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Alexza Reports 2011 First Quarter Financial Results and Provides Business Update
Date:5/9/2011

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In January 2011, Alexza received the FDA minutes from the End-of-Review meeting with the FDA for the AZ-004 NDA in December 2010.  Based on the guidance received at the End-of-Review meeting, the Company believes the issues raised in the Complete Response Letter (CRL) are resolvable and Alexza anticipates resubmitting its AZ-004 NDA in July 2011.


  • On February 22, 2011, the Company completed a voluntary employee stock option exchange program to permit the Company's eligible employees to exchange some or all of their outstanding options to purchase the Company's common stock for a lesser number of new stock options with a new vesting period.  Stock options to purchase an aggregate of 2,128,430 shares of the Company's common stock, with exercise prices ranging from $2.38 to $11.70, were exchanged for stock option to purchase an aggregate of 808,896 shares of the Company's common stock with an exercise price of $1.23 per share.


  • Alexza announced that the British Journal of Psychiatry, a publication of the Royal College of Psychiatrists, in its January 2011 edition (198:51-58), published the results of the pivotal Phase 3 study evaluating AZ-004 (inhaled or Staccato loxapine) for the rapid treatment of agitation in patients with schizophrenia.


  • In April 2011, Alexza completed a Type C meeting with the FDA.  The primary purpose of this meeting was to discuss preliminary draft labeling and initial REMS program proposals.  The FDA granted this meeting at the Company's request, as a follow-on activity to discussions during Alexza's End-of-Review meeting held in December 2010.  In the information package submitted to the FDA in preparation for this guidance meeting, Alexza included updated draft labeling and a medication guide, and initial proposals for an AZ-004 REMS program, including a draft communication plan and
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  • SOURCE Alexza Pharmaceuticals, Inc.
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