Jan. 14 Quick Takes: Lexicon rises on NDA timeline for heart failure program; plus: FDA COVID reports and updates from BeiGene, Merck, Bayer
Lexicon Pharmaceuticals Inc. (NASDAQ:LXRX) gained $4.13 (105%) to $8.05 Thursday after saying data from its Phase III SOLOIST and SCORED trials of sotagliflozin could support an NDA submission as early as this year to reduce the risk of cardiovascular death, hospitalization for heart failure and urgent heart failure visits in adult patients with Type II diabetes who have either worsening heart failure or other risk factors. The dual inhibitor of SGLT1 and SGLT2 is approved in the EU as Zynquista an adjunct to insulin to improve blood sugar control in adults with Type I diabetes.
BeiGene’s PD-1 approved in China for first-line NSCLC
BeiGene Ltd. (NASDAQ:BGNE; HKEX:6160) said China’s National Medical Products Administration approved tislelizumab in combination with chemotherapy as first-line treatment for patients with advanced squamous non-small cell lung cancer (NSCLC), marking the PD-1 inhibitor’s third approved indication in China. On Monday, Novartis AG (NYSE:NVS; SIX:NOVN) gained rights to tislelizumab in North America, Europe and Japan for $650 million up front and up to $1.6 billion in milestones, plus royalties. ...