Veloxis Pharmaceutic (LFCYF) 0.2000 $LFCYF
Veloxis Announces Change In Management
PR Newswire - Thu Dec 10, 3:32PM CST
Veloxis Pharmaceuticals A/S (NASDAQ: VELO) announced today that Dr. William J. Polvino steps down as President and CEO after more than six years in the role.
Veloxis Establishes Sponsored Level 1 ADR Program in U.S.
PR Newswire - Wed Oct 14, 2:00AM CDT
Veloxis Pharmaceuticals A/S (OMX: VELO) today announces the establishment of a sponsored Level 1 American depositary receipt (ADR) program in the U.S. The ADR trades under the symbol VXPZY.
Veloxis Announces Publication of Phase III-b STRATO Study of Envarsus® XR Demonstrating Reduction in Hand Tremors Compared to Twice-Daily Tacrolimus in Kidney Transplant Patients
PR Newswire - Mon Sep 21, 7:15AM CDT
Veloxis Pharmaceuticals A/S (OMX: VELO) is announcing the publication of the Phase IIIb Switching STudy of Kidney TRansplant PAtients to LCP-TacrO (STRATO) in the journal Clinical Transplantation. The STRATO study was an open-label, multicenter study demonstrating that kidney transplant patients treated with once-daily Envarsus® XR (formerly known as LCP-Tacro) experienced a reduction in hand tremors following conversion from twice-daily tacrolimus, while maintaining comparable tacrolimus exposure. The results of this study have been presented previously at the 13th American Transplant Congress.
Envarsus® XR Data to be Presented at European Society of Transplantation
PR Newswire - Thu Sep 10, 7:15AM CDT
Veloxis Pharmaceuticals A/S (OMX: VELO) announced that the full data set of the ASTCOFF (A STeady-state Pharmacokinetic COmparison Of all Tacrolimus Formulations) study, demonstrating the differentiated pharmacokinetic (PK) profile of Envarsus XR compared to Twice-Daily Prograf® and Once-Daily Astagraf® will be presented at the European Society of Transplantation Conference (ESOT) in Brussels. The presentation is entitled "A steady-state pharmacokinetic comparison of all FK-506 formulations (ASTCOFF study): an open label, prospective, randomized, two arm, three period crossover study", Abst. BO416, 8:00 AM, and will be presented Wednesday, September 16th, 2015/Studio 206. The presentation is available at http://www.veloxis.com/envarsus.cfm. There are several additional presentations on Envarsus® XR at ATC, which are listed below.
Veloxis Pharmaceuticals Envarsus® XR Granted Orphan Drug Status by U.S. Food and Drug Administration for Kidney Transplant Rejection Prophylaxis
PR Newswire - Fri Aug 14, 3:56PM CDT
Veloxis Pharmaceuticals A/S (OMX: VELO), today announced that Envarsus® XR was granted Orphan Drug status by the U.S. Food and Drug Administration (FDA) for prophylaxis of organ rejection in patients who convert from immediate-release tacrolimus. Envarsus® XR received marketing authorization from the FDA on July 10, 2015.
