Intercept Pharma

Intercept Pharmaceuticals, Inc. operates as a biopharmaceutical company. The firm engages in the research, development, and commercialization of novel therapeutics in treating chronic liver diseases. Its product pipeline includes OCALIVA, which is used for the treatment of biliary cholangitis, nonalcoholic steatohepatitis, sclerosing cholangitis and biliary atresia. The company was founded by Mark E. Pruzanski and Roberto Pellicciari on September 4, 2002 and is headquartered in Morristown, NJ.

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Earnings data Q3 2024

Intercept Pharma reports robust earnings, eyes growth amid competitive challenges

Intercept Pharma's Q4 2022 earnings call highlighted strong financial performance, strategic advancements, and a focus on innovation and market expansion.
The company's achievements in sales growth, patent protection, and financial stability position it well for future growth and leadership in the PBC and NASH markets.
Challenges in competitive dynamics and regulatory landscape require proactive strategies, while opportunities in new programs and market developments offer avenues for continued success.
Overall, Intercept Pharma's performance underscores a resilient and forward-thinking approach to navigating the complexities of the pharmaceutical industry and driving sustainable growth.

Intercept Pharma reports growth in sales and navigates NASH landscape

Intercept Pharma's Q1 2023 performance saw growth in net sales and strong sales performance of OCALIVA.
The company's focus on F3-like NASH patients and competitive positioning of OCA are key strengths.
Challenges include pricing strategy discussions and questions on combination approaches.
Opportunities lie in addressing AdCom discussions, expanding prescriber base, and preventing cirrhosis progression.

Intercept Pharma reports strong Q2 earnings, eyes FDA relations

Intercept Pharma's strong performance in Q2 2023 shows progress towards profitability by 2024. The company is addressing challenges in FDA relations and study enrollments while leveraging market opportunities for growth.

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Intercept Pharmaceuticals Inc's (NASDAQ: ICPT) pre-submission meeting to discuss the marketing application for obeticholic acid (OCA) in NASH has been moved to July (vs. June scheduling).

Regulatory Update On Intercept Pharma's Obeticholic Acid For NASH Delayed Again

Shares of Intercept Pharmaceuticals Inc. ICPT, -9.77% were up 2.2% in premarket trading on Monday after the company said a meeting with the Food and Drug Administration to discuss resubmitting an application for its experimental nonalcoholic steatohepatitis drug was moved to July from June.

Intercept set to meet with FDA in July about NASH drug

MORRISTOWN, N.J., June 06, 2022 (GLOBE NEWSWIRE) -- Intercept Pharmaceuticals, Inc. (Nasdaq:ICPT), a biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat non-viral liver diseases, today announced an update on the timing of its pre-submission meeting with the U.S. Food and Drug Administration (FDA) regarding the potential resubmission of its nonalcoholic steatohepatitis (NASH) New Drug Application (NDA) based on an interim analysis of the REGENERATE trial in patients with fibrosis due to NASH. The pre-submission meeting, previously scheduled in June, has been moved to July following a recent request from the FDA that topline data from REGENERATE be provided to the agency for its review prior to the meeting.

Intercept Provides Update on NASH Regulatory Timeline

COBALT study in advanced PBC, previously terminated early due to feasibility challenges, did not demonstrate a statistically significant difference in clinical endpoints between Ocaliva ® and placebo

Intercept Announces New Clinical Trial and Real-World Outcomes Data for Ocaliva in PBC

Final data from the phase 3 REGENERATE study, using Ocaliva for the treatment of patients with NASH fibrosis, is expected any day now. If all goes well with clinical data, Intercept expects a pre-submission meeting with the FDA in June of 2022.

Intercept: Increase Of Ocaliva Sales And A Few Catalysts

Intercept (ICPT) posts a narrower-than-expected loss in the first quarter. Sales lag estimates.

Intercept (ICPT) Q1 Earnings Top, Ocaliva Sales Miss Estimates

Intercept Pharmaceuticals, Inc. (NASDAQ:ICPT ) Q1 2022 Earnings Conference Call May 6, 2022 8:30 AM ET Company Participants Nareg Sagherian - ED, IR Jerome Durso - President and CEO Andrew Saik - CFO Linda Richardson - Chief Commercial Officer Michelle Berrey - President of Research & Development and Chief Medical Officer Conference Call Participants Yasmeen Rahimi - Piper Sandler Ritu Baral - Cowen Thomas Smith - SVB Mayank Mamtani - B. Riley Jonathan Wolliben - JMP Securities Brian Abrahams - RBC Capital Markets Michael Yee - Jefferies Jay Olson - Oppenheimer Brian Skorney - Baird Steve Seedhouse - Raymond James Joseph Stringer - Needham & Company Ellie Merle - UBS Operator Good morning, and welcome to Intercept Pharmaceuticals Q1 2022 Earnings Conference Call.

