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Re: biocqr post# 211079

Monday, 11/26/2018 9:36:52 AM

Monday, November 26, 2018 9:36:52 AM

Post# of 257556
ZFGN -41%—FDA clinical hold on ZGN-1061:

https://finance.yahoo.com/news/zafgen-provides-investigational-drug-application-120000875.html

The FDA cited the possibility of cardiovascular (CV) safety risk based on the Company’s prior compound and outlined multiple potential paths for moving forward, including nonclinical or clinical options, to address these concerns in the ongoing development of ZGN-1061. The Company plans to assess these options and request a Type A meeting with the Agency to discuss next steps with the program.


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