Alexza Pharmaceuticals ($ALXA) says it has had a chance to sit down with the FDA to discuss its stalled application for AZ-004, an inhaled, fast-acting treatment for the management of schizophrenia and bipolar disorder. And the developer came away with the sense it can resolve all the agency's issues and refile for an approval in July.
The new timetable did little to relieve the anxieties of its shareholders, however. The biotech's shares initially slid more than 30 percent on the news, but the stock steadied by mid-morning, with shares down 15 percent.
Back in October, Alexza shares plunged after regulators held back an approval on AZ-004, flagging early-stage data showing patients with asthma and other respiratory conditions--as well as some healthy people--complained of decreased lung function after using the inhaler/therapy. And that includes some people who used the inhaler with a placebo. The device is designed to deliver a quick burst of the antipsychotic loxapine, which has been in use for years.
AZ-004 is Alexza's lead drug program, which will be marketed by Biovail in the U.S. and Canada, provided they can gain regulatory approval.
- check out the Alexza release