Intercept Pharmaceuticals, Inc.
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Latest From Intercept Pharmaceuticals, Inc.
Keeping Track Of Breakthroughs: AZ Farxiga, ImmunoGen ADC For Hematologic Cancer, Inventiva NASH Candidate Earn Designation
The latest breakthrough therapy designation news and highlights from the Pink Sheet’s US FDA Performance Tracker.
Recent development upheaval in non-alcoholic steatohepatitis has created opportunity for new approaches, and Poxel thinks its AMPK activator may address several NASH-related pathologies.
Akero gets FDA’s ok to conduct Phase IIb/III study of FGF21 analog efruxifermin in biopsy-confirmed non-alcoholic steatohepatitis patients. With NASH leadership up in the air, Akero, 89bio and other FGF analog sponsors jockey for top spot.
As agency observers wonder whether and how political considerations will impact the timing of a COVID-19 vaccine approval or authorization, the Pink Sheet looks at instances through the years where agency staffers found themselves operating under precedents with which they disagreed or that didn’t work out as expected.