March 9 Quick Takes: Novartis’ canakinumab misses in Phase III NSCLC trial; plus Acadia, Cognito, Sagimet-Ascletis, GreenLight and Visus
Nearly four years after detecting an association between canakinumab therapy and decreased incidence of lung cancer in a clinical trial for atherosclerosis, Novartis AG (SIX:NOVN; NYSE:NVS) said the IL-1β inhibitor missed the primary endpoint in a Phase III non-small cell lung cancer (NSCLC) trial. Canakinumab did not increase overall survival as second- and third-line therapy in the 274-patient CANOPY-2 study. Canakinumab is marketed as Ilaris for several inflammatory and autoimmune diseases and is being evaluated in ongoing Phase III trials as adjuvant and first-line treatment for NSCLC.
Acadia falls on sDNA deficiencies
Acadia Pharmaceuticals Inc. (NASDAQ:ACAD) fell $20.76 (45%) to $25.02 on Tuesday after it said FDA identified undisclosed deficiencies in the sNDA application for Nuplazid pimavanserin to treat hallucinations and delusions associated with dementia-related psychosis. The PDUFA date is April 3. Nuplazid was approved in 2016 as the first drug to treat hallucinations and delusions associated with Parkinson’s disease psychosis...