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Clinuvel Pharmaceuticals Ltd (CLVLY.PK)

CLVLY.PK on OTC Markets Group

6.95USD
22 Nov 2017
Change (% chg)

$0.14 (+2.06%)
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$6.81
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Volume
3,500
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6,907
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$7.00
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Latest Key Developments (Source: Significant Developments)

Clinuvel Pharmaceuticals provides update on Scenesse FDA filing
Monday, 18 Sep 2017 07:24pm EDT 

Sept 19 (Reuters) - Clinuvel Pharmaceuticals Ltd :Clinuvel provides update on Scenesse FDA filing.Clinuvel pharmaceuticals says ‍European post-marketing safety data to be submitted as part of new drug application, expected in december 2017​.Seeking approval from FDA to market Scenesse in us.Has agreed with fda that safety data generated under european pass will form part of nda submission.Safety profile of Scenesse has been positive to date and no safety concerns have been detected from European distribution thus far.Obtained a positive FDA answer on acceptance of current safety data, as FDA issued a carcinogenicity waiver in 2017.First full statistical analyses of european post authorisation data are due to be available in December 2017.  Full Article

Clinuvel Pharmaceuticals says FY net profit for the period attributable $7.1 mln
Wednesday, 30 Aug 2017 03:25am EDT 

Aug 30 (Reuters) - Clinuvel Pharmaceuticals Ltd ::FY revenues from ordinary activities increased 165 percent to $17.0 million.FY net profit for the period attributable to members $7.1 million, up 326 percent.  Full Article

Clinuvel Pharmaceuticals says NICE England Updates on SCENESSE
Monday, 1 May 2017 09:49pm EDT 

May 2 (Reuters) - Clinuvel Pharmaceuticals Ltd :Department of health designated scenesse to be evaluated as a highly specialised technology.  Full Article

Clinuvel Pharmaceuticals says it reached an agreement with German National Association Of Statutory Health Insurance Funds
Tuesday, 11 Apr 2017 09:26pm EDT 

Clinuvel Pharmaceuticals Ltd - : Clinuvel reaches agreement on german scenesse pricing .Reached agreement with German National Association Of Statutory Health Insurance Funds for treatment of erythropoietic protoporphyria patients.  Full Article

Clinuvel Pharmaceuticals says it reached an agreement with German National Association Of Statutory Health Insurance Funds
Tuesday, 11 Apr 2017 07:40pm EDT 

Clinuvel Pharmaceuticals Ltd - : Clinuvel reaches agreement on german scenesse pricing .Reached agreement with German National Association Of Statutory Health Insurance Funds for treatment of erythropoietic protoporphyria patients.  Full Article

Clinuvel Pharmaceuticals agrees with FDA on new drug application timelines
Wednesday, 9 Nov 2016 01:51am EST 

Clinuvel Pharmaceuticals Ltd :clinuvel agrees with FDA on new drug application timelines-.  Full Article

Clinuvel Pharmaceuticals agrees with FDA on new drug application timelines
Tuesday, 8 Nov 2016 05:45pm EST 

Clinuvel Pharmaceuticals Ltd :clinuvel agrees with FDA on new drug application timelines-.  Full Article

Clinuvel Pharmaceuticals says FDA accepts Scenesse clinical data package for NDA submission
Sunday, 17 Jul 2016 08:04pm EDT 

Clinuvel Pharmaceuticals Ltd : FDA accepts scenesse® clinical data package for nda submission . Says FDA has deemed clinuvel's clinical data package satisfactory for submitting a new drug application .  Full Article

Clinuvel Pharmaceuticals says FDA awards EPP treatment drug fast track designation
Tuesday, 5 Jul 2016 06:26pm EDT 

Clinuvel Pharmaceuticals Ltd : FDA awards SCENESSE fast track designation for EPP treatment .  Full Article

Clinuvel Pharmaceuticals announces inclusion of its ADR program in NASDAQ's international designation
Wednesday, 1 Jun 2016 06:24pm EDT 

Clinuvel Pharmaceuticals Ltd : Announced the inclusion of its sponsored level 1 American depository receipt (adr) program in NASDAQ's international designation .  Full Article

BRIEF-Clinuvel Pharmaceuticals provides update on Scenesse FDA filing

* Clinuvel pharmaceuticals says ‍European post-marketing safety data to be submitted as part of new drug application, expected in december 2017​

No consensus analysis data available.