FDA backs Mike Grey's bet on a comeback drug play with breakthrough status for maralixibat
Rolling off a $75 million IPO, liver disease biotech Mirum Pharmaceutical has gained FDA breakthrough status for its treatment for Alagille syndrome (ALGS) in patients 1-years-old and over.
Five years ago, Mike Grey sold maralixibat for $260 million to Shire, which hoped to quickly turn the experimental compound into an approved drug for excess bile and extreme itching. But within a year the drug had failed a mid-stage trial for ALGS and within three years it had failed for another disease, primary sclerosing cholangitis. Grey reacquired the drug in 2018, believing he could do with his compound what the giant biotech couldn’t.
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