Regulatory milestones

Alexza Pharmaceuticals Inc. (NASDAQ:ALXA) was off $0.43 to $5.79 on Friday after FDA approved an NDA for Adasuve Staccato loxapine to treat acute agitation in adults with schizophrenia or bipolar disorder with a boxed warning and a REMS. The label includes a boxed warning of an increased risk of bronchospasm and increased mortality in elderly patients with dementia-related psychosis. The REMS includes provisions to ensure that the product is administered only in a healthcare facility that has access on-site to equipment and personnel trained to manage acute bronchospasm.