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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...
2024-01-02 11:12:57 ET Summary Madrigal Pharmaceuticals, Inc. stock has rallied 70% since late October due to a decrease in competitive concerns and a large secondary offering. The company's candidate resmetirom is expected to be the first approved therapy for NASH in March 2024. ...
2023-11-27 10:34:03 ET More on Tharimmune, Inc. Financial information for Tharimmune, Inc. For further details see: Tharimmune stock rockets 46% on positive Phase 1 data for PBC drug
2023-11-19 09:52:24 ET Summary Today, we revisit CymaBay Therapeutics, a clinical stage biopharma company focused on developing therapies for liver and chronic diseases. The company's primary product candidate, seladelpar, has shown positive results in treating primary biliary cho...
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% ...
New analysis demonstrates the impact of OCA on achievement of GGT <3.2×ULN and ALP <1.5×ULN Findings 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, inc...
Weyco Group Inc. (WEYS) is expected to report for Q1 2024 Gladstone Land Corporation (LAND) is expected to report $0.16 for Q3 2023 PlayAGS Inc. (AGS) is expected to report $0.01 for Q3 2023 Ardmore Shipping Corporation (ASC) is expected to report $0.43 for Q3 2023 Sage Therapeuti...
Intercept Pharmaceuticals Inc. (ICPT) is expected to report $-0.27 for Q3 2023
2023-10-13 15:47:48 ET Intercept Pharmaceuticals, which agreed to be sold to Sanofi ( NASDAQ: SNY ) late last month, quickly dropped 3% amid a new report from the European Medicines Agency. The study failed to show that Ocaliva was more effective than placebo (a dummy trea...
NEW YORK, NY / ACCESSWIRE / October 4, 2023 / Halper Sadeh LLC, an investor rights law firm, is investigating the following companies for potential violations of the federal securities laws and/or breaches of fiduciary duties to shareholders relating to: Intercept Pharmaceuticals, Inc. (NAS...
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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...
Monday, Gilead Sciences Inc (NASDAQ:GILD) agreed to acquire CymaBay Therapeutics Inc (NASDAQ:CBAY) for $32.50 per share i...
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% ...