Lexicon Pharmaceuticals Knocked Back By The FDA's Rejection Of Zynquista [Seeking Alpha]
Sanofi - American Depositary Shares (SNY)
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Source: Seeking Alpha
Lexicon Pharmaceuticals Knocked Back By The FDA's Rejection Of Zynquista Summary The FDA has rejected Zynquista for Type 1 diabetes, and neither Sanofi nor Lexicon offered any insight as to the FDA's objections or the next steps in the process. A trial to prove out the risk management strategy cannot be ruled out, and would add at least a year to the timeline. Lexicon shares do still look undervalued, but between challenging commercial markets, early-stage development risk, and regulatory risk, this is not an easy buy call. Once again the FDA has shown that when it comes to new therapies for diabetes, particularly Type 1 diabetes, the agency believes in an abundance (perhaps an overabundance) of caution. To that point, SNY LXRX Given the 50/50 split on the AdComm vote and that aforementioned precautionary principle that has long dominated the agency’s approach to diabetes, I had estimated the odds of approval at only slightly better than 50/50 and I cannot say that the rejection was a
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