MTCR - Metacrine's MET642 Fast Track'd in U.S. for NASH shares up 11%

The FDA has granted Fast Track designation to Metacrine's(MTCR) MET642, the second farnesoid X receptor agonist, for the treatment of non-alcoholic steatohepatitis ((NASH)).Fast Track status provides for more frequent interaction with the FDA review team and a rolling review of the marketing application. Metacrine recently completed a Phase 1 clinical trial of MET642 in healthy volunteers, in which MET642 was safe and generally well-tolerated and demonstrated a sustained pharmacokinetic profile.The company plans to further evaluate MET642 in a Phase 2a, 16-week, trial, which is expected to begin in H1 2021.Shares up 11% premarket.

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Metacrine's MET642 Fast Track'd in U.S. for NASH, shares up 11%