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MacroGenics Says FDA Removed Partial Clinical Hold On MGD009 Program

MacroGenics, Inc. (MGNX) announced that FDA has lifted the partial clinical hold on its Phase 1 monotherapy and combination studies of MGD009, a B7-H3 × CD3 bispecific DART® molecule.

During the partial clinical hold, previously enrolled study participants were allowed to continue to receive drug at their pre-assigned dose. Enrollment of new patients in the U.S. has been cleared to proceed with these trials.

"The MacroGenics team worked diligently and rapidly to provide a comprehensive response to the FDA in late December. As a result, we have been able to resolve the partial clinical hold without significant delay to this clinical program," stated Scott Koenig, M.D., Ph.D., President and CEO of MacroGenics. "

MacroGenics previously announced on December 7, 2018, that the FDA had placed the program on partial clinical hold following MacroGenics' reporting of hepatic adverse events on the MGD009 trials to the FDA.

MGNX closed Friday's trading at $11.70, up $0.26 or 2.27%, on the Nasdaq.

MGD009 is a humanized, bispecific DART molecule that recognizes both B7-H3 and CD3 and has a prolonged serum half-life. B7-H3 is a member of the B7 family of molecules involved in immune regulation and is over-expressed on a wide variety of cancer cells, including cancer stem cells, as well as on the supporting tumor vasculature and underlying tissues, or stroma.

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