Key Developments: Alexza Pharmaceuticals Inc (ALXA.O)

ALXA.O on Consolidated Issue listed on NASDAQ Capital Market

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Latest Key Developments (Source: Significant Developments)

Alexza Pharmaceuticals initiates Phase 2a Study of AZ-002
Thursday, 22 Jan 2015 09:00am EST 

Alexza Pharmaceuticals Inc:Initiated a Phase 2a study of AZ-002 (Staccato alprazolam), which is being developed for the management of epilepsy in patients with acute repetitive seizures (ARS).ARS occurs in a subset of patients with epilepsy who regularly experience breakthrough seizures, despite treatment with a regular regimen of anti-epileptic drugs.  Full Article

Alexza Pharmaceuticals Inc provides an update on the five post-EMA approval studies for ADASUVE
Thursday, 14 Aug 2014 09:00am EDT 

Alexza Pharmaceuticals Inc:Provided an update on its European Medicines Agency (EMA) post-approval studies for ADASUVE inhalation powder, pre-dispensed (loxapine).As part of the ADASUVE approval process with the EMA, Alexza is required to conduct five post-approval studies.A benzodiazepine interaction study - study completed and data submitted to the EMA.A controlled study to determine ADASUVE's effect on cardiac rhythms, or a thorough QTc study, with two doses of ADASUVE - study completed and data submitted to the EMA.A clinical program designed to evaluate the safety / efficacy of ADASUVE in agitated adolescent patients - the initial study in this program, a Phase 1 dose-ranging study, has been initiated in collaboration with Teva and the first patient dosed.A Post-Authorization Safety Study (PASS) - study has been initiated and the first patient dosed.A Drug Utilization Study (DUS) - study planned to be initiated in Q4 2014.  Full Article

Alexza Pharmaceuticals Inc announces launch of ADASUVE in Guatemala
Friday, 8 Aug 2014 09:00am EDT 

Alexza Pharmaceuticals Inc:Announced ADASUVE inhalation powder, pre-dispensed (loxapine) is available in Guatemala.Approval represents first ADASUVE approval in Latin America for Ferrer and Alexza.Ferrer is Alexza's commercial partner for ADASUVE in EU, Latin America and Commonwealth of Independent States countries.ADASUVE is first and only inhalation therapy for rapid control of mild-to-moderate agitation in adult patients with schizophrenia or bipolar disorder.Ferrer is expected to launch ADASUVE in additional EU and Latin American countries in 2014 and 2015.  Full Article

Alexza Pharmaceuticals Inc provides pipeline update
Thursday, 31 Jul 2014 04:15pm EDT 

Alexza Pharmaceuticals Inc:Provides update on pipeline and new product development efforts.In the second half of 2014, Alexza expects to initiate a Phase 2a study of AZ-002 (Staccato alprazolam), which is being developed for management of patients with acute repetitive seizures.Additionally, Alexza has identified two new Staccato -based product candidates for development - AZ-008 and AZ-009 - which will incorporate the active pharmaceutical ingredient ropinirole, dopamine agonist, into Alexza's proprietary Staccato system.Company plans to develop AZ-008 for the acute treatment of restless legs syndrome (RLS) and AZ-009 for hypomobility, or freezing, during "off periods" in Parkinson's disease (PD) patients.  Full Article

Alexza Pharmaceuticals Inc announces private placement of $45 mln of non-recourse notes
Wednesday, 19 Mar 2014 09:00am EDT 

Alexza Pharmaceuticals Inc:Closes a private placement to institutional investors of $45.0 million of non-recourse notes.Notes are secured by royalties and potential milestones from U.S. sales of ADASUVE inhalation powder. Alexza's commercial partner for ADASUVE in the U.S. is Teva Pharmaceuticals USA Inc.  Full Article

Alexza Pharmaceuticals Inc announces U.S. Commercial Launch of ADASUVE by Teva Pharmaceuticals
Monday, 3 Mar 2014 08:07am EST 

Alexza Pharmaceuticals Inc:Says U.S. commercial Launch of ADASUVE by Teva Pharmaceuticals.ADASUVE is the first and only orally inhaled medicine for the acute treatment of agitation associated with schizophrenia or bipolar I disorder in adults.ADASUVE new drug-device combination product provides rapid systemic delivery by inhalation of a thermally-generated aerosol of loxapine, a first generation antipsychotic, to the lung.  Full Article

Alexza Pharmaceuticals Inc announces Ferrer's Launch of ADASUVE (Staccato Loxapine) in Spain
Tuesday, 21 Jan 2014 09:05am EST 

Alexza Pharmaceuticals Inc:Says ADASUVE is now available in Spain through Grupo Ferrer Internacional S.A.Says Ferrer is Alexza's commercial partner for ADASUVE in the European Union (EU), Latin America, Russia and the CIS countries.Says in conjunction with this commercial introduction of ADASUVE in Spain by Ferrer, Alexza will receive a milestone payment of $1 mln.  Full Article

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