Alexza Gains on GMP Certification May Not Last Through Trading Session

Alexza Pharmaceuticals (NASDAQ:ALXA) reported this morning that the company’s Adasuve manufacturing facility in Mountain View, CA received a Certificate of GMP (Good Manufacturing Practice) Compliance from the European Union. Although the certification looks good for the company, Alexza is no closer to EU approval of Adasuve. The drug, which is being developed as a treatment for schizophrenia and bipolar disorder, has a troubled history with both the FDA and the European Medicines Agency. After originally submitting a New Drug Application in December of 2009, Adasuve received two Complete Response Letters in the following three years and faced repeated delays in the process based on the FDA’s safety concerns. The news is rallying the stock, which is up 8% in premarket trading. Expect shares to give back gains however, even as early as later in the day, as the certification this morning is not the most significant issue in Adasuve’s approval process. The company expects a decision from the FDA, and possibly the EMA, in December of this year.