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Lexicon Loses Sota T1DM Formal Appeal

Lexicon Pharmaceuticals announced the FDA’s Office of New Drugs has denied Lexicon’s appeal of the CRL issued for sotagliflozin in T1DM. Lexicon’s stock fell ~15% in response to this news. In a conference call hosted shortly after the announcement, Lexicon outlined next-steps for sotagliflozin in T1DM and provided comments on additional indications and partnership opportunities. Below, FENIX provides highlights and insights from the call.

About The Author

Matthew Maryniak

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President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

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