ARTICLE | Finance

Staccato stumble

FDA delay may increase regulatory risk for Alexza's Staccato platform

October 18, 2010 7:00 AM UTC

Alexza Pharmaceuticals Inc. (NASDAQ:ALXA) was slammed last week by a complete response letter that at best will mean a delay for lead program Adusuve Staccato loxapine (AZ-004), and at worst could increase the regulatory risk for other Staccato programs. The stock dropped $1.65 (54%) to $1.38 on Monday, after the letter was announced.

AZ-004 is a formulation of the typical antipsychotic loxapine that has shown efficacy in a pair of Phase III trials for rapid treatment of agitation in patients with schizophrenia or bipolar disorder...