Autoimmune Hepatitis - Global Clinical Trials Review, H1, 2015
M2 - Mon Jul 27, 7:46AM CDT
Research and Markets (http://www.researchandmarkets.com/research/4j64cz/autoimmune) has announced the addition of the "Autoimmune Hepatitis Global Clinical Trials Review, H1, 2015" report to their offering. "Autoimmune Hepatitis Global Clinical Trials Review, H1, 2015" provides data on the Autoimmune Hepatitis clinical trial scenario. This report provides elemental information and data relating to the clinical trials on Autoimmune Hepatitis. It includes an overview of the trial numbers and their recruitment status as per the site of trial conduction across the globe. The databook offers a preliminary coverage of disease clinical trials by their phase, trial status, prominence of the sponsors and also provides briefing pertaining to the number of trials for the key drugs for treating Autoimmune Hepatitis. Scope - Data on the number of clinical trials conducted in North America, South and Central America, Europe, Middle-East and Africa and Asia-pacific and top five national contributions in each - Clinical trial (complete and in progress) data by phase, trial status, subjects recruited and sponsor type - Listings of discontinued trials (suspended, withdrawn and terminated) Top Companies/Institution Participating in Autoimmune Hepatitis Therapeutics Clinical Trials - Veloxis Pharmaceuticals A/S - Iltoo Pharma - Dr. Falk Pharma GmbH - BioIncept, LLC - Alfact Innovation - Beijing 302 Hospital - Juntendo University School of Medicine - Mayo Clinic - Rigshospitalet - Tehran University of Medical Sciences - The National Institute of Allergy and Infectious Diseases - University of Sao Paulo General Hospital For more information visit http://www.researchandmarkets.com/research/4j64cz/autoimmune
Veloxis Announces U.S. FDA Approval of Envarsus® XR for Treatment of Kidney Transplant Patients
PR Newswire - Fri Jul 10, 2:38PM CDT
Veloxis Pharmaceuticals A/S (OMX: VELO) today announced U.S. Food and Drug Administration (FDA) approval of Envarsus® XR (tacrolimus extended-release tablets) for the prophylaxis of rejection in kidney transplant patients who require or desire conversion from other twice-daily tacrolimus products to once-daily Envarsus® XR. Veloxis expects Envarsus® XR to be available to patients in the United States and their physicians in 4Q2015.
Envarsus® XR Demonstrates Differentiated Pharmacokinetic Profile Compared to Twice-Daily Prograf® or Once-Daily Astagraf XL® in Stable Kidney Transplant Patients
PR Newswire - Wed Jun 24, 10:30AM CDT
Veloxis Pharmaceuticals A/S (OMX: VELO) today announced top-line results of the ASTCOFF study, A STeady-state Pharmacokinetic COmparison Of all FK-506 Formulations, demonstrating that once-daily Envarsus® XR (tacrolimus extended-release tablets), an investigational new drug under FDA review for the prevention of organ rejection in adult kidney transplant patients, achieved differentiated pharmacokinetics (PK) when compared to twice-daily tacrolimus (Prograf®) or a once-daily tacrolimus product (Astagraf XL®).
U.S. District Court Rules in Veloxis Litigation
PR Newswire - Fri Jun 12, 1:06PM CDT
Veloxis Pharmaceuticals A/S (OMX: VELO) today announced that the U.S. District Court for the District of Columbia ruled in favor of the U.S. Food and Drug Administration (FDA) in the lawsuit filed by Veloxis against FDA. The Court's ruling leaves intact FDA's October 30, 2014 tentative approval of Envarsus XR (tacrolimus extended-release tablets), which delays full approval for use in newly transplanted kidney transplant recipients ("de novo" patients). Veloxis has today submitted revised labeling to FDA with the goal of making Envarsus XR available as soon as possible for kidney transplant patients who wish to convert from twice-daily tacrolimus products to once-daily Envarsus XR. Veloxis expects its amendment to the labeling to be a Class 1 labelling change to the Envarsus XR NDA and subject to a 2-month PDUFA target timeline for FDA review. With an expected 2-month labeling review timeline, Veloxis plans to launch in the conversion segment in 4Q2015 following successful labeling review and approval by the FDA. PDUFA timelines are internal targets for the FDA and are not binding commitments. The actual review timeline may be shorter or longer than the target. Approval in the de novo setting will be delayed until expiration of the exclusivity period for Astellas' Astagraf XL® which will occur in July 2016, or Jan 2017 if pediatric exclusivity extension is awarded to Astellas.
