Intercept Pharmaceuticals, Inc. (ICPT)

Intercept Pharmaceuticals said on Thursday it is voluntarily withdrawing its liver disease treatment from the U.S. market following a request from the Food and Drug Administration.

Intercept Pharmaceuticals' liver disease drug can cause injury to the organ in patients without severe scarring, the U.S. Food and Drug Administration said on Thursday, based on its review of postmarket clinical trial data.

The U.S. Food and Drug Administration on Tuesday declined full approval for Intercept Pharmaceuticals' liver disease drug, raising questions about its future in the market.

MORRISTOWN, N.J., Nov. 12, 2024 (GLOBE NEWSWIRE) -- Intercept Pharmaceuticals, Inc., a wholly owned biopharmaceutical subsidiary of Alfasigma S.p.A., today announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) that addresses the supplemental New Drug Application (sNDA) for OCALIVA® (obeticholic acid, OCA) seeking full approval for the treatment of indicated patients with primary biliary cholangitis (PBC) – a rare, progressive disease that disproportionally affects women.

Independent advisers to the U.S. Food and Drug Administration voted on Friday against confirmatory trial data for Intercept Pharmaceuticals' liver disease drug, putting into question the treatment's future in the U.S. market.

The U.S. Food and Drug Administration's staff on Wednesday raised concerns over the efficacy of Intercept Pharmaceuticals' liver disease drug, which is awaiting the regulator's traditional approval.

Loomis AB (publ) (OTCMKTS:LOIMF – Get Free Report) and Sophos Group (OTCMKTS:SPHHF – Get Free Report) are both business services companies, but which is the better stock? We will compare the two businesses based on the strength of their profitability, earnings, analyst recommendations, dividends, risk, institutional ownership and valuation. Analyst Recommendations This is a breakdown of current recommendations and price targets for Loomis AB (publ) and Sophos Group, as provided by MarketBeat.com. Sell Ratings Hold Ratings Buy Ratings Strong Buy Ratings Rating Score Loomis AB (publ) 0 0 0 0 N/A Sophos Group 0 0 0 0 N/A Volatility & Risk Loomis AB (publ) has a beta of 1.25, meaning that its stock price is 25% more volatile than the S&P 500. Comparatively, Sophos Group has a beta of 0.53, meaning that its stock price is 47% less volatile than the S&P 500. Valuation and Earnings This table compares Loomis AB (publ) and Sophos Group’s top-line revenue, earnings per share (EPS) and valuation. Gross Revenue Price/Sales Ratio Net Income Earnings Per Share Price/Earnings Ratio Loomis AB (publ) $2.71 billion 0.64 $140.94 million $1.93 12.56 Sophos Group $710.60 million 4.61 $26.90 million $0.14 50.00 Loomis AB (publ) has higher revenue and earnings than Sophos Group. Loomis AB (publ) is trading at a lower price-to-earnings ratio than Sophos Group, indicating that it is currently the more affordable of the two stocks. Profitability This table compares Loomis AB (publ) and Sophos Group’s net margins, return on equity and return on assets. Net Margins Return on Equity Return on Assets Loomis AB (publ) 4.98% 10.99% 3.92% Sophos Group N/A N/A N/A Summary Loomis AB (publ) beats Sophos Group on 7 of the 9 factors compared between the two stocks. About Loomis AB (publ) (Get Free Report) Loomis AB (publ) provides solutions for the distribution, payments, handling, storage, and recycling of cash and other valuables. The company offers a range of solutions for cash in transit, cash management services, foreign exchange services, automated teller machines, automated solutions, and international valuables logistics, as well as operates Loomis Pay, a payment service that enables processing of various types of payment methods, such as card, cash, and digital alternatives. It serves financial institutions, banks, retailers, commercial enterprises, and other customers, as well as public sector in Sweden, the United States, France, Switzerland, Spain, the United Kingdom, and internationally. Loomis AB (publ) was founded in 1852 and is headquartered in Stockholm, Sweden. About Sophos Group (Get Free Report) Sophos Group plc, through its subsidiaries, provides cloud-enabled end-user and network security solutions. The company offers XG Firewall, a next-generation firewall protection for network, users, and applications from new control center; SG UTM, a user interface to protect network and users; Secure Wi-Fi, a wireless access point; Secure Web Gateway for Web security; Secure Email Gateway solutions; and Phish Threat, an email phishing test simulation and training product. It also provides Endpoint Protection, a security solution for users and data; Intercept X, an endpoint security solution; Sophos Mobile, an enterprise mobility management solution; SafeGuard Encryption solution; Server Protection solution; Sophos Home, a protection solution for home computers; and Sophos Central, a synchronized security management solution. In addition, the company offers OEM solutions; professional services; SophosLabs, a threat research and intelligence center; and Public Cloud, a cloud computing solution to provide and deploy IT infrastructure, such as networks, compute capacity, storage, and databases. It serves education, healthcare, retail, finance, and banking industries, as well as governments and public sectors in the Americas, Europe, the Middle East, Africa, the Asia Pacific, and Japan. Sophos Group plc was founded in 1985 and is headquartered in Abingdon, the United Kingdom.

