MORRISTOWN, N.J., May 09, 2024 (GLOBE NEWSWIRE) -- Intercept Pharmaceuticals, Inc., a biopharmaceutical company and wholly owned subsidiary of Alfasigma S.p.A. focused on the development and commercialization of novel therapeutics to treat rare and serious liver diseases, today announced five abstracts on primary biliary cholangitis (PBC) will be presented at Digestive Disease Week® (DDW) 2024. The conference will be held from May 18-21 in Washington, D.C. "We are pleased to participate in this year's DDW and share our latest findings, including new data from our Phase 2 trial evaluating a fixed-dose combination of obeticholic acid and bezafibrate in patients with PBC," said Sangeeta Sawh

sNDA intended to satisfy post-marketing requirements to confirm a clinical benefit in patients with PBCPrecedent-setting submission includes data from post-marketing studies COBALT and Study 401 as well as real-world evidence from a claims database and patient registriesFDA has assigned a PDUFA target action date of October 15, 2024 MORRISTOWN, N.J., Feb. 29, 2024 (GLOBE NEWSWIRE) -- Intercept Pharmaceuticals, Inc., a biopharmaceutical company and wholly owned subsidiary of Alfasigma S.p.A. 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 accepted its supple

BOLOGNA, Italy and MORRISTOWN, N.J., Nov. 08, 2023 (GLOBE NEWSWIRE) -- Alfasigma S.p.A. ("Alfasigma") and Intercept Pharmaceuticals, Inc. ("Intercept") announced today the completion of the acquisition of Intercept by Alfasigma through its wholly owned subsidiary Interstellar Acquisition Inc. Following the completion of Alfasigma's successful tender offer to purchase all outstanding shares of common stock of Intercept for USD 19.00 per share, net to the seller thereof in cash, without interest, less any applicable withholding of taxes, Alfasigma acquired all remaining shares of common stock of Intercept through a merger pursuant to Section 251(h) of the General Corporation Law of the St

Alfasigma S.p.A. ("Alfasigma") announced today that it has, through its wholly owned subsidiary Interstellar Acquisition Inc. ("Interstellar"), successfully completed its tender offer to purchase all outstanding shares of common stock of Intercept Pharmaceuticals, Inc. (NASDAQ:ICPT) ("Intercept"), at a price of USD 19.00 per share, net to the seller thereof in cash, without interest, less any applicable withholding of taxes. The tender offer expired as scheduled at one minute after 11:59 p.m., Eastern Time on November 7, 2023 (12:00 midnight, Eastern Time, on November 8, 2023). As of the expiration, 31,158,412 shares of common stock of Intercept had been validly tendered and not validly w

Alfasigma S.p.A. ("Alfasigma") today announced that the required waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 (the "HSR Act") with respect to Alfasigma's proposed acquisition of Intercept Pharmaceuticals, Inc. (NASDAQ:ICPT) ("Intercept") expired at 11:59 p.m. on October 25, 2023. The expiration of the HSR Act waiting period satisfies one of the conditions to consummate the tender offer. Other customary offer conditions remain to be satisfied, including, among others, a minimum tender of at least a majority of outstanding Intercept common stock. Unless the tender offer is extended or earlier terminated in accordance with the rules and regulations of the SEC a

-Mr. Bradbury has over 35 years of experience leading fast-growing life sciences companies- Persephone Biosciences Inc., a biotechnology company reimagining patient health through the development of microbiome-based medicines, today announced that it has appointed Daniel Bradbury as Chair of the Board of Directors. "We are delighted to welcome Dan to our Board. His appointment reflects the recent progress we have made with our MyBabyBiome™ study of infant gut health, and our near-term plans to commercialize our first product based on the findings. Additionally, Persephone has a further two clinical studies underway, namely our ARGONAUT study of gut microbiome-linked immune modulation in

Alfasigma S.p.A. ("Alfasigma") today announced that its wholly-owned subsidiary, Interstellar Acquisition Inc., a Delaware corporation ("Purchaser"), has commenced a cash tender offer to purchase all of the outstanding shares of common stock, par value USD $0.001 per share, of Intercept Pharmaceuticals, Inc. (NASDAQ:ICPT) ("Intercept") for a price of USD $19.00 per share, net to the holder thereof in cash, without interest, less any applicable withholding of taxes (the "Offer"). The Offer is being made upon the terms and subject to the conditions set forth in the Offer to Purchase, dated October 11, 2023, and the related Letter of Transmittal and pursuant to the terms of the previously anno

NEW YORK, Sept. 30, 2023 (GLOBE NEWSWIRE) -- Renovaro Biosciences, Inc. (NASDAQ:RENB) Lifshitz Law PLLC announces an investigation into possible breach of fiduciary duties in connection with the merger of RENB and GEDi Cube Intl Ltd. Under the terms of the proposed transaction, GEDi Cube Intl Ltd. equity interests will be exchanged for shares of RENB common stock through a stock-for-stock acquisition. If you are a RENB investor, and would like additional information about our investigation, please complete the Information Request Form or contact Joshua Lifshitz, Esq. by telephone at (516)493-9780 or e-mail at [email protected]. Blue Apron Holdings, Inc. (NASDAQ:APRN) Lifshitz Law

