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2023-05-24 13:17:07 ET Shares of the clinical-stage drugmaker Madrigal Pharmaceuticals (NASDAQ: MDGL) were up by 6.2% on elevated volume as of 12:16 p.m. ET Wednesday. The biotech appears to be benefiting from two key tailwinds. First, a Food and Drug Administration (FDA) panel ...
2023-05-22 13:42:11 ET Intercept Pharmaceuticals ( NASDAQ: ICPT ) fell ~28% on Monday as its shares resumed trading after a group of independent experts at the FDA declined to recommend its liver disease therapy obeticholic acid (OCA) for nonalcoholic steatohepatitis (NASH). ...
2023-05-22 13:17:02 ET Summary After last Friday’s unfavorable AdCom meeting, Intercept’s NASH candidate now appears dead on arrival. Some analysts have suggested that Intercept's valuation will be buttressed by their PBC franchise - which may be extended if their OC...
2023-05-22 12:55:14 ET Gainers: Microbot Medical ( MBOT ) +132% . Greenhill & Co ( GHL ) +117% . Hepion Pharmaceuticals ( HEPA ) +64% . Akebia Therapeutics ( AKBA ) +39% . VectivBio Holding ( VECT ) +36% . Atea Phar...
NEW YORK, May 22, 2023 (GLOBE NEWSWIRE) -- Kaplan Fox & Kilsheimer LLP ( www.kaplanfox.com ) is investigating potential claims on behalf of investors who purchased Intercept Pharmaceuticals, Inc. (Nasdaq: ICPT) securities. Click Here To Join Investigation. If you purch...
2023-05-22 08:53:42 ET Rain Oncology ( RAIN ) +-82% Announces Topline Results from Phase 3 MANTRA Trial of Milademetan for the Treatment of Dedifferentiated Liposarcoma. Volcon ( VLCN ) +-30% slides after announcing new equity offering. Mallinckrodt ( MNK...
2023-05-20 02:29:09 ET Summary On Friday, the Gastrointestinal Drugs Advisory Committee voted against the approval of OCA for treating nonalcoholic steatohepatitis (NASH). The recommendation to delay approval until additional trial data becomes available was almost universally agr...
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...
2023-05-19 07:51:30 ET Intercept Pharmaceuticals ( NASDAQ: ICPT ) said Nasdaq has halted trading of its common stock ahead of a U.S. Food and Drug Administration (FDA) panel meeting today to review its liver disease therapy Obeticholic Acid (OCA). The FDA's Gastroint...
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 th...
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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% ...