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Re: DewDiligence post# 222702

Monday, 12/10/2018 11:55:37 AM

Monday, December 10, 2018 11:55:37 AM

Post# of 253152
MGNX -27% on partial clinical hold announced Friday evening (#msg-145325096); discussion:

http://www.evaluate.com/vantage/articles/news/macrogenics-safety-scare-could-be-contagious

The sell-side did its best to reassure the markets that the clinical hold on Macrogenics’ MGD009 had nothing to with either the project’s target, B7-H3, or the company’s bispecific technology. But one of these seems likely to be at fault for the liver toxicity observed…

Macrogenics blamed the liver enzyme elevations on cytokine release syndrome due to increased T-cell activity, which can also be a side effect of CAR-T therapy. In addition, the company pointed out that the liver signals seen with MGD009 were resolved quickly after the affected patients were given Actemra.

…However, the US FDA might not agree with Macrogenics’ benign interpretation of the adverse events, and a longer delay could drag down the company along with others in the bispecific arena too, perhaps.


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