The FDA has once again declined to approve Lexicon Pharmaceuticals Inc.'s (LXRX) Zynquista, proposed as an adjunct to insulin therapy for glycemic control in adults with type 1 diabetes and chronic kidney disease.
The regulatory agency's decision is in line with the FDA panel's negative vote. In October of this year, an FDA panel that scrutinized Zynquista voted against it, saying that the drug's benefits do not outweigh the risks.
This was the company's second attempt to secure FDA approval. The FDA declined to approve Zynquista in March 2019 too.
Zynquista received EU approval in April 2019 for type 1 diabetes but was withdrawn in March 2022 at the request of its marketing rights holder, Guidehouse Germany GmbH.
The company is advancing LX9211 for diabetic neuropathic pain in a phase IIb study, dubbed PROGRESS. Topline data from this trial is anticipated in Q1 2025.
LXRX closed Friday's trading at $0.71, down 1.23%. In premarket trading, the stock is down another 6.25% at $0.67.
For comments and feedback: editorial@rttnews.com