Zyquista T1DM CRL stands (Lexicon Q4 ’19 Earnings Update); Jardiance CKD Fast Track Designation

Lexicon hosted its Q4 ’19 earnings call (press release) and provided brief updates on the Zyquista T1DM CRL appeal as well as the T2DM Ph3 development program. Additionally, Lilly announced the FDA’s fast track designation to Jardiance in chronic kidney disease (press release). Of note, CDER reaffirmed the FDA’s decision on the Zyquista T1DM CRL, stating the NDA application in T1DM could not be approved in its current form. Below are the key highlights and insights from Lexicon’s earnings call as well as the Jardiance CKD fast track designation, especially in the context of other ongoing renal outcomes trials.

About The Author

Matthew Maryniak

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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