NDA Resubmission for ZYNQUISTA
Completed resubmission of the NDA for ZYNQUISTA for glycemic control in people with type 1 diabetes and chronic kidney disease. The FDA Advisory Committee Meeting was held on October 31, and the company is working towards the PDUFA goal date of December 20, 2024.
Progress in Clinical Development
Phase III study for sotagliflozin in hypertrophic cardiomyopathy (HCM) is underway, and the Phase IIb study for LX9211 in diabetic peripheral neuropathic pain (DPNP) has completed enrollment screening earlier than anticipated.
Viatris Licensing Agreement
Exclusive licensing agreement completed for sotagliflozin outside the U.S. and Europe with Viatris, including a $25 million upfront payment and potential for $200 million in milestone payments.
Financial Position
Ended the quarter with $258.4 million in cash and investments, excluding the $25 million payment received from Viatris in the fourth quarter.