Envarsus® XR Demonstrates Improved Pharmacokinetic Profile in African-American Transplant Recipients
PR Newswire - Mon May 04, 6:00AM CDT
Veloxis Pharmaceuticals A/S (OMX: VELO) today announced that once-daily Envarsus® XR (tacrolimus extended-release tablets), an investigational new drug under FDA review for the prevention of organ rejection in adult kidney transplant patients, demonstrated that a lower dose of once-daily Envarsus XR in African-American kidney transplant patients is sufficient to achieve therapeutic tacrolimus blood concentrations, compared to twice-daily immediate release tacrolimus. These data, which are from one of the largest trials of tacrolimus pharmacokinetics (PK) in African-American kidney transplant patients conducted to date, were presented at the American Transplant Congress (ATC) on May 3, 2015, in Philadelphia, in a presentation entitled "PK and Pharmacogenomics of Once-daily MeltDose® Tacrolimus (Envarsus® XR) vs. Twice-daily Tacrolimus: A Randomized Cross-over Study in Stable African-American Kidney Transplant Patients (ASERTAA)". There are several additional presentations on Envarsus XR at ATC, which are listed below.
U.S. District Court Sets Briefing Schedule in Veloxis Litigation
PR Newswire - Wed Jan 14, 1:32PM CST
Veloxis Pharmaceuticals A/S (OMX: VELO) (Veloxis) today confirmed that the U.S. District Court for the District of Columbia has set a briefing schedule that enables complete briefing in its pending case by March 3, 2015. Veloxis is seeking an order requiring FDA to grant final approval to Envarsus® XR. While Veloxis currently expects the matter to be resolved by mid-year 2015, it is possible that delays may occur. There can be no assurance that Veloxis will be successful in its action against FDA.
Veloxis Confirms Receipt of U.S. Food and Drug Administration Decision
PR Newswire - Tue Jan 13, 2:05AM CST
Veloxis Pharmaceuticals A/S (OMX: VELO) (Veloxis) today confirmed that it has received notice from the U.S. Food and Drug Administration (FDA) stating that FDA continues to take the position that the exclusivity for Astagraf XL should require delay in the formal approval of Envarsus® XR. FDA has stated that it would be prepared to approve Envarsus XR for use only in patients converted from an immediate release formulation of tacrolimus to Envarsus XR, subject to Veloxis not seeking approval for de novo use of Envarsus until on or after July 19, 2016. Veloxis continues to disagree with FDA's unprecedented position on this matter, and looks forward to presenting the merits of its case in support of final approval of Envarsus XR.
Veloxis Comments on U.S. District Court Order
PR Newswire - Fri Dec 19, 8:41AM CST
Veloxis Pharmaceuticals A/S (OMX: VELO) (Veloxis) today issued the following statement regarding an order issued by the U.S. District Court for the District of Columbia in connection with the action Veloxis filed on December 16, 2014 against the Food and Drug Administration (FDA), seeking an order requiring the FDA to grant final approval to Envarsus® XR:
Veloxis Announces Publication of Phase III Study of Once Daily Envarsus® XR Demonstrating Non-Inferiority vs. Twice-Daily Tacrolimus in De Novo Kidney Transplant Patients
PR Newswire - Mon Nov 17, 7:53AM CST
Veloxis Pharmaceuticals A/S (OMX: VELO) today announced the publication of the Phase III study (Study 3002) of once-daily Envarsus® XR demonstrating non-inferiority vs. twice-daily tacrolimus (Prograf®) in de novo kidney transplant patients in the American Journal of Transplantation.
Veloxis announces tentative approval of Envarsus® XR
PR Newswire - Fri Oct 31, 6:16AM CDT
Veloxis Pharmaceuticals A/S (OMX: VELO) announced today that the U.S. Food and Drug Administration has informed Veloxis of the tentative approval of Envarsus® XR. FDA stated that the final approval of Envarsus XR will be delayed until expiration of the exclusivity period for Astellas' Astagraf XL®. Veloxis understands that this expiry is anticipated to occur July 19, 2016. FDA's approval notice stated that it is "subject to change on the basis of any new information that may come to FDA's attention."
