Navigation Links
Alexza Pharmaceuticals Completes End-of-Review Meeting With FDA for AZ-004 (Staccato® Loxapine) NDA
Date:1/18/2011

inties, which include, without limitation, risks related to the uncertainty of the FDA approval process and other regulatory requirements, and the timing of completion of the steps necessary for resubmission of the NDA for AZ-004.  Alexza may be unsuccessful in resolving the issues in the CRL and it may never receive marketing approval for AZ-004 or any of its product candidates.  These and other risks concerning Alexza's business are described in additional detail in the Company's Annual Report on Form 10-K for the year ended December 31, 2009, and the Company's other Periodic and Current Reports filed with the Securities and Exchange Commission including the risks under the headings: "Regulatory authorities may not approve our product candidates even if they meet safety and efficacy endpoints in clinical trials.", "We have a history of net losses. We expect to continue to incur substantial and increasing net losses for the foreseeable future, and we may never achieve or maintain profitability.", and "We will need substantial additional capital in the future. If additional capital is not available, we will have to delay, reduce or cease operations.".  Forward-looking statements contained in this announcement are made as of this date, and we undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.


'/>"/>
SOURCE Alexza Pharmaceuticals, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6

Related medicine technology :

1. Alexza Pharmaceuticals Provides Regulatory Update for AZ-004 (Staccato® Loxapine)
2. Alexza Pharmaceuticals Reports 2010 Third Quarter Financial Results and Provides Business Update
3. Alexza Pharmaceuticals to Announce 2010 Third Quarter Financial Results on November 9, 2010
4. Alexza Pharmaceuticals Reacquires U.S. and Canadian Rights for AZ-004 (Staccato® Loxapine)
5. Valeant Pharmaceuticals Announces That Alexza Pharmaceuticals Has Received a Complete Response Letter for AZ-004 (Staccato® Loxapine) Inhalation Aerosol NDA
6. Alexza Pharmaceuticals Receives Complete Response Letter for AZ-004 (Staccato® Loxapine) NDA
7. Alexzas Staccato® Nicotine Licensed to Cypress Bioscience
8. Alexza Pharmaceuticals to Present at Bank of America Merrill Lynch 2010 Specialty Pharmaceuticals Conference
9. Alexza Pharmaceuticals Appoints Joseph L. Turner to Its Board of Directors
10. Alexza to Announce 2010 Second Quarter Financial Results on Monday, July 26, 2010
11. Alexza Pharmaceuticals Updates Staccato® Pipeline and Outlines Pipeline Development Strategy
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:11/22/2014)... DENVER , Nov. 21, 2014 Statistics ... drinking and drunk driving increase astronomically during the holidays, ... Wednesday" in many cities. The data, ... Alcohol Monitoring Systems as part of their annual ... paints a picture of high-risk drinking and increased ...
(Date:11/22/2014)... BETHLEHEM, Pa. , Nov. 21, 2014 /PRNewswire/ ... drug eluting devices, has developed and manufactured a ... Institute (LPRI), the Research and Development arm of ... Vice President of Project Management at Particle Sciences, ... Particle Sciences utilizing our material sciences and modeling ...
(Date:11/22/2014)... , Nov. 21, 2014 Many power ... the growing influence of patients in the biopharmaceutical ... interactions. Now, more than ever, understanding how to ... medical products is essential. According ... LLC, benchmarked companies spent about two-thirds of their ...
Breaking Medicine Technology:Alarming Stats Show Holiday Drinking an Issue for Many 2Particle Sciences' Clinical Trial Supplies Group Manufactures Innovative Vaginal Ring 2New Report Details Importance of Adopting a "Patient Journey" Framework in Marketing 2
... Study Ingredient,s, Impact on North Americans, NEW ... of,Japan today announced that it has selected world-renowned Cardiologist ... KGK Synergize Inc.,to launch a new clinical trial to ... lipid management and the reduction of cardiovascular,risk factors in ...
... a 52-week phase 3,study (LEADTM 3) of Novo ... GLP-1 analog, were published online today in The ... produces statistically,significant and sustained improvements in blood sugar ... compared with glimepiride, a widely used,oral anti-diabetic drug. ...
Cached Medicine Technology:Leading Cardiologist Joins Ontario Research Firm to Conduct New Clinical Trial on the Effect of Pantethine on Cholesterol Levels 2Leading Cardiologist Joins Ontario Research Firm to Conduct New Clinical Trial on the Effect of Pantethine on Cholesterol Levels 3Data from One-Year Liraglutide Phase 3 Study Published Online in The Lancet 2Data from One-Year Liraglutide Phase 3 Study Published Online in The Lancet 3
(Date:11/23/2014)... 23, 2014 The report, “Market ... to 2020 - Asia-Pacific” provides quantitative analysis of ... segments: minimally invasive body contouring devices, non-invasive body ... includes market size data by revenue and volume ... countries: China, Japan, South Korea, Australia and India. ...
(Date:11/23/2014)... (PRWEB) November 23, 2014 Nearly ... heart attacks, strokes, deep vein thrombosis and other ... a federal multidistrict litigation (MDL) underway in the ... , Court documents updated on November 17th ... (JPML) show the filing of 259 lawsuits against ...
(Date:11/23/2014)... Locks-Magnetic.com, a notable magnetic locks maker, has released ... products are available at low rates up to 30% ... the new emergency doors. The emergency door adopts fireproof ... from several colors. All of the products are top-quality ... is not as easy as many people think. ...
