for the disease 7 These results were presented at an international liver meeting in April 2014 8 As of 31 December 2014 the company has 136 employees 9 In 2023 Intercept Pharmaceuticals was acquired by Italian Alfasigma S p A for 19 00 per share in cash approximately 800 million 10 11 12 References edit Contact Us Intercept Pharmaceuticals Retrieved 13 April 2022 Intercept Pharmaceuticals Revenue 2011 2021 ICPT FDA rejects Intercept Pharma s drug for fatty liver disease 29 June 2020 Intercept Pharmaceuticals Strong Biopharmaceutical IPO Seeking Alpha October 14 2012 Retrieved 2014 03 21 The Farnesoid X Receptor FXR Ligand Obeticholic Acid in NASH Treatment Trial FLINT Archived from the original on 2014 01 10 Intercept Pharma Press release Intercept Announces NASH Primary Endpoint Met FLINT Trial Stopped Early for Efficacy Based on Highly Statistically Significant Improvement in Liver Histology Archived from the original on November 29 2014 Retrieved January 9 2014 Intercept Pharma Press release Intercept Announces Positive Pivotal Phase 3 POISE Trial Results Archived from the original on March 26 2014 Retrieved March 27 2014 Intercept s liver disease drug proves highly effective in study Reuters April 12 2014 Retrieved April 14 2014 Intercept Pharmaceuticals Form 10 k Annual report 2014 Retrieved October 2 2015 Alfasigma to Acquire Intercept Pharmaceuticals for 19 00 per Share in Cash Expanding the Global Footprint of Alfasigma Via a Leader in Rare and Serious Liver Diseases Yahoo Finance 2023 09 26 Retrieved 2023 09 26 Madrigal Pursues 500M Public Offering with NASH Market Up for Grabs On Tuesday still reeling from the rejection and left with no other advanced assets Intercept agreed to be acquired by Italian pharma Alfasigma S p A for 800 million Alfasigma completes acquisition of Intercept Pharmaceuticals Inc Yahoo Finance Retrieved 2024 01 07 External links editOfficial website nbsp Retrieved from https en wikipedia org w index php title Intercept Pharmaceuticals amp oldid 1194411980, wikipedia, wiki, book, books, library,
