- Intercept Pharmaceuticals (NASDAQ:ICPT) slumps 14% premarket on increased volume, poised to continue the slide that accelerated yesterday with shares down 3%. The culprit appears to be a September 8 announcement from the company that severe adverse events, including liver failure and death, can occur if physicians fail to follow the recommended dosing regimen for OCALIVA (obeticholic acid) in patients with primary biliary cholangitis (PBC).
- The note, from Chief Medical Officer David Shapiro, M.D., reviewed the FDA-approved dosing scheme and recommended patient monitoring approach, adding that healthcare providers should "exercise a low threshold for drug discontinuation or interruption based on [ ] evidence of toxicities."
- In July, the company reported a death in its mid-stage NASH study of obeticholic acid.
- NASH competitor Genfit (OTCPK:GNFTF) is up 4% in European trading.
- Previously: Intercept's Q2 beat can't overcome pressure from reported death in mid-stage NASH study; shares down 8% (July 31)
- Now read: Neurocrine Biosciences: Ingrezza's Strong Launch, Pipeline To Create Value
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Intercept under pressure on Ocaliva-associated liver injury when dosed more frequently that recommended; shares down 14% premarket
Published 09/12/2017, 08:50 AM
Intercept under pressure on Ocaliva-associated liver injury when dosed more frequently that recommended; shares down 14% premarket
Intercept under pressure on Ocaliva-associated liver injury when dosed more frequently that recommended; shares down 14% premarket
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