Alexza Pharmaceuticals Inc. (NASDAQ: ALXA) is trading at $4.52, gaining 0.55 or (13.85%) as of 11:41AM EDT on 2.5 Million shares, with a morning high of $4.99. The Company reported Friday that it has resubmitted its ADASUVE New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in response to a Complete Response Letter (CRL) received in May 2012. ADASUVE is being developed for the acute treatment of agitation associated with schizophrenia or bipolar I disorder in adults. In the coming weeks, Alexza expects to hear from the FDA regarding the completeness of the resubmitted NDA, the classification of the resubmission (Class 1 or Class 2) and what the new Prescription Drug User Fee Act (PDUFA) goal date will be. Class 1 and Class 2 resubmissions have targeted review periods of 2 months and 6 months, respectively.
Synta Pharmaceuticals Corp. (Nasdaq: SNTA) trading at $7.88, gaining 0.64 or (8.84%) 11:38AM EDT. The stock has a morning high of $8.50 on volume of over 2. 1 Million shares.
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