Alexza Pharmaceuticals (NASDAQ: ALXA) announced after the market close on Thursday that the FDA has accepted the company’s [resubmitted] ADASUVE New Drug Application (NDA) with a PDUFA date of Dec. 21, 2012. After an initial 20% drop earlier, Alexza is slowly regaining investor confidence. ADASUVE is Alexza’s lead program developed to treat agitation in bipolar disorder and schizophrenia. The company originally submitted the NDA in December of 2009 and has been in a back-and-forth resubmission process since – two complete response letters based on safety concerns. The drug is an antipsychotic inhalant that, while highly effective, has shown problems in patients with lung conditions (source).
Alexza skyrocketed from $.50 to $4.00 levels in June with the announcement of resubmission and positive outlook on approval from management. The news should lift shares heading into the PDUFA date, notwithstanding abnormal volatility pertaining to recent news.