Gilead Sciences, Inc. (GILD Quick QuoteGILD - Free Report) announced positive interim results from the ongoing ASSURE study on pipeline candidate seladelpar.ASSURE is an open-label study evaluating the long-term safety and efficacy of seladelpar, a once-daily potent and selective peroxisome proliferator-activated receptor (PPAR) delta agonist or delpar.Seladelpar is a first-in-class oral, selective PPAR-delta agonist or delpar is being evaluated for treating primary biliary cholangitis (PBC).The study enrolled adult patients with PBC who previously participated in a study of seladelpar where a key eligibility criterion included an inadequate response or intolerance to ursodeoxycholic acid (UDCA). Most patients enrolled in ASSURE were female (94%), with a mean age of 59 years.PBC is a rare, chronic, cholestatic liver disease mainly affecting women.We remind investors that the candidate was added to Gilead’s pipeline following the recent acquisition of CymaBay Therapeutics, Inc. The interim results showed that treatment with seladelpar led to improvements in markers of cholestasis and reduced inflammation. Additional findings demonstrate that seladelpar can help reduce pruritus (itch) in people living with PBC.This analysis did not include patients from the late-stage RESPONSE study, which will be reported separately.The study also evaluated several prespecified biochemical endpoints, including the composite response of alkaline phosphatase (ALP) below 1.67 x upper limit of normal (ULN), a decline in ALP of at least 15% and total bilirubin (TB) below the ULN.70% of patients receiving seladelpar 10mg achieved the clinically meaningful composite endpoint and 37% achieved ALP normalization at 12 months.The reduction in patient-reported pruritus was rapid and durable in patients with moderate to severe symptoms.Please note that a new drug application (NDA) for seladelpar for the treatment of PBC, including pruritus, in adults without cirrhosis or with compensated cirrhosis (Child Pugh A) who are inadequate responders or intolerant to UDCA is under review in the United States.The FDA granted priority review to the NDA and set a target action date of Aug 14, 2024. The candidate is also under review in Europe.Seladelpar received FDA Breakthrough Therapy Designation for the treatment of PBC, including pruritus in patients without cirrhosis or with compensated cirrhosis and PRIME status (EMA) and Orphan Drug Designation in the United States and Europe for treating patients with PBC.Gilead’s shares have lost 16.4% year to date compared with the industry's decline of 5%. Image Source: Zacks Investment ResearchLast month, GILD reported better-than-expected results for the first quarter of 2024 as its loss was narrower than expected and sales beat estimates.Gilead Sciences, Inc. Price, Consensus and EPS Surprise Gilead Sciences, Inc. price-consensus-eps-surprise-chart | Gilead Sciences, Inc. Quote The company intends to expand its portfolio beyond the HIV franchise. The acquisition of CymaBay complements Gilead’s existing liver portfolio and a potential approval of seladelpar for PBC will strengthen this franchise.Intercept Pharmaceuticals’ Ocaliva (obeticholic acid) received accelerated approval from the FDA in 2016 for the treatment of adult patients living with PBC without cirrhosis or with compensated cirrhosis who do not have evidence of portal hypertension, either in combination with UDCA with an inadequate response to UDCA or as monotherapy in patients unable to tolerate UDCA.Zacks Rank & Stocks to ConsiderGilead currently carries a Zacks Rank #5 (Strong Sell).A couple of better-ranked stocks from the healthcare industry are Ligand Pharmaceuticals (LGND Quick QuoteLGND - Free Report) and ANI Pharmaceuticals (ANIP Quick QuoteANIP - Free Report) . Both stocks carry a Zacks Rank #2 (Buy). In the past 30 days, the Zacks Consensus Estimate for Ligand’s 2024 and 2025 earnings per share (EPS) has remained constant at $4.56 and $5.27, respectively. Shares of LGND are up 20.5% year to date.In the past 60 days, estimates for ANI Pharmaceuticals’ 2024 EPS have improved from $4.43 to $4.44. Shares of ANIP have jumped 11.4% year to date. ANIP’s earnings beat estimates in each of the trailing four quarters, delivering an earnings surprise of 53.90%, on average. Zacks Names "Single Best Pick to Double" From thousands of stocks, 5 Zacks experts each have chosen their favorite to skyrocket +100% or more in months to come. From those 5, Director of Research Sheraz Mian hand-picks one to have the most explosive upside of all. It’s a little-known chemical company that’s up 65% over last year, yet still dirt cheap. With unrelenting demand, soaring 2022 earnings estimates, and $1.5 billion for repurchasing shares, retail investors could jump in at any time. This company could rival or surpass other recent Zacks’ Stocks Set to Double like Boston Beer Company which shot up +143.0% in little more than 9 months and NVIDIA which boomed +175.9% in one year.Free: See Our Top Stock and 4 Runners Up >>

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 supplemental New Drug Application (sNDA) for Ocaliva for the treatment of individuals with primary biliary cholangitis (PBC). The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of October 15, 2024. In this communication, the agency informed Intercept that they are planning to hold an Advisory Committee meeting to discuss the application.

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.

BOLOGNA, Italy & MORRISTOWN, N.J.--(BUSINESS WIRE)--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 applicab.

BOLOGNA, Italy--(BUSINESS WIRE)--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 schedule.

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NEW ORLEANS--(BUSINESS WIRE)--Former Attorney General of Louisiana Charles C. Foti, Jr., Esq. and the law firm of Kahn Swick & Foti, LLC (“KSF”) are investigating the proposed sale of Intercept Pharmaceuticals, Inc. (NasdaqGS: ICPT) to Alfasigma S.p.A. Under the terms of the proposed transaction, shareholders of Intercept will receive $19.00 in cash for each share of Intercept that they own. KSF is seeking to determine whether this consideration and the process that led to it are adequate,.

NEW ORLEANS--(BUSINESS WIRE)--Former Attorney General of Louisiana Charles C. Foti, Jr., Esq. and the law firm of Kahn Swick & Foti, LLC (“KSF”) are investigating the proposed sale of Intercept Pharmaceuticals, Inc. (NasdaqGS: ICPT) to Alfasigma S.p.A. Under the terms of the proposed transaction, shareholders of Intercept will receive $19.00 in cash for each share of Intercept that they own. KSF is seeking to determine whether this consideration and the process that led to it are adequate,.