Navigation Links
Savient Pharmaceuticals Reports Second Quarter 2009 Financial Results
Date:8/10/2009

s."

Operational Key Events:

  • Raised $31.0 million from a registered direct offering that yielded $29.0 million in cash, net of $2.0 million of offering costs

  • Elected Ginger D. Constantine, M.D. to the Company's Board of Directors

  • FDA appointed Arthritis Advisory Committee recommended marketing approval for KRYSTEXXA

  • Presented six abstracts (two oral presentations and four posters) about KRYSTEXXA at the European League Against Rheumatism (EULAR) 2009 Annual Congress addressing various aspects of treatment failure gout.

  • Received a complete response letter from the FDA on July 31, 2009 stating that the FDA cannot at this time approve the BLA for KRYSTEXXA as a treatment for chronic gout in patients refractory to conventional therapy. The complete response letter cited deficiencies with the CMC section of the BLA and also provided the current draft of the proposed labeling and further guidance regarding a Risk Evaluation and Mitigation Strategy (REMS). We expect to resubmit our BLA to the FDA in early 2010 to respond to the FDA's complete response letter.

  • Received notification from the FDA of a tentative meeting date scheduled for mid-September 2009 to discuss the complete response letter issued by the FDA in response to the "Type A" Meeting request filed by the Company.

Financial Results of Operations for the Three Months Ended June 30, 2009

Total revenues for the second quarter of 2009 were $0.7 million compared with $0.4 million for the second quarter of 2008, an increase of $0.3 million. The increase is primarily the result of higher product sales of oxandrolone, our authorized generic product that promotes weight gain f
'/>"/>

SOURCE Savient Pharmaceuticals, Inc.
Copyright©2009 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6 7 8 9 10 11 12 13 14

Related medicine news :

