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Intercept Pharmaceuticals (NASDAQ: ICPT ) -38% on FDA rejection of obeticholic acid in NASH. More news on: Intercept Pharmaceuticals, Inc., Cleveland BioLabs, Inc., China Jo-Jo Drugstores, Inc., Stocks on the move, , Read more ...
Intercept Pharmaceuticals (NASDAQ: ICPT ) slumps 37% premarket on increased volume in reaction to its announcement that is received a Complete Response Letter (CRL) from the FDA regarding its marketing application seeking approval to use obeticholic acid (OCA) to treat liv...
NEW YORK, June 29, 2020 (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 the U.S. Food and Drug Administra...
ENDRA Life Sciences Inc. (NDRA) recently announced it is moving forward with the commercialization of its Thermo Acoustic Enhanced UltraSound (TAEUS) device in Europe. The TAEUS device is essentially a point of care ((POC)) or field diagnostic hybrid of an ultrasound and MRI that can monitor...
Introduction In March, I wrote an article about Genfit (NASDAQ: GNFT ) and the potential of its lead drug candidate Elafibranor in NASH. In my analysis, I underlined the huge upward potential but also underpinned the binary characteristic of the investment case. My recommendation was to ...
French biopharma Inventiva ( OTCPK:IVEVF ) has emerged as a new player in the pursuit of a treatment for nonalcoholic steatohepatitis (NASH). More news on: Inventiva S.A., Genfit SA, CymaBay Therapeutics, Inc., Healthcare stocks news, Read more ...
Investment Thesis Intercept Pharmaceuticals, Inc. ( ICPT ) is ahead of a potential FDA approval that could unlock a market opportunity worth billions of dollars. Despite the concerns over the side effects, the drug could become the first-ever to treat liver fibrosis in NASH. However, the s...
It would be an understatement to say that we're entering June with a high level of uncertainty. While states and localities are gradually reopening across the U.S. as the measures taken to slow the spread of COVID-19 are relaxed, it's unclear how fast the economy will recover, governmental deci...
Many businesses have seen their shares tumble in the recent market plunge. Fortunately for Acadia Pharmaceuticals (NASDAQ: ACAD) , it is one of the few biotech stocks seeing positive returns. It is up 16% year to date, outperforming both the SPDR S&P Biotech ETF and the iShar...
Over the past couple of months, investors have been taken on the wildest roller-coaster ride in the stock market's history. The coronavirus disease 2019 (COVID-19) pandemic has created uncertainty and labor market disruption on a scale that's never been seen in the modern era. As a result, the...
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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 abs...
sNDA intended to satisfy post-marketing requirements to confirm a clinical benefit in patients with PBC Precedent-setting submission includes data from post-marketing studies COBALT and Study 401 as well as real-world evidence from a claims database and patient registries FDA has assign...
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% ...