Veloxis Announces Change In Management
PR Newswire - Thu Dec 10, 3:32PM CST
Veloxis Pharmaceuticals A/S (NASDAQ: VELO) announced today that Dr. William J. Polvino steps down as President and CEO after more than six years in the role.
Veloxis Establishes Sponsored Level 1 ADR Program in U.S.
PR Newswire - Wed Oct 14, 2:00AM CDT
Veloxis Pharmaceuticals A/S (OMX: VELO) today announces the establishment of a sponsored Level 1 American depositary receipt (ADR) program in the U.S. The ADR trades under the symbol VXPZY.
Veloxis Announces Publication of Phase III-b STRATO Study of Envarsus® XR Demonstrating Reduction in Hand Tremors Compared to Twice-Daily Tacrolimus in Kidney Transplant Patients
PR Newswire - Mon Sep 21, 7:15AM CDT
Veloxis Pharmaceuticals A/S (OMX: VELO) is announcing the publication of the Phase IIIb Switching STudy of Kidney TRansplant PAtients to LCP-TacrO (STRATO) in the journal Clinical Transplantation. The STRATO study was an open-label, multicenter study demonstrating that kidney transplant patients treated with once-daily Envarsus® XR (formerly known as LCP-Tacro) experienced a reduction in hand tremors following conversion from twice-daily tacrolimus, while maintaining comparable tacrolimus exposure. The results of this study have been presented previously at the 13th American Transplant Congress.
Envarsus® XR Data to be Presented at European Society of Transplantation
PR Newswire - Thu Sep 10, 7:15AM CDT
Veloxis Pharmaceuticals A/S (OMX: VELO) announced that the full data set of the ASTCOFF (A STeady-state Pharmacokinetic COmparison Of all Tacrolimus Formulations) study, demonstrating the differentiated pharmacokinetic (PK) profile of Envarsus XR compared to Twice-Daily Prograf® and Once-Daily Astagraf® will be presented at the European Society of Transplantation Conference (ESOT) in Brussels. The presentation is entitled "A steady-state pharmacokinetic comparison of all FK-506 formulations (ASTCOFF study): an open label, prospective, randomized, two arm, three period crossover study", Abst. BO416, 8:00 AM, and will be presented Wednesday, September 16th, 2015/Studio 206. The presentation is available at http://www.veloxis.com/envarsus.cfm. There are several additional presentations on Envarsus® XR at ATC, which are listed below.
Veloxis Pharmaceuticals Envarsus® XR Granted Orphan Drug Status by U.S. Food and Drug Administration for Kidney Transplant Rejection Prophylaxis
PR Newswire - Fri Aug 14, 3:56PM CDT
Veloxis Pharmaceuticals A/S (OMX: VELO), today announced that Envarsus® XR was granted Orphan Drug status by the U.S. Food and Drug Administration (FDA) for prophylaxis of organ rejection in patients who convert from immediate-release tacrolimus. Envarsus® XR received marketing authorization from the FDA on July 10, 2015.
