FDA slaps a hold on an AML tri­al as Mark­er scraps a fail­ing ovar­i­an can­cer pro­gram, sink­ing shares

The FDA has placed a hold on a Phase II AML tri­al from the small im­muno-on­col­o­gy biotech Mark­er Ther­a­peu­tics. Mark­er dis­closed the is­sue two weeks af­ter re­spond­ing to FDA con­cerns, adding it to the Q3 re­lease Tues­day. The com­pa­ny al­so an­nounced it was scrap­ping a Phase II ovar­i­an can­cer pro­gram it de­ter­mined was un­like­ly to suc­ceed.

The agency’s con­cern cen­ters around two reagents used in man­u­fac­tur­ing for their tri­al for acute myeloid leukemia pa­tients who have re­ceived a stem cell trans­plant. The reagents are from third par­ties and not present in the fi­nal prod­uct, Mark­er said.

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Venture & Research Associate

Alexandria Real Estate Equities

San Francisco, CA, USA