Harlan Waksal, Kadmon CEO (Richard Drew, AP Images)

Kad­mon kicks off 're­al-time' NDA sub­mis­sion with an­oth­er look at 're­mark­able' chron­ic graft-ver­sus-host-dis­ease da­ta

Six months af­ter re­port­ing “knock-your-socks-off kind of re­sults” for its chron­ic graft-ver­sus-host-dis­ease drug from an in­ter­im analy­sis, Kad­mon is back with a fi­nal slate of da­ta that it said re­tained, if not am­pli­fied, the wow fac­tor.

The pos­i­tive topline da­ta have al­ready been sent to the FDA, the com­pa­ny said, as part of a pack­age filed un­der the Re­al-Time On­col­o­gy Re­view pro­gram. Kad­mon ex­pects to for­mal­ly sub­mit the NDA by the end of this year, com­plete with a fi­nal chunk of 12-month fol­low-on da­ta.

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