Daniel Gold, MEI Pharma CEO (via website/Vimeo)

As FDA door shuts on its PI3K, MEI Phar­ma throws in the tow­el, lays off staff

Hav­ing steered a PI3K in­hibitor from pre­clin­i­cal stud­ies all the way to Phase II, San Diego’s MEI Phar­ma is all but wash­ing its hands of the drug as the FDA rais­es the bar on the class.

The biotech is dis­con­tin­u­ing de­vel­op­ment of zan­delis­ib every­where ex­cept Japan, where its part­ner Ky­owa Kirin will move for­ward with on­go­ing tri­als and ex­plore an ap­proval based on Phase II da­ta. While MEI Phar­ma had orig­i­nal­ly hoped to do the same in the US, the FDA put its foot down and asked for a new clin­i­cal tri­al — which it de­cid­ed isn’t worth the ef­fort.

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