1. Savient Pharmaceuticals to Present at the Credit Suisse Phoenix Healthcare Conference on November 13th
2. Savients Board of Directors Forms a Board Committee to Oversee the Regulatory and Pre-Launch Activities for Pegloticase
3. Savient Pharmaceuticals to Present at the 27th Annual J.P. Morgan Healthcare Conference on January 14th
4. Savient Pharmaceuticals Reports Fourth Quarter and Year-End 2008 Financial Results
5. Savient Pharmaceuticals to Present at The Cowen and Company 29th Annual Healthcare Conference on March 17, 2009
6. Savient Pharmaceuticals Receives Complete Response Letter from U.S. Food and Drug Administration for KRYSTEXXA(TM)
7. Arena Pharmaceuticals to Present at the NewsMakers in the Biotech Industry Conference
8. Schering-Plough/Merck Pharmaceuticals Announce FDA Filing Acceptance of New Drug Application for Loratadine/Montelukast Tablet
9. Provectus Pharmaceuticals, Inc. Begins Phase 2 Clinical Trial for Metastatic Melanoma
10. Idenix Pharmaceuticals to Present at Two Upcoming Investor Conferences
11. Vista Partners Updates Coverage on Tapestry Pharmaceuticals
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/15/2014)... New York (PRWEB) September 15, 2014 ... Bard, Inc. continue to move forward in the federal ... District of West Virginia, Bernstein Liebhard LLP reports. According ... a Final Order on September 10th that provides for ... Order notes that none of the affected plaintiffs has ...
(Date:9/15/2014)... large cohort analysis from the prospective Prostate, Lung, Colorectal ... who had moderate baldness affecting both the front and ... at a 40% increased risk of developing aggressive prostate ... poorer prognosis relative to non-aggressive prostate cancer) later in ... no significant link between other patterns of baldness and ...
(Date:9/15/2014)... The White House has recently begun shifting ... jail and prison and toward helping them access addiction ... positive change. , The nation is currently grappling with ... to an article from The Washington Post , ... away from using the criminal justice system to address ...
(Date:9/15/2014)... By Maureen Salamon ... (HealthDay News) -- Pediatricians prescribe antibiotics about twice as ... and throat infections, a new study indicates. More ... children and teens may be unnecessary, according to researchers ... excess antibiotic use not only fails to eradicate children,s ...
(Date:9/15/2014)... shown that certain brain regions are associated with ... decision-making. , How and where these specific abilities ... cognition is still under investigation. However, researchers at ... St. Louis, Missouri, believe that several hub regions ... function as an integrated network. , In research ...
Breaking Medicine News(10 mins):Health News:C.R. Bard Transvaginal Mesh Lawsuits Move Forward, With Issuance of New Order in Federal Multidistrict Litigation, Bernstein Liebhard LLP Reports 2Health News:C.R. Bard Transvaginal Mesh Lawsuits Move Forward, With Issuance of New Order in Federal Multidistrict Litigation, Bernstein Liebhard LLP Reports 3Health News:Certain form of baldness at age 45 linked to higher risk of aggressive prostate cancer 2Health News:White House Shifts Policy on Drugs 2Health News:Kids Prescribed Antibiotics Twice as Often as Needed, Study Finds 2Health News:Kids Prescribed Antibiotics Twice as Often as Needed, Study Finds 3Health News:Network measures predict neuropsychological outcome after brain injury 2
... its new patient-education website, www.CLIclinicalstudy.com , is now “live”. ... enrolling in the Company’s clinical trial and their referring physicians ... underlies it, and the location of the study’s sites. ... ...
... help consumers get,accurate, dependable information about healthcare ... support consumer,engagement and improved quality in healthcare, ... consumer-focused, internet-based public,reporting. These guidelines will assist ... in an evidence-based and,consumer-friendly format that can ...
... (October 26, 2008) A single administration of a novel, ... that were more than 20 times higher than those ... according to a study by NanoBio Corporation. The new ... produce this effect. , Results of the study are ...
... blood that was 29 days or older faced twice the ... who receive a transfusion of stored blood that is 29 ... or more serious infections compared to those who get "fresher" ... that current U.S. regulations set the upper limit for blood ...
... of candy, ST. LOUIS, Oct. 28 The ... year, and a sizeable portion of that indulgence,is eaten ... will,simply create an expanded beltline. However, for the more ... can pose more,tricky consequences., To help ease candy ...
... Resources to Prevent Millions in Lost Wages, SAN ... of the flu are reported annually, financially challenging working,families ... days. QuickHealth meets,the challenge by providing updated information and ... to clarify treatment options and to help,them make better ...
Cached Medicine News:Health News: Harvest Technologies Announces Patient Education Website, www.CLIclinicalstudy.com : Supports first randomized, placebo-controlled clinical trial in the U.S. using autologous adult stem cells to treat patients with end-stage Critical Limb Ischemia 2Health News:NQF Endorses Guidelines for Consumer-Focused Public Reporting 2Health News:NQF Endorses Guidelines for Consumer-Focused Public Reporting 3Health News:NQF Endorses Guidelines for Consumer-Focused Public Reporting 4Health News:NQF Endorses Guidelines for Consumer-Focused Public Reporting 5Health News:New intranasal influenza vaccine triggers robust immunity with significantly less antigen 2Health News:Older Blood Boosts Chances of Infection in Transfusion Patients 2Health News:Older Blood Boosts Chances of Infection in Transfusion Patients 3Health News:Orthodontists Offer Sweet Incentives for Tricky Halloween Treats 2Health News:Orthodontists Offer Sweet Incentives for Tricky Halloween Treats 3Health News:75 Million Missed Work Days Expected This Flu Season 2Health News:75 Million Missed Work Days Expected This Flu Season 3
(Date:9/15/2014)... Research and Markets has announced the ... Diagnostic Tests, 9th Edition" report to their offering. ... clinical testing market and all of its segments, providing customers ... Companies For Business Planning. This is the ninth ... of 2013 and early 2014. New entrants, new technologies have ...
(Date:9/15/2014)... , Sept. 15, 2014  MedExpress Urgent Care, a national ... now offering flu shots for ages four and up at ... patients to get their flu shot early. ... the end of June, making late summer and early fall ... season. MedExpress Vice President of Provider and Clinical Quality, ...
(Date:9/15/2014)... CITY , Sept. 15, 2014 /PRNewswire-iReach/ -- ... invasive surgical (MIS) visualization products, is pleased to ... for its quality management system (QMS) through BSI, ... important step in Olive Medical complying with all ... devices.  It is the goal of Olive Medical ...
Breaking Medicine Technology:The Worldwide Market for In Vitro Diagnostic Tests, 9th Edition 2The Worldwide Market for In Vitro Diagnostic Tests, 9th Edition 3MedExpress Quotes Late Summer, Early Fall As Best Time to Receive Flu Shot 2Olive Medical Achieves ISO 13485:2003 Certification 2
... Assured Pharmacy (Pink Sheets: APHY ), a ... sufferers of chronic pain announced that total sales on a ... $1,422,163 which equates to $67,722 per business day .  This ... of $1,402,374 for June 2010 and an increase of 6.2 ...
... Novavax, Inc. (Nasdaq: NVAX ) President and CEO ... Health and Human Services Secretary Kathleen Sebelius and other public ... development of drugs and vaccines to prevent the spread of ... the plan,s five key initiatives: Define and ...
Cached Medicine Technology:Assured Pharmacy Reports Same Store Sales for the Month of July 2010 2Assured Pharmacy Reports Same Store Sales for the Month of July 2010 3NOVAVAX Endorses New U.S. Initiatives to Develop Medical Countermeasures 2NOVAVAX Endorses New U.S. Initiatives to Develop Medical Countermeasures 3
... an ultra-capacity bacterial growth system, combines ... a high-capacity format for bacterial growth. ... with Bioneer's HT-Prep™ Automatic DNA Extractor. ... advantages over traditional floor shakers. Plate-holding ...
Inquire...
... Refrigerated incubators,Two refrigerated incubators ... life and life cycle,testing. Microprocessor ... digital temperature display. High/low audible ... contacts. Additional internal chamber safety ...
Inquire...
Medicine Products: