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With several licenses acquired from well-known pharmaceutical companies, Mirum Pharmaceuticals ( MIRM ) is a name to be followed carefully after the IPO. The most appealing is its pipeline. The company owns two product candidates at Phase 3 of development and several candidates at Phase 2 of d...
Market Assessment Clinical development of effective therapeutics for cholestatic liver diseases remained dormant for decades until recent approval of obeticholic acid (OCA) by Intercept Pharmaceuticals ( ICPT ) in 2016 for PBC. Despite clinical meaningful benefits derived from OCA, its pru...
Perspective On The Opioid Crisis Opioids are therapeutically effective at controlling pain. Unfortunately, they can equally trigger addictive behaviors when clinically misused. In the news, several mid-large cap biopharmas, privately held and publicly listed, are currently involved in "opi...
Market Assessment Eli Lilly ( LLY ) is a large-cap ($102.6B) biopharma known for innovative and diverse therapeutics for diseases affecting the endocrine system, immune system, and the brain. Its oncology products are broad with therapeutics for cancers affecting non-small cell lung, colon...
Market Assessment GlaxoSmithKline plc (GSK) is a large cap ($99B) commercial stage biopharma known for its innovative therapeutics for diverse disease states affecting many organ systems. GSK is not really a household name in reference to therapeutics for viral and non-viral liver diseases...
Market Assessment Intercept ( ICPT ), a commercial-stage liver therapeutics biopharma, gained global recognition with the development and “conditional” approval of Obeticholic acid (OCA.; ocaliva) in 2016 for the orphan chronic liver disease, PBC. A milestone achievement as t...
Medivir AB ( OTC:MVRBF ) initiated with Buy rating at H.C. Wainwright. More news on: Medivir AB (publ), Cassava Sciences, Inc., CymaBay Therapeutics, Inc., Healthcare stocks news, Stocks on the move, , Read more ...
Market Assessment Gilead (GILD) is a large cap ($88B) biopharmaceutical known for its pioneering innovative therapeutics for viral liver diseases. Gilead started 2019 with the clinical failures of selonsertib in Phase 3 NASH. As one of the Phase 3 clinical favorites for NASH, the two recen...
You only have to do very few things right in your life so long as you don't do too many things wrong. - Warren Buffett In Benjamin Graham's book The Intelligent Investor, the Father of Value Investing epitomizes the fickle nature of the equity niche as "Mr. Market." Driven by emotion, Mr. ...
It may soon be time to short diabetes and NASH-focused stocks. Maybe not just yet, but turn on a Google Alert for "Revita", "duodenal mucosal resurfacing" and "Fractyl Laboratories" and track developments over the next few months. Here's why. The solution to type II diabetes and non-alcoholic ...
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Intercept Pharmaceuticals Inc. Company Name:
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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% ...