Autoimmune Hepatitis - Global Clinical Trials Review, H1, 2015
M2 - Mon Jul 27, 7:46AM CDT
Research and Markets (http://www.researchandmarkets.com/research/4j64cz/autoimmune) has announced the addition of the "Autoimmune Hepatitis Global Clinical Trials Review, H1, 2015" report to their offering. "Autoimmune Hepatitis Global Clinical Trials Review, H1, 2015" provides data on the Autoimmune Hepatitis clinical trial scenario. This report provides elemental information and data relating to the clinical trials on Autoimmune Hepatitis. It includes an overview of the trial numbers and their recruitment status as per the site of trial conduction across the globe. The databook offers a preliminary coverage of disease clinical trials by their phase, trial status, prominence of the sponsors and also provides briefing pertaining to the number of trials for the key drugs for treating Autoimmune Hepatitis. Scope - Data on the number of clinical trials conducted in North America, South and Central America, Europe, Middle-East and Africa and Asia-pacific and top five national contributions in each - Clinical trial (complete and in progress) data by phase, trial status, subjects recruited and sponsor type - Listings of discontinued trials (suspended, withdrawn and terminated) Top Companies/Institution Participating in Autoimmune Hepatitis Therapeutics Clinical Trials - Veloxis Pharmaceuticals A/S - Iltoo Pharma - Dr. Falk Pharma GmbH - BioIncept, LLC - Alfact Innovation - Beijing 302 Hospital - Juntendo University School of Medicine - Mayo Clinic - Rigshospitalet - Tehran University of Medical Sciences - The National Institute of Allergy and Infectious Diseases - University of Sao Paulo General Hospital For more information visit http://www.researchandmarkets.com/research/4j64cz/autoimmune
Veloxis Announces U.S. FDA Approval of Envarsus® XR for Treatment of Kidney Transplant Patients
PR Newswire - Fri Jul 10, 2:38PM CDT
Veloxis Pharmaceuticals A/S (OMX: VELO) today announced U.S. Food and Drug Administration (FDA) approval of Envarsus® XR (tacrolimus extended-release tablets) for the prophylaxis of rejection in kidney transplant patients who require or desire conversion from other twice-daily tacrolimus products to once-daily Envarsus® XR. Veloxis expects Envarsus® XR to be available to patients in the United States and their physicians in 4Q2015.
Envarsus® XR Demonstrates Differentiated Pharmacokinetic Profile Compared to Twice-Daily Prograf® or Once-Daily Astagraf XL® in Stable Kidney Transplant Patients
PR Newswire - Wed Jun 24, 10:30AM CDT
Veloxis Pharmaceuticals A/S (OMX: VELO) today announced top-line results of the ASTCOFF study, A STeady-state Pharmacokinetic COmparison Of all FK-506 Formulations, demonstrating that once-daily Envarsus® XR (tacrolimus extended-release tablets), an investigational new drug under FDA review for the prevention of organ rejection in adult kidney transplant patients, achieved differentiated pharmacokinetics (PK) when compared to twice-daily tacrolimus (Prograf®) or a once-daily tacrolimus product (Astagraf XL®).
U.S. District Court Rules in Veloxis Litigation
PR Newswire - Fri Jun 12, 1:06PM CDT
Veloxis Pharmaceuticals A/S (OMX: VELO) today announced that the U.S. District Court for the District of Columbia ruled in favor of the U.S. Food and Drug Administration (FDA) in the lawsuit filed by Veloxis against FDA. The Court's ruling leaves intact FDA's October 30, 2014 tentative approval of Envarsus XR (tacrolimus extended-release tablets), which delays full approval for use in newly transplanted kidney transplant recipients ("de novo" patients). Veloxis has today submitted revised labeling to FDA with the goal of making Envarsus XR available as soon as possible for kidney transplant patients who wish to convert from twice-daily tacrolimus products to once-daily Envarsus XR. Veloxis expects its amendment to the labeling to be a Class 1 labelling change to the Envarsus XR NDA and subject to a 2-month PDUFA target timeline for FDA review. With an expected 2-month labeling review timeline, Veloxis plans to launch in the conversion segment in 4Q2015 following successful labeling review and approval by the FDA. PDUFA timelines are internal targets for the FDA and are not binding commitments. The actual review timeline may be shorter or longer than the target. Approval in the de novo setting will be delayed until expiration of the exclusivity period for Astellas' Astagraf XL® which will occur in July 2016, or Jan 2017 if pediatric exclusivity extension is awarded to Astellas.
