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 (ICPT) possesses 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) Expected to Beat Earnings Estimates: Can the Stock Move Higher?

LOS ANGELES, CA / ACCESSWIRE / July 17, 2023 / The Schall Law Firm, a national shareholder rights litigation firm, announces that it is investigating claims on behalf of investors of Intercept Pharmaceuticals, Inc. ("Intercept" or "the Company") (NASDAQ:ICPT) for violations of the securities laws. The investigation focuses on whether the Company issued false and/or misleading statements and/or failed to disclose information pertinent to investors.

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

Intercept (ICPT) looks to restructure operations, discontinue all NASH-related investments and reduce its workforce by one-third.

Intercept (ICPT) to Restructure Operations, Cut Workforce

Intercept's (ICPT) NDA for obeticholic acid (OCA) gets a complete response letter (CRL) from the FDA for treating pre-cirrhotic fibrosis due to nonalcoholic steatohepatitis (NASH).

Intercept (ICPT) NDA for NASH Treatment Gets CRL From FDA

Intercept Pharmaceuticals said Friday it will restructure itself after the FDA rejected its liver disease treatment. ICPT stock sank.

Former Wall Street Darling Intercept Restructures After FDA Rejects Its Liver Drug

Intercept Pharmaceuticals Inc. ICPT, -1.62% on Friday said it will reduce its work force by one third as part of its plan to reach profitability in 2024. The layoffs will affect about 110 employees, based on the 341 total employees as of Dec. 31 that the Morristown, N.J.

Intercept to reduce work force by one third as it aims for profitability

MORRISTOWN, N.J., June 23, 2023 (GLOBE NEWSWIRE) -- Intercept Pharmaceuticals, Inc. (Nasdaq: ICPT) today announced a restructuring to strengthen the Company's focus on rare and serious liver diseases and significantly reduce operating expenses, including discontinuing all nonalcoholic steatohepatitis (NASH)-related investment.

Intercept Announces Restructuring to Strengthen Focus on Rare and Serious Liver Diseases and Significantly Reduce Operating Expenses

Planned interim analysis from the first of two Phase 2 studies shows combination of OCA 5-10 mg + bezafibrate 400 mg normalized a range of biomarkers of PBC (ALP, total bilirubin, GGT, ALT and AST) in 58% of patients at 12 weeks

Intercept Presents New Data Showing Significant Impact of OCA-bezafibrate Combination on Normalization of Multiple Biomarkers of PBC-Induced Liver Damage

The U.S. Food and Drug Administration on Thursday declined to grant accelerated approval for Intercept Pharmaceuticals' drug to treat a type of fatty liver disease.

US FDA declines to approve Intercept's fatty liver disease drug

MORRISTOWN, N.J., June 22, 2023 (GLOBE NEWSWIRE) -- Intercept Pharmaceuticals, Inc. (Nasdaq: ICPT), a biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat rare and serious liver diseases, today announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) in response to the Company's New Drug Application (NDA) for obeticholic acid (OCA) for the treatment of pre-cirrhotic fibrosis due to nonalcoholic steatohepatitis (NASH).

Intercept Receives Complete Response Letter from FDA for Obeticholic Acid as a Treatment for Pre-Cirrhotic Fibrosis due to NASH

LOS ANGELES, CA / ACCESSIWRE / June 22, 2023 / The Schall Law Firm, a national shareholder rights litigation firm, announces that it is investigating claims on behalf of investors of Intercept Pharmaceuticals, Inc. ("Intercept" or "the Company") (NASDAQ:ICPT) for violations of the securities laws. The investigation focuses on whether the Company issued false and/or misleading statements and/or failed to disclose information pertinent to investors.

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

LOS ANGELES, CA / ACCESSWIRE / June 20, 2023 / The Schall Law Firm, a national shareholder rights litigation firm, announces that it is investigating claims on behalf of investors of Intercept Pharmaceuticals, Inc. ("Intercept" or "the Company") (NASDAQ:ICPT) for violations of the securities laws. The investigation focuses on whether the Company issued false and/or misleading statements and/or failed to disclose information pertinent to investors.

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

NEW YORK , June 15, 2023 /PRNewswire/ -- Pomerantz LLP is investigating claims on behalf of investors of Intercept Pharmaceuticals, Inc. ("Intercept" or the "Company") (NASDAQ: ICPT). Such investors are advised to contact Robert S.

SHAREHOLDER ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Intercept Pharmaceuticals, Inc. - ICPT

Intercept Pharmaceuticals (ICPT) announces new data showing the potential of a fixed-dose combination of OCA and bezafibrate to normalize multiple biomarkers in primary biliary cholangitis.

Intercept (ICPT) Announces Positive Data From PBC Study

LOS ANGELES, CA / ACCESSWIRE / May 31, 2023 / The Schall Law Firm, a national shareholder rights litigation firm, announces that it is investigating claims on behalf of investors of Intercept Pharmaceuticals, Inc. ("Intercept" or "the Company") (NASDAQ:ICPT) for violations of the securities laws. The investigation focuses on whether the Company issued false and/or misleading statements and/or failed to disclose information pertinent to investors.

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

LOS ANGELES, CA / ACCESSWIRE / May 27, 2023 / The Schall Law Firm, a national shareholder rights litigation firm, announces that it is investigating claims on behalf of investors of Intercept Pharmaceuticals, Inc. ("Intercept" or "the Company") (NASDAQ: ICPT) for violations of the securities laws. The investigation focuses on whether the Company issued false and/or misleading statements and/or failed to disclose information pertinent to investors.

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

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LOS ANGELES, CA / ACCESSWIRE / May 22, 2023 / The Schall Law Firm, a national shareholder rights litigation firm, announces that it is investigating claims on behalf of investors of Intercept Pharmaceuticals, Inc. ("Intercept" or "the Company") (NASDAQ:ICPT) for violations of the securities laws. The investigation focuses on whether the Company issued false and/or misleading statements and/or failed to disclose information pertinent to investors.

SHAREHOLDER ACTION ALERT: 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) NASH treatment does not succeed in getting GIDAC's recommendation for an approval. The committee recommends deferring approval until clinical data from another study is available.

Intercept (ICPT) NASH Treatment Fails to Get GIDAC Recommendation

Intercept Pharmaceuticals Inc  (NASDAQ: ICPT) stock is down 19.3% at $10.95, after a Food and Drug Administration (FDA) panel voted against recommending accelerated approval for its obeticholic acid treatment for non-alcoholic steatohepatitis (NASH) -- a type of fatty liver disease.

Biotech Hits Record Low on FDA Curveball

The FDA will likely reject Intercept Pharmaceuticals' highly watched liver disease treatment, analysts said Monday as ICPT stock crashed. The post Intercept Crashes As FDA Advisors Deliver The Likely Deathblow For Its Highly Watched NASH Drug appeared first on Investor's Business Daily.

Intercept Crashes As FDA Advisors Deliver The Likely Deathblow For Its Highly Watched NASH Drug

Shares of Intercept Pharmaceuticals Inc fell 16% on Monday over concerns about the prospects of the company's drug to treat a type of fatty liver disease after the regulator's advisory panel voted to defer an accelerated approval.

Intercept shares tumble on concerns over NASH drug prospects

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.

News for Intercept Pharma Stock (ICPT)