(Date:11/23/2014)... SWAccessControl.com's high quality access control power ... company has announced its new collection of power suppliers. ... high quality power suppliers. All the new models come ... offer lasts until Dec. 20, 2014. , SWAccessControl.com has ... been supporting it for a long time. It is ...
(Date:11/23/2014)... 2014 Asher Milgrom, is a ... Wellness was recently featured on International Business ... and CEO of American Medical Aesthetics & Wellness, also ... a full scholarship to attend an M.D./Ph.D program at ... the University of Chicago, where his field of study ...
Breaking Medicine News(10 mins):Health News:Aesthetic Lasers and Energy Devices Market in APAC (China, Japan, South Korea, Australia and India) to 2020 2Health News:Aesthetic Lasers and Energy Devices Market in APAC (China, Japan, South Korea, Australia and India) to 2020 3Health News:Aesthetic Lasers and Energy Devices Market in APAC (China, Japan, South Korea, Australia and India) to 2020 4Health News:Testosterone Lawsuits Approach 260 in Illinois Federal Court Litigation, Bernstein Liebhard LLP Reports 2Health News:Testosterone Lawsuits Approach 260 in Illinois Federal Court Litigation, Bernstein Liebhard LLP Reports 3Health News:Cheap Access Control Power Supplies Online Now at SWAccessControl.com, Special Offer Until Dec. 20, 2014 2Health News:Asher Milgrom Is the Founding Doctor of AMA Skincare and Is Featured in the International Business Times 2Health News:Asher Milgrom Is the Founding Doctor of AMA Skincare and Is Featured in the International Business Times 3Health News:Asher Milgrom Is the Founding Doctor of AMA Skincare and Is Featured in the International Business Times 4
... Island Residents PROVIDENCE, R.I., March 26 ... them fight off rising healthcare costs. A new statewide discount ... to officially launch today. RIRx , which is free ... Generic medications (average savings are roughly 30%). Rhode Island residents ...
... N.C., March 26 Abusing real-time communication tools like ... ability of sales reps to engage with physicians."A lot ... them more efficient," stated a sales executive in a ... COUNCIL. "In reality, they,re so distracted by doing four ...
... and SYDNEY, Australia, March 26 Thoratec Corporation (Nasdaq: ... circulatory support therapies to save, support and restore failing ... ; ASX: HIN), which develops and manufactures miniaturized implantable ... Request for Additional Information, or a "second request," from ...
... Debt Facilities; Support Robust GrowthALISO VIEJO, Calif., March 26 ... ), a premier anatomic pathology and molecular testing services ... today that it has entered into a $50 million ... Partners , a multi-stage venture capital firm with $8.4 ...
... of Medicine have been named early career scientists by the ... M.D., Ph.D., and Sinisa Urban, Ph.D., all will remain faculty ... provide research funding and salary for the next six years. ... for being recognized by Hughes for the quality of their ...
... for Umbilical Cord Blood BankingSAN BRUNO, Calif., March 26 ... leader in the collection and preservation of newborn stem ... legislation introduced yesterday by U.S. Representatives Ron Kind (D-WI), ... (D-NJ) and Mike Thompson (D-CA) entitled the "Family Cord ...
Cached Medicine News:Health News:Free Prescription Drug Card Launched in Rhode Island 2Health News:Sales Force Effectiveness: Less Texting, More Engagement 2Health News:Thoratec and HeartWare Receive Request for Additional Information From Federal Trade Commission 2Health News:Thoratec and HeartWare Receive Request for Additional Information From Federal Trade Commission 3Health News:Thoratec and HeartWare Receive Request for Additional Information From Federal Trade Commission 4Health News:Thoratec and HeartWare Receive Request for Additional Information From Federal Trade Commission 5Health News:Clarient Entered Into Private Placement of Up To $50 Million in Convertible Preferred Stock With Oak Investment Partners 2Health News:Clarient Entered Into Private Placement of Up To $50 Million in Convertible Preferred Stock With Oak Investment Partners 3Health News:Clarient Entered Into Private Placement of Up To $50 Million in Convertible Preferred Stock With Oak Investment Partners 4Health News:Clarient Entered Into Private Placement of Up To $50 Million in Convertible Preferred Stock With Oak Investment Partners 5Health News:Clarient Entered Into Private Placement of Up To $50 Million in Convertible Preferred Stock With Oak Investment Partners 6Health News:Clarient Entered Into Private Placement of Up To $50 Million in Convertible Preferred Stock With Oak Investment Partners 7Health News:Clarient Entered Into Private Placement of Up To $50 Million in Convertible Preferred Stock With Oak Investment Partners 8Health News:Three Johns Hopkins researchers named Howard Hughes Medical Institute early career scientists 2Health News:Cord Blood Registry Supports Family Cord Blood Banking Act 2Health News:Cord Blood Registry Supports Family Cord Blood Banking Act 3
... number is a new product ... Cornings product number. If showing ... under the old Sigma-Aldrich number ... for assistance. Color: ...
... opening spermit performing of plugs and allow precise ... easy identification and sorting. Colored graduations are enameled ... pipet is calibrated "To Deliver" its total capacity ... Dim: O.D. L 8 350 mm ...
Corning 7077B L 215 mm volume 5.0 0.1 mL...
... 0.5mL PYREX glass pipets are ... blow-out and offer long, slender, ... go faster and easier. All ... fire polished tips for burr-free, ...
Medicine Products: