FDA slaps par­tial hold on Macro­Gen­ics for bis­pe­cif­ic can­cer tri­als as liv­er tox spurs safe­ty fears

Leery about signs of liv­er tox­i­c­i­ty among pa­tients tak­ing a B7-H3 × CD3 bis­pe­cif­ic un­der de­vel­op­ment at Macro­Gen­ics $MGNX, the FDA has slapped a par­tial hold on the ear­ly-stage pro­gram.

The par­tial hold — which af­fects their monother­a­py tri­al as well a com­bi­na­tion ef­fort with their own PD-1 check­point MGA012, part­nered with In­cyte — will stop re­searchers from re­cruit­ing new pa­tients, but peo­ple who have al­ready signed up can con­tin­ue treat­ment.

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