Proposed all-cash acquisition will materially expand Alfasigma's portfolio in gastroenterology and hepatology and its presence in the U.S. marketTransaction price represents an 82% premium to Intercept's closing price on September 25, 2023Alfasigma adds Ocaliva®, the only FDA approved second-line treatment for PBC, a progressive autoimmune disease affecting the liver, which generated revenue of $152 million in 1H 2023Strengthens Alfasigma's pipeline, including the addition of a novel fixed-dose combination with potential to establish a new treatment paradigm in PBCAlfasigma to commence cash tender offer to acquire all issued and outstanding shares of Intercept for U.S. $19.00 per shareTransa

MORRISTOWN, N.J., Sept. 05, 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 Jerry Durso, President and Chief Executive Officer of Intercept, and Andrew Saik, Chief Financial Officer of Intercept, will participate in fireside chats and investor meetings at the following upcoming investor conferences:  The H.C. Wainwright 25th Annual Global Investment Conference, for which the chat will be taking place on September 11th, 2023, from 11:00-11:30am ET. The Baird Global Healthcare Conference, for which the chat

MORRISTOWN, N.J., July 26, 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, will announce its second quarter 2023 financial results on Wednesday, August 2, 2023. The announcement will be followed by a conference call and audio webcast at 8:30 a.m. ET. Participants can access the conference call live via webcast which will be available on the investor page of the company's website at http://ir.interceptpharma.com. Participants who wish to ask a question may register here to receive dial-in numbers and a unique pin to join the

Company to discontinue all NASH-related investment and restructure the Company's operations to strengthen its focus on rare and serious liver diseasesCompany anticipates achieving profitability in 2024 as a result of planned actionsConference call scheduled for Friday, June 23, 2023, at 8:30 a.m. ET 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 Applicat

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?" 15 of 16 voting-eligible advisors vote to "defer approval until clinical outcome data from trial 747-303 are submitted and reviewed, at which time the traditional approval pathway could be considered" PDUFA Target Action Date set for June 22, 2023 Company to host conference call on Monday, May 22, 2023, at 8:30 a.m. ET MORRISTOWN, N.J., May 19, 2023 (GLOBE NEWSWIRE) -- Intercept Pharmaceuticals, Inc. (NASDAQ:ICPT), a biopharmaceutical company focused on the development

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. The Company, which has filed a New Drug Application (NDA) seeking accelerated approval of OCA for the treatment of patients with pre

U.S. Ocaliva® net sales of $77.2 million and $285.7 million for the fourth quarter and full year 2022, representing 13% and 10% growth over the prior year Worldwide Ocaliva® non-GAAP adjusted net sales of $343.8 million for the full year 2022 As of December 31, 2022, Company has cash, cash equivalents, restricted cash, and investment debt securities available for sale of $490.9 million PDUFA target action date set for June 22, 2023, for OCA for the treatment of pre-cirrhotic liver fibrosis due to NASH Company has fully resolved the patent infringement litigation that was scheduled for trial on February 27, 2023; settlements protect Ocaliva market exclusivity into the 2030s Company to h

MORRISTOWN, N.J., Feb. 23, 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 fourth quarter and full-year 2022 financial results on Thursday, March 2, 2023. The announcement will be followed by a conference call and audio webcast at 8:30 a.m. ET.   Participants can access the conference call live via webcast which will be available on the investor page of the company's website at http://ir.interceptpharma.com. Participants who wish to ask a question may register here to receive dial-in numbers and a unique

U.S. Ocaliva® net sales of $77.6 million; 16.4% growth over the prior year quarter Company increases 2022 Ocaliva non-GAAP adjusted net sales guidance to $340 million to $350 million and narrows non-GAAP adjusted operating expense guidance to $350 million to $365 million  As of September 30, 2022, Company has cash, cash equivalents, restricted cash, and investment debt securities available for sale of $497.8 million Company remains on track to resubmit new drug application (NDA) for obeticholic acid (OCA) in liver fibrosis due to NASH by end of 2022 based on the positive Phase 3 REGENERATE study MORRISTOWN, N.J., Nov. 01, 2022 (GLOBE NEWSWIRE) -- Intercept Pharmaceuticals, Inc. (NASDA

MORRISTOWN, N.J., Oct. 25, 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 third quarter 2022 financial results prior to market open on Tuesday, November 1, 2022. The announcement will be followed by a conference call and audio webcast at 8:30 a.m. ET.  Participants can access the conference call live via webcast which will be available on the investor page of our website at http://ir.interceptpharma.com. Participants who wish to ask a question may register here to receive dial-in numbers and a unique pi

