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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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 is a biopharmaceutical company, that engages in discovering and developing small molecule drugs and therapeutics for the treatment of chronic fibrotic and metabolic diseases. It offers INT-747, an FXR modulating agent that treats patients with chronic autoimmune liver diseases. The company's drug development programs also focus on modulating bile acid receptors, and amelioration of metabolic and hepatic functions in chronic liver diseases.

Shares of Intercept Pharmaceuticals Inc. ICPT, -1.95% tumbled 15.2% toward an 11-month low in premarket trading Monday, after the biopharmaceutical company said a U.S. Food and Drug Administration committee voted to “defer approval” for its treatment of pre-cirrhotic fibrosis due to nonalcoholic steatohepatitis (NASH). The company said 15 of 16 FDA committee members voted to defer approve until clinical outcome data from a trial are submitted and reviewed, and 12 of 16 members voted “no” on the question of whether current efficacy and safety data suggests benefits of the treatment (OCA 25 milligram) outweigh risks in NASH patients.

Intercept Pharmaceuticals stock tumbles toward 11-month low after disappointing FDA committee vote

12 of 16 voting-eligible advisors vote “no” (with two abstentions) on question, “given the available efficacy and safety data, do the benefits of OCA 25 mg outweigh the risks in NASH patients with stage 2 or 3 fibrosis?”

Intercept Announces Outcome of FDA Advisory Committee Meeting for Obeticholic Acid as a Treatment for Pre-Cirrhotic Fibrosis due to NASH

A panel of advisers to the U.S. Food and Drug Administration on Friday recommended holding off on an accelerated approval of Intercept Pharmaceuticals Inc's oral drug for a type of fatty liver disease until more study data is available.

US FDA panel votes against accelerated approval of Intercept fatty liver drug

MORRISTOWN, N.J., May 19, 2023 (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, today announced that NASDAQ has halted trading of the company's common stock.

Intercept Pharmaceuticals Stock Trading Halted Today; FDA Advisory Committee to Review Obeticholic Acid as a Treatment for Pre-Cirrhotic Fibrosis due to NASH

Intercept (ICPT) falls 14.7% a couple of days before the scheduled GIDAC meeting to review its NASH treatment on concerns of adverse events.

Intercept (ICPT) Down Ahead of GIDAC Meeting for NASH Treatment

LOS ANGELES--(BUSINESS WIRE)---- $ICPT #ICPT--The Schall Law Firm Announces it is Investigating Claims Against Intercept Pharmaceuticals, Inc. and Encourages Investors to Contact the Firm.

INVESTIGATION REMINDER: The Schall Law Firm Announces it is Investigating Claims Against Intercept Pharmaceuticals, Inc. and Encourages Investors with Losses to Contact the Firm

Intercept's (ICPT) fixed-dose combination of obeticholic acid and bezafibrate for the potential treatment of primary biliary cholangitis gets the FDA's Orphan Drug Designation.

Intercept's (ICPT) Liver Drug Combo Gets FDA's Orphan Drug Tag

The U.S. health regulator's staff reviewers on Wednesday raised a string of concerns with Intercept Pharmaceuticals' treatment for a type of fatty liver disease, sending the drugmaker's shares plunging 22%.

FDA staff flag 'serious' safety risks for Intercept's fatty-liver disease treatment

Company on track to complete planned interim analyses from two ongoing Phase 2 studies of the OCA-bezafibrate combination in 2023

Intercept Pharmaceuticals Receives FDA Orphan Drug Designation for the Fixed-Dose Combination of OCA and Bezafibrate for the Treatment of Primary Biliary Cholangitis (PBC)

Intercept (ICPT) has been having a good run in the year so far, but investors are wary ahead of the upcoming advisory meeting by the FDA's Gastrointestinal Drugs Advisory Committee to review its NDA seeking approval of OCA in steatohepatitis (NASH).

Intercept (ICPT) Gains 26.2% YTD: What's in Store?

Intercept (ICPT) reports wider-than-expected loss in the first quarter of 2023. Revenues rise year over year.

Intercept (ICPT) Q1 Earnings Miss Estimates, Revenues Up Y/Y

Intercept Pharmaceuticals reported 2023 Q1 earnings today. The company missed Wall Street's revenue estimate for the three-month period by approximately $4.7 million.

