Tag Archive for: serious adverse event (SAE)

Shares of MacroGenics, Inc. are falling in pre-market trading after the company announced late Friday that it has shuttered a Phase II study of its investigational drug enoblituzumab as part of a combination therapy for head and neck cancer following seven reported deaths.

The U.S. Food and Drug Administration has placed Astellas Pharma’s Phase I/II FORTIS trial on clinical hold after one of its study participants experienced a serious adverse event (SAE).