Intercept Pharmaceuticals, Inc. (ICPT) CEO Jerry Durso on Q1 2022 Results - Earnings Call Transcript

Intercept Pharmaceuticals Inc. (NASDAQ: ICPT) shares are up 30% after announcing an agreement to sell some of its foreign subsidiaries plus rights to its international operation, including the Ocaliva commercialization license outside the US, to Advanz Pharma. Advanz is a pharmaceutical firm with a strategic focus on hospital and specialty pharmaceuticals in the EU.

Here is why Intercept is up 30%

Worldwide Ocaliva® net sales of $88.6 million, representing 8% growth over the prior year quarter

Intercept Pharmaceuticals Reports First Quarter 2022 Financial Results and Provides Business Update

Intercept Pharmaceuticals Inc (NASDAQ: ICPT) has agreed to sell certain foreign subsidiaries and rights regarding its international operations, including a license to commercialize Ocaliva (obeticholic acid) outside of the U.S., to Advanz Pharma.  Intercept will receive $405.

Why Intercept Shares Are Rising Today

Intercept sold the international rights to its liver-disease treatment, Ocaliva, for up to $450 million on Thursday, and ICPT stock soared. The post Intercept Pharma Scores $450 Million Deal For Its Flagship Liver Drug appeared first on Investor's Business Daily.

Intercept Pharma Scores $450 Million Deal For Its Flagship Liver Drug

Agreement includes rights for Advanz to commercialize orphan drug Ocaliva® for PBC outside the U.S., as well as the transition to Advanz of the international commercial and medical infrastructure of Intercept

Intercept Announces Advanz Pharma to Acquire Ocaliva in PBC in Markets Outside the U.S. for up to $450MM, including $405MM Upfront and an Additional $45MM in Contingent Payments

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Intercept (ICPT) lead drug Ocaliva holds ground amid challenges. A positive readout from the NASH studies will be a good boost for the stock in the year ahead.

Intercept (ICPT) Outperforms Industry in 3 Months: What Lies Ahead?

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Intercept (ICPT) reported earnings 30 days ago. What's next for the stock?

Intercept (ICPT) Up 15.4% Since Last Earnings Report: Can It Continue?

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Intercept expects pre-submission meeting with FDA in the 1st half of 2022 as long as new REGENERATE NASH data warrants potential accelerated FDA approval.

Intercept: Opportunity To Buy On Potential NDA Resubmission Of Ocaliva For NASH

Intercept (ICPT) posts a narrower loss in the fourth quarter and sales beat estimates.

Intercept (ICPT) Q4 Earnings & Sales Beat, Ocaliva in Focus

Intercept Pharmaceuticals, Inc. (ICPT) CEO Jerry Durso on Q4 2021 Results - Earnings Call Transcript

Worldwide Ocaliva® net sales of $92.4 million and $363.5 million for the fourth quarter and full year 2021, representing 11% and 16% growth over the prior year

Intercept Pharmaceuticals Reports Fourth Quarter and Full Year 2021 Financial Results, Issues 2022 Financial Guidance and Provides Business Update

NEW YORK, Feb. 23, 2022 (GLOBE NEWSWIRE) -- Intercept Pharmaceuticals, Inc. (Nasdaq:ICPT), a biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat progressive non-viral liver diseases, will announce its fourth quarter and full year 2021 financial results prior to market open on Wednesday, March 2, 2022. The announcement will be followed by a conference call and audio webcast hosted by Intercept management at 8:30 a.m. ET to discuss the results.

Intercept to Announce Fourth Quarter and Full Year 2021 Financial Results on March 2, 2022

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B. Riley upgraded Intercept Pharmaceuticals Inc (NASDAQ: ICPT) to Buy from Neutral with a price target of $30, up from $25.  Analyst Mayank Mamtani sees a "catalyst rich" 1H of 2022 for the Company.

News for Intercept Pharma Stock (ICPT)