Worldwide Ocaliva® non-GAAP adjusted net sales in PBC of $100.4 million; U.S. net sales of $71.8 million representing 5% growth over the prior year quarter Company reissues 2022 financial guidance to reflect impact of sale of international business: Ocaliva non-GAAP adjusted net sales guidance of $325 million to $345 million and non-GAAP adjusted operating expense guidance of $335 million to $365 million Intercept completed the sale of its international business for $405 million in upfront consideration on July 1, 2022 Following pre-submission meeting with FDA, Company to resubmit new drug application (NDA) in liver

MORRISTOWN, N.J., July 27, 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 second quarter 2022 financial results prior to market open on Wednesday, August 3, 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. Participants can access the conference call live via webcast which will be available on the investor page of our website at http://ir.interceptpharma.com. Participants who wish to ask a question may re

Monday, Gilead Sciences Inc (NASDAQ:GILD) agreed to acquire  CymaBay Therapeutics Inc (NASDAQ:CBAY) for $32.50 per share in cash or a total equity value of $4.3 billion. The addition of CymaBay’s investigational lead product candidate, seladelpar for primary biliary cholangitis (PBC), including pruritus, complements Gilead’s existing liver portfolio. Baird writes that Gilead’s investment in seladelpar for liver disease appears to be a strategically sound move, especially compared to potential investments in oncology.  The company’s focus on a space where it has demonstrated commercial success is seen as a positive step to restore confidence in its growth prospects.  Despite the m

Data from two Phase 2 studies in PBC show combination of OCA + bezafibrate achieved biochemical remission (normalization of ALP, total bilirubin, GGT, ALT and AST) in 40-44% of patients in the first 12 weeks OCA 5 or 5-10 mg + bezafibrate 400 mg cohorts in both studies showed a >60% reduction from baseline in serum ALP (primary endpoint)Treatment-emergent adverse events were generally balanced across all cohorts in both studiesData support progression to Phase 3 trials of sustained release formulation of bezafibrate with low doses of OCAResults featured in late-breaking poster presentation on Monday, November 13, during The Liver Meeting® 2023MORRISTOWN, N.J., Nov. 13, 2023 (GLOBE NEWSWIRE)

New analysis demonstrates the impact of OCA on achievement of GGT <3.2×ULN and ALP <1.5×ULNFindings suggest that OCA has the potential to reduce the liver biomarker GGT, in addition to well-known effects on ALP, below thresholds that predict improved outcomes, including survival, in PBCData to be featured in poster presentation on Monday, November 13MORRISTOWN, N.J., Nov. 10, 2023 (GLOBE NEWSWIRE) -- Intercept Pharmaceuticals, Inc., a biopharmaceutical company and wholly-owned subsidiary of Alfasigma S.p.A. focused on the development and commercialization of novel therapeutics to treat rare and serious liver diseases, today announced new data from a sub-analysis of the landmark Phase 3 POISE

Alfasigma S.p.A. ("Alfasigma") today announced that the required waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 (the "HSR Act") with respect to Alfasigma's proposed acquisition of Intercept Pharmaceuticals, Inc. (NASDAQ:ICPT) ("Intercept") expired at 11:59 p.m. on October 25, 2023. The expiration of the HSR Act waiting period satisfies one of the conditions to consummate the tender offer. Other customary offer conditions remain to be satisfied, including, among others, a minimum tender of at least a majority of outstanding Intercept common stock. Unless the tender offer is extended or earlier terminated in accordance with the rules and regulations of the SEC an

The most overbought stocks in the health care sector presents an opportunity to go short on these overvalued companies. The RSI is a momentum indicator, which compares a stock's strength on days when prices go up to its strength on days when prices go down. When compared to a stock's price action, it can give traders a better sense of how a stock may perform in the short term. An asset is typically considered overbought when the RSI is above 70. Here’s the latest list of major overbought players in this sector. Structure Therapeutics Inc. (NASDAQ:GPCR) Structure Therapeutics recently released results from the Phase 1b multiple ascending dose (MAD) study of GSBR-1290 in healthy, overw

https://www.ema.europa.eu/en/documents/referral/ocaliva-article-20-procedure-review-ocaliva-started_en.pdf Review of Ocaliva started EMA's human medicines committee (CHMP) has started a review of the medicine Ocaliva (obeticholic acid), used to treat adults with primary biliary cholangitis (PBC). PBC is an autoimmune condition that causes gradual destruction of the small bile ducts in the liver, which can lead to liver failure and increase the risk of liver cancer. The review was prompted by the final results from two studies in patients with PBC, which were requested by EMA in 2016 as part of the conditions to the initial marketing authorisation of Ocaliva. Study 747-302 was designed to con

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B. Riley Securities analyst Mayank Mamtani downgrades Intercept Pharma (NASDAQ:ICPT) from Buy to Neutral and raises the price target from $15 to $19.

RBC Capital analyst Brian Abrahams maintains Intercept Pharma (NASDAQ:ICPT) with a Sector Perform and raises the price target from $12 to $19.