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 ...
FiercePharma

Persistent Lexicon still working to get an audience with FDA on Type 1 diabetes prospect

Lexicon Pharmaceuticals won't take no for an answer. The Texas pharma—convinced of the value of its diabetes candidate sotagliflozin—has clapped back at its latest rejection from the FDA, asking to be ...
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 ...
Seeking Alpha

Lexicon Pharmaceuticals: Strategic Retrenchment Likely To Take Years To Show Results

Lexicon has pivoted back to a research-driven biotech model, abandoning internal drug marketing to focus on clinical development and out-licensing. Pilavapadin's upcoming Phase II readout is critical, ...
Seeking Alpha

Lexicon Pharmaceuticals Secures Key FDA Approval, But Heavy Lifting Remains

Lexicon Pharmaceuticals received FDA approval to market its heart failure drug Inpefa, as well as a broad label compared to rivals like AstraZeneca's Farxiga and Lilly's Jardiance. The company faces ...