Lexicon Announces Receipt of Complete Response Letter for Zynquista™ (sotagliflozin)
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Lexicon Pharmaceuticals received a complete response letter from the FDA for Zynquista, a drug for type 1 diabetes and CKD. The company had already decided to halt launch preparations for Zynquista and focus on its clinical development pipeline.

December 20, 2024 | 9:45 pm
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Lexicon Pharmaceuticals received a complete response letter from the FDA for Zynquista, a drug for type 1 diabetes and CKD. The company had already decided to halt launch preparations for Zynquista and focus on its clinical development pipeline.
The FDA's complete response letter indicates that Zynquista will not be approved at this time, which is a setback for Lexicon Pharmaceuticals. However, the company had already planned to discontinue launch preparations, which may mitigate the negative impact. The focus on the clinical development pipeline suggests a strategic pivot, but the immediate reaction is likely negative due to the regulatory setback.
CONFIDENCE 90
IMPORTANCE 80
RELEVANCE 100