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Last kr1.08 DKK
Change Today 0.00 / 0.00%
Volume 259.0K
VELO On Other Exchanges
Symbol
Exchange
Copenhagen
OTC US
Frankfurt
OTC US
As of 11:04 AM 08/4/15 All times are local (Market data is delayed by at least 15 minutes).

veloxis pharmaceuticals a/s (VELO) Snapshot

Open
kr1.05
Previous Close
kr1.08
Day High
kr1.09
Day Low
kr1.05
52 Week High
09/30/14 - kr2.10
52 Week Low
04/30/15 - kr0.75
Market Cap
1.8B
Average Volume 10 Days
780.4K
EPS TTM
kr-0.03
Shares Outstanding
1.7B
EX-Date
--
P/E TM
--
Dividend
--
Dividend Yield
--
Current Stock Chart for VELOXIS PHARMACEUTICALS A/S (VELO)

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veloxis pharmaceuticals a/s (VELO) Details

Veloxis Pharmaceuticals A/S operates as a specialty pharmaceutical company. The company’s proprietary technology, MeltDose is designed to enhance the absorption and bioavailability of select orally administered drugs. Its lead product candidate is Envarsus, a once-daily dosage tablet version of tacrolimus for the treatment of kidney transplant patients. The company was formerly known as LifeCycle Pharma A/S and changed its name to Veloxis Pharmaceuticals A/S in July 2011. Veloxis Pharmaceuticals A/S is headquartered in Hørsholm, Denmark.

30 Employees
Last Reported Date: 05/20/15

veloxis pharmaceuticals a/s (VELO) Top Compensated Officers

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Executives, Board Directors

veloxis pharmaceuticals a/s (VELO) Key Developments

Veloxis Pharmaceuticals A/S Announces U.S. FDA Approval of Envarsus XR for Treatment of Kidney Transplant Patients

Veloxis Pharmaceuticals A/S 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 fourth quarter of 2015. Envarsus® XR is an extended release formulation of tacrolimus designed for once-daily dosing, with flatter pharmacokinetics and greater bioavailability compared to twice-daily tacrolimus. The FDA marketing approval is based on the review of two Phase III trials and several Phase II trials in kidney transplant recipients. In all of the clinical trials, Envarsus® XR dosed once daily demonstrated significantly higher bioavailability and a flatter PK profile, compared to the current transplant drug, Prograf® (immediate release tacrolimus), dosed twice-daily.

Veloxis Pharmaceuticals Announces Results from Kidney Transplant Study

Veloxis Pharmaceuticals A/S has announced results from the ASTCOFF study, A STeady-state Pharmacokinetic COmparison Of all FK-506 Formulations, demonstrating that once-daily Envarsus XR, an investigational new drug for the prevention of organ rejection in adult kidney transplant patients, achieved differentiated pharmacokinetics, or PK, when compared to twice-daily tacrolimus, or Prograf, or a once-daily tacrolimus product, or Astagraf XL. ASTCOFF is the first pharmacokinetic study to compare all three of these branded formulations of tacrolimus and is a two-sequence, three-period crossover study, designed to compare the steady-state PK profiles of Envarsus XR tablets (Veloxis Pharmaceuticals Inc.), Astagraf XL (Astellas Pharma US Inc.) capsules administered once-daily and Prograf capsules (Astellas Pharma US Inc.) administered twice-daily in stable renal transplant patients. Patients were dosed with each drug for seven days and blood samples were obtained over 24 hours to obtain pharmacokinetic data.

Veloxis Pharmaceuticals A/S Announces Top-Line Results of the ASTCOFF Study

Veloxis Pharmaceuticals A/S announced top-line results of the ASTCOFF study, ASTeady-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 capsules administered once-daily and Prograf capsules administered twice-daily in stable renal transplant patients. Patients were dosed with each drug for seven days and blood samples were obtained over 24 hours to obtain pharmacokinetic data. This study confirmed previously published data for Envarsus and showed greater bioavailability (p<0.0001) and a flatter PK profile characterized by lower peak-to-trough fluctuation (p<0.001) and delayed time to peak concentrations of 6 hrs (p=<0.001) compared to both Prograf and Astagraf. At equivalent exposure, Envarsus achieves at least a 30% dose reduction requirement and a substantively lower peak blood concentration (p=<0.005) compared to the two comparator products.

 

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VELO

Industry Average

Valuation VELO Industry Range
Price/Earnings NM Not Meaningful
Price/Sales 15.9x
Price/Book 8.0x
Price/Cash Flow NM Not Meaningful
TEV/Sales 13.9x
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