FDA hits the red light on piv­otal tri­als at Newron, de­mand­ing new stud­ies af­ter rais­ing safe­ty con­cerns

Two years af­ter Newron $NWRN came up with a mixed set of Phase IIa da­ta for its an­tipsy­chot­ic eve­namide, the FDA is halt­ing their move in­to piv­otal work while the biotech ex­plores the im­pli­ca­tions of some new safe­ty con­cerns re­gard­ing the drug.

Those con­cerns in­volve sig­nals spot­ted in a new­ly com­plet­ed rat study — which were not ex­plained — as well as “CNS events at high­er dos­es in dogs, and the po­ten­tial im­pli­ca­tion of these find­ings for pa­tients.” Reg­u­la­tors now want to see some new an­i­mal and hu­man stud­ies done to ad­dress the safe­ty is­sue be­fore they launch Phase II/III.

Unlock this article instantly by becoming a free subscriber.

You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.

SIGN UP LOG IN BECOME A PREMIUM SUBSCRIBER