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NVO

Novo Nordisk

$32.66

0.12 (0.37%)

13:04
11/29/16
11/29
13:04
11/29/16
13:04

Novo Nordisk says achieved primary endpoint in DEVOTE trial

Novo Nordisk announced the headline results from the DEVOTE trial, a long-term, randomized, double-blinded and event-driven trial conducted to confirm the cardiovascular safety of Tresiba compared to insulin glargine U100 when added to standard of care. In the trial, more than 7,500 people with type 2 diabetes at high risk of major adverse cardiovascular events were treated for a period of approximately two years.The trial achieved its primary endpoint by demonstrating non-inferiority of major adverse cardiovascular events with Tresiba compared to insulin glargine U100. The trial thereby confirmed the results of the DEVOTE interim analysis submitted to the U.S. FDA in March 2015, on the basis of which Tresiba and Ryzodeg 70/30 were approved in the U.S. in September 2015. The primary endpoint of the DEVOTE study was defined as the MACE composite outcome of the first occurrence of cardiovascular death, non-fatal myocardial infarction or non-fatal stroke and showed a hazard ratio of 0.91 in favour of Tresiba relative to insulin glargine U100, with no statistically significant difference between the two treatments. In the trial, Tresiba demonstrated superiority on the secondary confirmatory endpoint of severe hypoglycaemia: 27% fewer patients in the Tresiba treated group experienced an episode of severe hypoglycaemia, resulting in a 40% overall reduction of total episodes of adjudicated severe hypoglycaemia. Furthermore, patients in the Tresiba treated group experienced a 54% relative reduction in the rate of nocturnal severe hypoglycaemia. These differences were all statistically significant. Tresiba appeared to have a safe and well-tolerated profile consistent with previous clinical studies conducted with Tresiba.Novo Nordisk expects to present the detailed results of the DEVOTE trial at a scientific meeting and submit the findings for review with regulatory authorities during the first half of 2017.

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NVO Novo Nordisk
$32.66

0.12 (0.37%)

09/13/16
EXAN
09/13/16
UPGRADE
EXAN
Outperform
Novo Nordisk upgraded to Outperform from Neutral at Exane BNP Paribas
09/23/16
PIPR
09/23/16
INITIATION
PIPR
Neutral
Novo Nordisk initiated with a Neutral at Piper Jaffray
Piper Jaffray analyst Richard Purkiss started Novo Nordisk with a Neutral rating and DKK 320 price target.
10/28/16
BOFA
10/28/16
DOWNGRADE
BOFA
Underperform
Novo Nordisk downgraded to Underperform from Neutral at BofA/Merrill
10/31/16
SBSH
10/31/16
DOWNGRADE
SBSH
Neutral
Novo Nordisk downgraded to Neutral from Buy at Citi
Citi analyst Peter Verdult downgraded Novo Nordisk to Neutral citing the ongoing net pricing declines across the company's diabetes portfolio as well as expectations for margin erosion at Biopharmaceuticals due to NovoSeven/Norditropin pressures. The analyst cut his price target for the shares to DKK 260 from DKK 400.

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