Envarsus® XR Demonstrates Improved Pharmacokinetic Profile in African-American Transplant Recipients
PR Newswire - Mon May 04, 6:00AM CDT
Veloxis Pharmaceuticals A/S (OMX: VELO) today announced that once-daily Envarsus® XR (tacrolimus extended-release tablets), an investigational new drug under FDA review for the prevention of organ rejection in adult kidney transplant patients, demonstrated that a lower dose of once-daily Envarsus XR in African-American kidney transplant patients is sufficient to achieve therapeutic tacrolimus blood concentrations, compared to twice-daily immediate release tacrolimus. These data, which are from one of the largest trials of tacrolimus pharmacokinetics (PK) in African-American kidney transplant patients conducted to date, were presented at the American Transplant Congress (ATC) on May 3, 2015, in Philadelphia, in a presentation entitled "PK and Pharmacogenomics of Once-daily MeltDose® Tacrolimus (Envarsus® XR) vs. Twice-daily Tacrolimus: A Randomized Cross-over Study in Stable African-American Kidney Transplant Patients (ASERTAA)". There are several additional presentations on Envarsus XR at ATC, which are listed below.
U.S. District Court Sets Briefing Schedule in Veloxis Litigation
PR Newswire - Wed Jan 14, 1:32PM CST
Veloxis Pharmaceuticals A/S (OMX: VELO) (Veloxis) today confirmed that the U.S. District Court for the District of Columbia has set a briefing schedule that enables complete briefing in its pending case by March 3, 2015. Veloxis is seeking an order requiring FDA to grant final approval to Envarsus® XR. While Veloxis currently expects the matter to be resolved by mid-year 2015, it is possible that delays may occur. There can be no assurance that Veloxis will be successful in its action against FDA.
Veloxis Confirms Receipt of U.S. Food and Drug Administration Decision
PR Newswire - Tue Jan 13, 2:05AM CST
Veloxis Pharmaceuticals A/S (OMX: VELO) (Veloxis) today confirmed that it has received notice from the U.S. Food and Drug Administration (FDA) stating that FDA continues to take the position that the exclusivity for Astagraf XL should require delay in the formal approval of Envarsus® XR. FDA has stated that it would be prepared to approve Envarsus XR for use only in patients converted from an immediate release formulation of tacrolimus to Envarsus XR, subject to Veloxis not seeking approval for de novo use of Envarsus until on or after July 19, 2016. Veloxis continues to disagree with FDA's unprecedented position on this matter, and looks forward to presenting the merits of its case in support of final approval of Envarsus XR.
Veloxis Comments on U.S. District Court Order
PR Newswire - Fri Dec 19, 8:41AM CST
Veloxis Pharmaceuticals A/S (OMX: VELO) (Veloxis) today issued the following statement regarding an order issued by the U.S. District Court for the District of Columbia in connection with the action Veloxis filed on December 16, 2014 against the Food and Drug Administration (FDA), seeking an order requiring the FDA to grant final approval to Envarsus® XR:
Veloxis Announces Publication of Phase III Study of Once Daily Envarsus® XR Demonstrating Non-Inferiority vs. Twice-Daily Tacrolimus in De Novo Kidney Transplant Patients
PR Newswire - Mon Nov 17, 7:53AM CST
Veloxis Pharmaceuticals A/S (OMX: VELO) today announced the publication of the Phase III study (Study 3002) of once-daily Envarsus® XR demonstrating non-inferiority vs. twice-daily tacrolimus (Prograf®) in de novo kidney transplant patients in the American Journal of Transplantation.
Veloxis announces tentative approval of Envarsus® XR
PR Newswire - Fri Oct 31, 6:16AM CDT
Veloxis Pharmaceuticals A/S (OMX: VELO) announced today that the U.S. Food and Drug Administration has informed Veloxis of the tentative approval of Envarsus® XR. FDA stated that the final approval of Envarsus XR will be delayed until expiration of the exclusivity period for Astellas' Astagraf XL®. Veloxis understands that this expiry is anticipated to occur July 19, 2016. FDA's approval notice stated that it is "subject to change on the basis of any new information that may come to FDA's attention."
