Sulonex

Keryx Biopharmaceuticals Settles License Dispute With Alfa Wassermann

...ERX ) announced today that the Company and Alfa Wassermann S.p.A. have settled a dispute over issues arising from the terminated license agreement for sulonex (sulodexide). Under the terms of the settlement agreement, Alfa Wassermann is paying Keryx US$3,500,000 (of which US$2,750,000 has already been receiv...

Keryx Biopharmaceuticals, Inc. Announces First Quarter 2009 Financial Results

...income (loss) was primarily attributable to a $25,894,000 decrease in research and development expenses related to the cessation of the development of sulonex in March 2008, a $2,671,000 and $344,000 decrease in research and development expenses related to KRX-0401 and Zerenex, respectively, a $3,128,000 inc...

Keryx Biopharmaceuticals, Inc. Announces Third Quarter 2008 Financial Results

...e in net loss was primarily attributable to a $11,699,000 decrease in research and development expenses related to the cessation of the development of sulonex in March 2008, a $1,860,000 decrease in expenses related to our other clinical compounds, and a $519,000 decrease in non-cash compensation expense rel...

Keryx Biopharmaceuticals, Inc. Announces Second Quarter 2008 Financial Results

...e in net loss was primarily attributable to a $10,390,000 decrease in research and development expenses related to the cessation of the development of sulonex in March 2008, an $852,000 decrease in expenses related to our other clinical compounds, a $567,000 decrease in non-cash compensation expense related ...

Sulonex in Medical Technology

Keryx Biopharmaceuticals Announces Termination of SUN-MACRO Phase 4 Trial

...sed on a review of the available proteinuria data, sulonex did not appear to be different than placebo. The s...here can be no assurance that the results from the sulonex Phase 3 and/or Phase 4 study will track the data f...he DiNAS Phase 2 study. Results from these earlier sulonex studies may not be indicative of results from futu...

Keryx Biopharmaceuticals Announces that the SUN-MICRO Phase 3 Clinical Trial Failed to Meet its Primary Efficacy Endpoint

...sults from its SUN-MICRO Phase 3 clinical trial of sulonex (sulodexide) for the treatment of diabetic nephrop...here can be no assurance that the results from the sulonex Phase 3 study will track the data from the pilot C...he DiNAS Phase 2 study. Results from these earlier sulonex studies may not be indicative of results from futu...

Keryx Biopharmaceuticals Completes SUN-MICRO Phase 3 Pivotal Trial

...A filing before year end. "The completion of the sulonex Phase 3 clinical program is an important and signi...d analyzing the data from this study." ABOUT THE sulonex (sulodexide oral gelcap) PHASE 3 and PHASE 4 CLINI...e of the filing of the NDA for sulodexide. ABOUT sulonex (sulodexide oral gelcap) Sulodexide belongs to a...

Sulodexide Data Safety Monitoring Committee Completes Additional Review of Phase 3 Study Data

...rial. The DSMC raised no safety concerns regarding sulonex or the trial. As planned, no review was conducted ...SULONEX(TM) PHASE 3 and PHASE 4 CLINICAL PROGRAM sulonex is in a pivotal Phase 3 and Phase 4 clinical progr...ling of the NDA for Sulonex. ABOUT SULONEX(TM) sulonex (sulodexide oral gelcap) belongs to a proposed new...

Keryx Biopharmaceuticals, Inc. Announces Poster Presentations Highlighting Mechanism of Action and Clinical Activity of Sulonex(TM) (sulodexide oral gelcap) at the Upcoming American Diabetes Association 67th Scientific Sessions in Chicago, Illinois

...rael, New York, NY ABOUT SULONEX(TM) sulonex (sulodexide oral gelcap) belongs to a proposed new...es in which the kidneys are progressively damaged. sulonex is a glycosaminoglycan compound with structural si...n excretion in patients with diabetic nephropathy. sulonex is in a pivotal Phase III and Phase IV clinical pr...

Keryx Biopharmaceuticals, Inc. Announces Positive Phase I and Phase II Data on KRX-0401 in Patients with Relapsed/Refractory Multiple Myeloma and Waldenstrom's Macroglobulinemia

...s KRX-101, a first-in-class, oral heparinoid compound for the treatment of diabetic nephropathy, a life-threatening kidney disease caused by diabetes. sulonex is in a pivotal Phase III and Phase IV clinical program under a Special Protocol Assessment with the Food & Drug Administration. Additionally, Ker...

Sulonex in Biological Technology

Keryx Biopharmaceuticals, Inc. Announces Second Quarter 2009 Financial Results

...cash from a settlement with the former licensor of sulonex (sulodexide). The Company will receive an additio...ses related to the cessation of the development of sulonex in March 2008. The net income for the six m...ses related to the cessation of the development of sulonex in March 2008, a $4.4 million decrease in research...

Keryx Biopharmaceuticals, Inc. Announces Fourth Quarter and Year-End 2008 Financial Results

...rch and development expenses related to the cessation of the development of sulonex in March 2008, a $7,013,000 and $2,735,000 decrease in research and develop...rch and development expenses related to the cessation of the development of sulonex in March 2008, a $8,165,000 and $1,401,000 decrease in research and develop...

Keryx Biopharmaceuticals, Inc. Announces First Quarter 2008 Financial Results

... cessation of our development of Sulonex. Such costs included an $11,037,000 non-cash impairment charge related to the write-down of the assets of the sulonex manufacturing suite to their estimated fair value, and a $2,063,000 provision for estimated costs relating to the required restoration of the manufact...

Keryx Biopharmaceuticals Announces Implementation of Strategic Restructuring Plan

...17 million, and is primarily related to the completion and shut-down of the sulonex clinical program and restructuring costs. Additional elements of the Comp... severance benefits and a non-cash write-off of the assets of the Company's sulonex manufacturing facility. As part of the workforce reduction, the position ...

Keryx Biopharmaceuticals Announces that SUN-MICRO Phase 3 Clinical Trial Fails to Meet Primary Efficacy Endpoint

...sults from its SUN-MICRO Phase 3 clinical trial of sulonex (sulodexide) for the treatment of diabetic nephrop...here can be no assurance that the results from the sulonex Phase 3 study will track the data from the pilot C...he DiNAS Phase 2 study. Results from these earlier sulonex studies may not be indicative of results from futu...

Keryx Biopharmaceuticals, Inc. Announces Fourth Quarter and Year-End 2007 Financial Results

... and development expenses related to the Company's sulonex pivotal Phase 3 and Phase 4 clinical program, a $6...iew of the safety and efficacy data related to the sulonex Phase 3 trial, at which time the DSMC again found ...r ability to finalize the new drug application for sulonex before year-end, even if we receive positive resul...

Keryx Biopharmaceuticals Announces Additions to Management Team

...o build the corporate infrastructure to manage both the potential launch of sulonex and the future development and commercialization of our other drug candidat...o differ materially are the following: the results of the Phase 3 study for sulonex could be inconclusive or negative; even if we receive positive results from...

Keryx Biopharmaceuticals, Inc. Announces Third Quarter 2007 Financial Results

...,000 increase in research and development expenses related to the Company's sulonex pivotal Phase III and Phase IV clinical program, a $3,834,000 increase in e...lue of our product portfolio. We continue to stay focused on completing the sulonex clinical development program, with data from our Phase III study expected i...