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:1/22/2015)... 22, 2015 Blue Cross and Blue Shield ... exemplify what it means to “Live Fearless.” , ... to share their stories about how they or someone they ... others by living in the moment. By telling these types ...
(Date:1/22/2015)... Thousand of GranuFlo lawsuits ( http://www.granuflolawsuit2014.com/ ... GranuFlo and NaturaLyte dialysis concentrates continue to move forward ... Court, District of Massachusetts, Bernstein Liebhard LLP reports. According ... remanded a case filed by the state of Louisiana ...
(Date:1/22/2015)... A study recently published in ... Medicine & Science in Sports & Exercise shows ... reduce gastrointestinal (GI) problems associated with physical strain ... the double-blind, placebo-controlled study took 10 grams of ...
(Date:1/22/2015)... Payday lending practices in four southern ... financial distress to the states that permit them, according ... Center on Race and Wealth. , While they generate ... loans at the same time substantially depress economic activity, ...
(Date:1/22/2015)... has released a new blog post explaining the importance of keeping ... costs of an auto insurance policy . , Clients who ... for their vehicle insurance policies. The safety a vehicle offers from ... Because of this, drivers should always carry a first aid kit ...
Breaking Medicine News(10 mins):Health News:Blue Cross and Blue Shield of Minnesota to Showcase “Faces of Fearless” 2Health News:Court Overseeing Federal GranuFlo Lawsuits Remands Louisiana Claim Back to State Court, Bernstein Liebhard LLP Reports 2Health News:Court Overseeing Federal GranuFlo Lawsuits Remands Louisiana Claim Back to State Court, Bernstein Liebhard LLP Reports 3Health News:Court Overseeing Federal GranuFlo Lawsuits Remands Louisiana Claim Back to State Court, Bernstein Liebhard LLP Reports 4Health News:Study Shows Kyowa Hakko’s L-Citrulline May Help Reduce Gastrointestinal Injury During Strenuous Exercise 2Health News:Study Shows Kyowa Hakko’s L-Citrulline May Help Reduce Gastrointestinal Injury During Strenuous Exercise 3Health News:Howard University Spotlights the Economic Impact of Payday Lending in Southern States 2Health News:Driving Safe And Other Factors That Make Auto Insurance Affordable! 2
... April 29 The very real possibility of a swine ... organizations that have not developed a plan to cope with ... Law & Business. To reduce the impact on operations, ... all organizations that haven,t done so to begin continuity planning ...
... after daily, Friday prayersWASHINGTON, April 29 A prominent ... on Islamic religious leaders, or imams, to use daily ... a platform for providing information about preventing the spread ... said imams are in a unique position to offer ...
... Onsite Pathogen DetectionST. GEORGE, Utah, April 29 DxNA announced ... flu and related world threat, it is developing a diagnostic ... H1N1 virus (known as swine flu) anywhere it is needed ... less than 10 pounds. The Company anticipates having a ...
... Sign Legislation to Provide Access to Medigap Secondary Insurance ... Fla., April 29 Following unanimous support in the ... voted unanimously for the bill renamed "The Alonzo Mourning ... population of Florida,s kidney failure patients and the disabled ...
... the nation,s leader in pain prescription monitoring, announced ... with Aetna to offer Aetna,s network of providers ... monitoring process. Ameritox,s patented Rx Guardian(SM) methodology is ... a patented methodology to help physicians assess whether ...
... of Care Support of AmericaNEW YORK, April 29 "Thirty ... their widowed or single Moms -- often from far away ... of Care Support of America ... dynamics. " This can be extraordinarily stressful for all ...
Cached Medicine News:Health News:If You Haven't Yet, Plan Now for a Pandemic, CCH Advises Employers 2Health News:If You Haven't Yet, Plan Now for a Pandemic, CCH Advises Employers 3Health News:If You Haven't Yet, Plan Now for a Pandemic, CCH Advises Employers 4Health News:CAIR Asks U.S. Muslim Prayer Leaders to Urge Swine Flu Precautions 2Health News:CAIR Asks U.S. Muslim Prayer Leaders to Urge Swine Flu Precautions 3Health News:DxNA to Use its Rapid Detection Platform to Simplify Testing for Swine Flu (H1N1 Virus) 2Health News:DxNA to Use its Rapid Detection Platform to Simplify Testing for Swine Flu (H1N1 Virus) 3Health News:Florida Legislature Unanimously Supports 'The Alonzo Mourning Access to Care Act' to Help State's Kidney Failure Patients and the Disabled 2Health News:Florida Legislature Unanimously Supports 'The Alonzo Mourning Access to Care Act' to Help State's Kidney Failure Patients and the Disabled 3Health News:Ameritox(R) Contracts With Aetna for Prescription Drug Monitoring Services 2Health News:10 Ways to Care for Mom on Mother's Day 2Health News:10 Ways to Care for Mom on Mother's Day 3Health News:10 Ways to Care for Mom on Mother's Day 4
(Date:1/23/2015)... lot of discussion in the medical community revolves around figuring ... conditions. As medical science advances, doctors and surgeons often feel ... consider to be more cutting edge. Yet, when it comes ... treatment that stands out as the best solution in all ...
(Date:1/23/2015)... 2015  MedScope ( www.medscope.org ), the leading provider of ... Connected World magazine Connected World Award for ... can be used anywhere, anytime. The nomination was made ... In nominating MedScope, Landon Garner , Director of ...
(Date:1/23/2015)... , Jan. 23, 2015  HyGreen, Inc., a leader ... and partnership with RCA Medical, a subsidiary of Ascendis ... . Each year, hundreds of millions of ... infections as organisms are transmitted from patient to patient ...
Breaking Medicine Technology:No One-Size-Fits-All Remedy for Hernia Correction 2MedScope Nominated by RacoWireless for Prestigious 2015 Connected World Magazine Connected World Award 2HyGreen Partners with RCA Medical in Johannesburg, South Africa 2
... liquid form has contributed to some dosage errors due to ... the Tamiflu pill form when developing their own liquid version ... Two pediatric patients in Pennsylvania hospitals received overdoses ... of unawareness among staff as to the concentration of the ...
... COPENHAGEN, November 2 Nuevolution ... derived from its collaboration with,Merck & Co. Inc., Whitehouse ... was triggered following identification of several candidate,molecules that conformed ... original agreement. These include several accepted drug-like,characteristics and nanomolar ...
Cached Medicine Technology:Alert: Two Overdoses of Tamiflu in Pediatric Patients in Pennsylvania 2Nuevolution Announces Receipt of Milestone Payment From Merck & Co., Inc. 2
Redesigning the World's Oxygen Therapy One Device at a Time. , ,Everything you like about our OXYMATIC 400 Series conservers, only better!...
... Oxygen Conservation Device. Bypass 6200: ... ,6200 Accessories: , OCD870C CGA ... 540 Regulator , OCD2001-18 Carrying ... , CP2140 Vertical M-6 Cylinder ...
... Medical announces its new CVD Diamond Knives. ... incredible sharpness of diamonds to be used ... blade sharpness improves stromal reapproximation, enhances healing, ... knives offer unlimited uses, and are available ...
The New Easy-To-Use Disposable Diamond Knife Cleaning System Can Remove Even Baked-On Debris In Seconds. It Is Much More Effective Than Steam Or Blocks Of Styrofoam, Much Safer For Employees As Wel...
Medicine Products: