Lexicon Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has acknowledged the resubmission of its New Drug Application (NDA) for Zynquista? (sotagliflozin) as an adjunct to insulin therapy for glycemic control in adults with type 1 diabetes and chronic kidney disease (CKD). The FDA indicated that it considers the resubmission to be a complete response to the FDA?s 2019 action letter regarding the sotagliflozin NDA for type 1 diabetes, providing a Prescription Drug User Fee Act (PDUFA) goal date of December 20, 2024.
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5-day change | 1st Jan Change | ||
2.135 USD | -4.26% |
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+31.19% | +39.76% |
07-16 | FDA Sets Target Action Date for Lexicon Pharmaceuticals' NDA Resubmission for Sotagliflozin | MT |
07-16 | FDA Sets PDUFA Goal Date for Lexicon Pharmaceuticals' NDA Resubmission for Sotagliflozin | MT |
Stocks mentioned in the article
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Capi.
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3,210 JPY | -5.87% | -6.82% | 1.44B | ||
2.135 USD | -4.26% | +31.19% | 806M | ||
![Consensus](/images/consensus_flch.gif)
EPS Revisions
1st Jan change | Capi. | |
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+39.76% | 806M | |
+19.22% | 126B | |
+22.79% | 118B | |
+23.26% | 27.87B | |
-19.35% | 20.95B | |
-15.13% | 16.92B | |
-14.52% | 16.18B | |
+9.51% | 14.84B | |
-46.10% | 14.79B | |
+50.47% | 14.08B |
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- Lexicon Pharmaceuticals, Inc. Receives PDUFA Goal Date for Sotagliflozin Type 1 Diabetes NDA Resubmission