H Lundbeck A/S (HLUKF.PK) News| Reuters.com
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H Lundbeck A/S (HLUKF.PK)

HLUKF.PK on OTC Markets Group

14 Jun 2016
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Thu, Jun 23 2016

BRIEF-Lundbeck says U.S. FDA approves changes to Sabril REMS program

* Lundbeck says u.s. Fda approves changes to sabril rems program

BRIEF-Lundbeck enters main Copenhagen stock index, Tryg leaves

* Says H. Lundbeck will be added to the OMX Copenhagen 20 CAP index

BRIEF-Lundbeck: Trintellix (vortioxetine) now available in US

* Says trade name for the vortioxetine product in US would be changed to Trintellix to avoid name confusion

Lundbeck on road to recovery as drugmaker returns to profit

COPENHAGEN, May 11 Danish pharmaceutical company Lundbeck showed signs that its turnaround plan under its new chief executive was bearing fruit after reporting a sharp swing into profit in the first quarter.

BRIEF-H Lundbeck Q1 EBIT 483 million; beats expectations

* Q1 revenue 3.77 billion Danish crowns ($576.96 million) (Reuters poll 3.62 billion crowns)

BRIEF-Lundbeck and Takeda receive complete response letter by FDA for Brintellix (vortioxetine) sNDA

* Says Lundbeck and Takeda receive complete response letter (CRL) by the U.S. Food and Drug Administration (FDA) for Brintellix (vortioxetine) supplemental new drug application (sNDA)

BRIEF-Lundbeck starts clinical phase III program with Lu AF35700

* Says starts clinical phase III program with Lu AF35700 in patients with treatment resistant schizophrenia

BRIEF-Lundbeck Q4 EBIT loss DKK 432 million, below expectations

* In 2015, revenue reached 14.59 billion Danish crowns representing an increase of 8 pct (0 pct in local currencies)

CORRECTED-NORDIC STOCKS - Factors to watch on Feb 4

(Corrects to make clear Lundbeck's drug Brintellix is already approved in the United States) The following stocks may be affected by newspaper reports and other factors on Thursday:

Lundbeck wins U.S. backing that may extend use of anti-depressant

COPENHAGEN Denmark's Lundbeck said on Thursday a U.S. Food and Drug Administration (FDA) committee had recommended that its anti-depression drug Brintellix can add improved cognitive functions to its information leaflet, a first of its kind.

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