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News Breaks
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October 21, 2009
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| 08:41 EDT |  | ALXA |
| theflyonthewall.com: | Alexza Pharmaceuticals attractive at current levels, says Wedbush | | After speaking with management, Wedbush believes Alexza's loxapine NDA filing remains on target for early next year. The firm thinks the company's increased cash position, NDA filing and partnering discussions suggest momentum is positive and thinks shares are attractive at current levels. :theflyonthewall.com |
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February 13, 2012
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| 08:16 EDT |  | ALXA |
| theflyonthewall.com: | Alexza Pharmaceuticals receives day 80 assessment report for ADASUVE MAA | | Alexza Pharmaceuticals announced that it has received preliminary feedback, the Day 80 Assessment Report, from the European Medicines Agency, or EMA, regarding its Marketing Authorization Application, or MAA, for Adasuve, or Staccato loxapine. The ADASUVE MAA seeks approval for the rapid control of agitation in adult patients with schizophrenia or bipolar disorder. The Day 80 Assessment Report for ADASUVE outlines major objections pertaining to the extrapolation of the Phase 3 study population to the intended patient population, pulmonary safety in patients with active airways disease and recommendations to address this issue via the risk management plan, other aspects of the risk management plan, and the need to obtain an EU GMP certificate for the Alexza manufacturing facility and commercial manufacturing process. The next official EMA communication Alexza expects to receive will be the Day 120 notification and report, where the CHMP finalizes the list of review questions, the overall conclusions of scientific data and a listing of outstanding issues. Alexza will be working with Grupo Ferrer, its partner for ADASUVE in the EU and other territories, to provide to the European authorities a comprehensive explanation of any of the remaining questions that the Day 120 assessment report may contain. Alexza completed a Pre-Approval Inspection of its GMP commercial manufacturing facility by the FDA in December 2011, and Alexza believes it is well prepared for the EMA inspection of its facility. :theflyonthewall.com |
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