Shares of Alexza Pharmaceuticals Inc. (ALXA) rose as much as 19 percent in intraday trading on Friday before closing 11.45% higher at $5.84, following the EU panel recommending approval of its anti-agitation product Adasuve.
The EU panel's opinion will be conveyed to the European Commission, the ultimate authority for granting marketing authorization to a drug, and a final decision on Adasuve is expected in the first quarter of 2013.
The next eagerly-awaited event is the FDA's decision on Adasuve, which is scheduled for December 21, 2012.
Adasuve is a drug-device combination which uses Alexza's proprietary Staccato system to deliver the FDA-approved antipsychotic drug Loxapine into the patient's lungs.
According to Alexza, the Staccato system helps the drug to be quickly absorbed through the lungs into the bloodstream, providing therapeutic relief that is comparable to intravenous administration, but with greater ease, patient comfort and convenience.
This is Adasuve's third go-around with the FDA. The regulatory agency had twice rejected the product - in October 2010 and May 2012.
In the complete response letter issued in May of this year, the deficiencies identified were only medical device-specific and no clinical or safety issues were raised.
Will the third time be a charm? Stay tuned...
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June 05, 2026 16:18 ET A busy week for economic news flow saw a slew of reports being released that reflected the trends in the U.S. labor market. In Europe, economic growth and inflation data gained attention as the European Central Bank and Bank of England head for policy session later in the month. In Asia, the monetary policy session of the Indian central bank was in focus as the country, a major oil importer, reels under the pressures of a weaker rupee and rising inflation.