Biotech Analysis Central Pharma News: Gemphire Pulls Plug, Ampio's FDA Despair, Paratek's Positive FDA Panel [Seeking Alpha]
GEMPHIRE THERAPEUTICS INC COMMON (GEMP)
Last gemphire therapeutics inc common earnings: 5/9 04:02 pm
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Source: Seeking Alpha
Summary Welcome to Biotech Analysis Central Daily News, a daily news report and analysis about what has happened lately in the biotech industry. Gemphire Stops Study For treating Pediatric Patients With NASH News: This past Friday, shares of Gemphire Therapeutics ( GEMP ) fell by as much as 75% pre-market after it had announced that its pediatric NASH study had to be stopped due to unexpected issues . The problem with the phase 2a pediatric NASH study is that 3 patients that were treated with 300 mg of gemcabene saw their liver fat increase in the study. This was the secondary endpoint and was observed over a 12-week period with the measure of MRI-PDFF (a scan imaging of the liver). Another problem had occurred with respect to the primary endpoint which was measuring serum alanine transaminase (NASDAQ: ALT ) levels. How is that significant for NASH? ALT is an enzyme biomarker implicating liver disease presence . In other words, it is a biomarker that determines
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