As elec­tion storm gath­ered, Ar­row­head drops word about a clin­i­cal hold

As every­one’s at­ten­tion was be­ing com­mand­ed by the big pres­i­den­tial vote Tues­day night, Ar­row­head Phar­ma­ceu­ti­cals $AR­WR chose to put out word that its lead pro­gram has been put on hold by the FDA.

The Pasade­na, CA-based biotech says that reg­u­la­tors clamped down on the Phase II for ARC-520, its treat­ment for he­pati­tis B, af­ter the deaths of pri­mates in an on­go­ing tox­i­col­o­gy study. That study in­volved high­er dos­es than what is be­ing used in hu­man stud­ies, us­ing its EX1 de­liv­ery ve­hi­cle. Ar­row­head did not ex­plain how many of the pri­mates died, but said in­ves­ti­ga­tors did not know what caused the deaths, which are un­der in­ves­ti­ga­tion.

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