FiercePharma

After FDA setbacks, Lexicon slashes commercial operations in transition back to clinical-stage outfit

For many biopharmas, it takes years of hard work to transition from being a clinical-stage drugmaker to a commercial one. Companies rarely want to make the shift back. But after a years-long uphill ...
The American Journal of Managed Care

FDA Rejects Sotagliflozin for Type 1 Diabetes; Lexicon Shifts Focus

The FDA rejected sotagliflozin for type 1 diabetes and CKD. Lexicon will focus on LX9211 for diabetic neuropathic pain, with phase 2b data expected in 2025. Sotagliflozin's regulatory journey has been ...
Reuters

Lexicon Pharmaceuticals to lay off 60% of workforce after FDA setback

Nov 22 (Reuters) - Lexicon Pharmaceuticals (LXRX.O), opens new tab said on Friday it would reduce its workforce by about 60%, after the U.S. Food and Drug Administration noted deficiencies in its ...
Nasdaq

Lexicon Pharmaceuticals Receives Complete Response Letter from FDA for Zynquista™ NDA

Lexicon Pharmaceuticals announced that it received a complete response letter (CRL) from the FDA regarding its New Drug Application for Zynquista™ (sotagliflozin), which was proposed as an adjunct to ...
Reuters

Lexicon expects delay in FDA feedback on additional data for its diabetes drug

Sept 22 (Reuters) - Lexicon Pharmaceuticals (LXRX.O), opens new tab said on Monday the U.S. Food and Drug Administration requires more time to review the company's previously submitted additional data ...
Seeking Alpha

Lexicon Pharmaceuticals: 'Hold' As FDA Feedback Allows Pilavapadin For DPNP To Go Forward

The last time I spoke about Lexicon Pharmaceuticals, Inc. (LXRX) it was with respect to a Seeking Alpha article entitled "Advisory Panel Votes In Split Fashion For Lexicon's Drug: What does That Mean ...