Why Intercept Pharmaceuticals Stock Plunged Today

Intercept Pharmaceuticals, Inc. (ICPT) Q1 2023 Earnings Call Transcript.

Intercept Pharmaceuticals, Inc. (ICPT) Q1 2023 Earnings Call Transcript

Intercept Pharmaceuticals (ICPT) came out with a quarterly loss of $0.77 per share versus the Zacks Consensus Estimate of a loss of $0.57. This compares to loss of $0.58 per share a year ago.

Intercept Pharmaceuticals (ICPT) Reports Q1 Loss, Lags Revenue Estimates

Ocaliva® net sales of $68.0 million, representing 15% growth over the prior year quarter Gastrointestinal Drugs Advisory Committee (GIDAC) Meeting set for May 19, 2023, to review obeticholic acid (OCA) as a treatment for pre-cirrhotic fibrosis due to NASH; PDUFA Target Action Date set for June 22, 2023 Company updates progress of OCA-bezafibrate fixed-dose combination development program in PBC, including acceptance of new Phase 2 data at EASL Congress 2023 Company to host conference call today from 8:00 a.m. – 9:30 a.m.

Intercept Pharmaceuticals Reports First Quarter 2023 Financial Results and Provides Update on Commercial Launch Strategy for NASH

Seven abstracts in primary biliary cholangitis (PBC) and nonalcoholic steatohepatitis (NASH) accepted at EASL 2023

Intercept Announces New Data to be Presented at The European Association for the Study of the Liver (EASL) Congress 2023 and Provides Update on OCA-bezafibrate Fixed-Dose Combination (FDC) Development Program

Intercept (ICPT) doesn't possess the right combination of the two key ingredients for a likely earnings beat in its upcoming report. Get prepared with the key expectations.

Intercept Pharmaceuticals (ICPT) May Report Negative Earnings: Know the Trend Ahead of Next Week's Release

MORRISTOWN, N.J., April 13, 2023 (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 first quarter 2023 financial results on Thursday, April 27, 2023, and provide an update on the commercial launch strategy for obeticholic acid (OCA) in nonalcoholic steatohepatitis (NASH). The announcement will be followed by a conference call and webcast presentation from 8:00 a.m. to 9:30 a.m. ET.

Intercept to Announce First Quarter 2023 Financial Results and Provide Update on Commercial Launch Strategy for NASH on April 27, 2023

Intercept (ICPT) witnessed a jump in share price last session on above-average trading volume. The latest trend in earnings estimate revisions for the stock suggests that there could be more strength down the road.

Intercept (ICPT) Moves 15.0% Higher: Will This Strength Last?

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NASH, or nonalcoholic steatohepatitis, is a liver inflammatory disease that can progress to fibrosis and cirrhosis. NASH is now the second leading cause of liver transplantation, and the US patient population is forecast to increase from 16 million in 2015 to 27 million in 2030.

A Perfect Storm In Pharmacotherapy: The Opportunity To Invest In NASH

Intercept (ICPT) declines on news of a GIDAC meeting to discuss the NDA for the OCA for NASH in May.

Intercept (ICPT) Stock Down on FDA Committee Update on NDA

Intercept (ICPT) gains 28.7% in the past 3 months on NDA's acceptance for NASH treatment and Ocaliva's performance.

Heres Why Intercept (ICPT) Stock is Up 28.7% in 3 Months

Intercept Pharmaceuticals said Friday its experimental liver disease treatment will face an FDA panel in May, leading ICPT stock to tumble. The post Intercept Tumbles As Its Experimental NASH Drug Faces Yet Another Obstacle appeared first on Investor's Business Daily.

Intercept Tumbles As Its Experimental NASH Drug Faces Yet Another Obstacle

Advisory Committee Meeting scheduled for May 19, 2023

Intercept Announces FDA Advisory Committee Meeting Date for Obeticholic Acid as a Treatment for Pre-Cirrhotic Liver Fibrosis due to NASH

MORRISTOWN, N.J., March 09, 2023 (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, today announced that it will be participating in investor meetings at the Barclays Global Healthcare Conference at the Loews Miami Beach Hotel on March 14, 2023.

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