FDA lifts hold on CymaBay’s NASH drug, but the com­pa­ny may still leave the ail­ing field

Eight months af­ter a sin­gle tri­al read­out blew up their NASH pro­gram, their stock price and put de­vel­op­ment around their lead com­pound on in­def­i­nite hold, CymaBay has been cleared to get back to work.

The FDA has lift­ed the clin­i­cal hold it placed on the com­pa­ny and their ex­per­i­men­tal se­ladel­par last year af­ter planned biop­sies for their NASH tri­al re­vealed “atyp­i­cal his­to­log­i­cal find­ings” — a phrase that here means the drug, rather than re­duc­ing pa­tients’ liv­er fat, ap­peared to lead to liv­er dam­age. The Phase IIb tri­al was ter­mi­nat­ed, along with a Phase IIa for pri­ma­ry scle­ros­ing cholan­gi­tis (PSC). Stud­ies on pri­ma­ry bil­iary cholan­gi­tis were put on hold. SVB Leerink called it “a worst case sce­nario” and the stock fell from $5.55 to $1.89.

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