MOUNTAIN VIEW, Calif. (AP) -- Shares of Alexza Pharmaceuticals Inc. surged Friday after the company said it filed a new marketing application for its agitation drug Adasuve.
Adasuve is an inhaled drug designed to treat acute agitation caused by schizophrenia or bipolar disorder. In May the Food and Drug Administration told Alexza it needed to fix problems at a manufacturing facility before FDA would consider approving its latest application. Alexza does not have any products on the market, and Adasuve is its most advanced drug candidate.
Shares jumped $1.23, or 44.9 percent, to close at $3.97.
In the next few weeks, Alexza expects the FDA to tell the company if its new application responds to all the issues the FDA raised in May. The agency will also inform Alexza how long it will take to complete its review of the new application. Alexza expects the FDA to finish reviewing the application in either a two or six-month timeframe.
Alexza is also discussing Adasuve, or staccato loxapine, with a European Union regulatory panel. In March that panel sent the company a list of questions in response to its application in the EU. Those questions included "major objections" related to conclusions the company is drawing based on late-stage clinical trial data, aspects of the company's risk management plan, and manufacturing issues.
Alexza met with the advisory panel in May. It expects to submit a response early in the third quarter.
- Food and Drug Administration