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Santhera Pharmaceuticals Holding AG (SANN.S)

SANN.S on Swiss Exchange

31.00CHF
14 Dec 2017
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Latest Key Developments (Source: Significant Developments)

Santhera: negative opinion from the CHMP for Raxone in DMD
Friday, 15 Sep 2017 01:01am EDT 

Sept 15 (Reuters) - SANTHERA PHARMACEUTICALS HOLDING AG ::SANTHERA RECEIVES NEGATIVE OPINION FROM THE CHMP FOR ITS MARKETING AUTHORIZATION APPLICATION FOR RAXONE® IN DMD AND INTENDS TO APPEAL THIS OPINION.‍WILL SEEK A RE-EXAMINATION BY CHMP​.‍CHMP EXPRESSED UNCERTAINTIES WHETHER PHASE III DELOS TRIAL PROVIDES SUFFICIENT EVIDENCE OF EFFICACY​.  Full Article

Santhera Pharmaceuticals Holding H1 net loss widens to CHF 22.7 million
Tuesday, 5 Sep 2017 01:00am EDT 

Sept 5 (Reuters) - SANTHERA PHARMACEUTICALS HOLDING AG ::‍1H 2017 SALES OF CHF 10.9 MILLION, INCREASE OF 51% COMPARED TO 1H 2016​.H1 ‍NET SALES OF RAXONE AMOUNTED TO CHF 10.9 MILLION (1H 2016: CHF 7.2 MILLION)​.‍OPERATING EXPENSES IN FIRST HALF-YEAR WERE CHF 30.5 MILLION (1H 2016: CHF 22.6 MILLION)​.H1 ‍DEVELOPMENT EXPENSES OF CHF 11.7 MILLION (1H 2016: CHF 8.1 MILLION)​.‍OPERATING LOSS IN FIRST HALF OF THIS YEAR AMOUNTED TO CHF 21.4 MILLION (1H 2016: CHF -17.2 MILLION).H1 ‍NET RESULT OF CHF -22.7 MLN (1H 2016: CHF -18.0 MLN).‍REITERATES ITS REVENUE OUTLOOK AND CURRENTLY EXPECTS NET SALES OF RAXONE FOR FULL YEAR 2017 TO REACH CHF 21 TO 23 MLN​​​.  Full Article

Santhera announces approval of Raxone for LHON in Israel
Thursday, 31 Aug 2017 01:01am EDT 

Aug 31 (Reuters) - SANTHERA PHARMACEUTICALS HOLDING AG ::SANTHERA ANNOUNCES APPROVAL OF RAXONE FOR LHON IN ISRAEL.  Full Article

Santhera expects CHMP opinion about Raxone in Q3 2017
Friday, 19 May 2017 01:00am EDT 

May 19 (Reuters) - SANTHERA PHARMACEUTICALS HOLDING AG :PROVIDES UPDATE ON TIMELINE FOR APPLICATION OF RAXONE® IN DUCHENNE MUSCULAR DYSTROPHY IN EUROPE.WE ARE NOW EXPECTING TO RECEIVE A REQUEST FOR SUPPLEMENTARY INFORMATION TO FURTHER SUPPORT CLINICAL RELEVANCE OF OUR DATA.WE ARE WORKING CLOSELY WITH CHMP TO CONCLUDE APPLICATION PROCESS AND ANTICIPATE AN OPINION IN Q3 2017.  Full Article

Santhera signs distribution and supply agreement for Raxone for Greece and Cyprus
Tuesday, 2 May 2017 01:00am EDT 

May 2 (Reuters) - Santhera Pharmaceuticals Holding AG :Santhera signs distribution and supply agreement for Raxone (idebenone) with Pharmathen for Greece and Cyprus.  Full Article

Santhera Pharmaceuticals FY revenues of CHF 19.0 million
Tuesday, 7 Mar 2017 01:00am EST 

Santhera Pharmaceuticals Holding AG : FY net revenues of 19.0 million Swiss francs ($18.79 million) (+340 pct year-on-year) from sales of its lead product Raxone for treatment of Leber's hereditary optic neuropathy (LHON) . FY operating result amounted to -33.1 million francs (2015 comparable: -23.9 million francs) and net result was -35.4 million francs . Cash and cash equivalents by end of February 2017 amounted to 100.8 million francs . FY group net result in 2016 amounted to -35.4 million francs (2015: 5.9 million francs) .Company expects 2017 net sales of Raxone in currently approved indication alone to reach 21 to 23 million francs.  Full Article

Santhera Pharmaceuticals: CHF 49.8 mln in cash and cash equivalents by end of 2016
Thursday, 26 Jan 2017 01:00am EST 

Santhera Pharmaceuticals Holding AG : Reports FY net revenues of 19.0 million Swiss francs ($19.02 million)(+340% year-on-year) from sales of its lead product Raxone for treatment of leber's hereditary optic neuropathy (LHON) . By end of 2016 Santhera held 49.8 million Swiss francs in cash and cash equivalents (end of 2015: 76.9 million francs). . For 2016, company expects a net result of -33 million to -38 million Swiss francs .For 2017, Santhera expects net sales of Raxone for currently approved indication to reach 21 million to 23 million Swiss francs.  Full Article

Santhera's Raxone designated promising innovative medicine in UK
Friday, 23 Dec 2016 01:00am EST 

Santhera Pharmaceuticals Holding AG :Raxone designated promising innovative medicine and suitable candidate for further evaluation under U.K. Early Access To Medicines Scheme (EAMS) for treatment in duchenne muscular dystrophy.  Full Article

Santhera announces appointment of Kristina Timdahl as Chief Medical Officer
Tuesday, 4 Oct 2016 01:01am EDT 

Santhera Pharmaceuticals Holding AG : Santhera announces appointment of Kristina Timdahl as Chief Medical Officer and head of development as of January 2017 .Will replace Nick Coppard, who will retire in January 2017.  Full Article

Santhera Pharmaceuticals Holding H1 net loss widens to CHF 18 million
Tuesday, 6 Sep 2016 01:00am EDT 

Santhera Pharmaceuticals Holding AG : As of June 30, 2016, Santhera had cash and cash equivalents of 63.6 million Swiss francs ($64.89 million) (December 31, 2015: 76.9 million francs) . H1 operating loss amounted to 17.2 million francs (H1 2015: -6.2 million francs) leading to a net result of -18.0 million francs (H1 2015: -6.4 million francs) .Expects net sales of Raxone in 2016 to reach 16 to 18 million francs.  Full Article

BRIEF-Santhera: negative opinion from the CHMP for Raxone in DMD

* SANTHERA RECEIVES NEGATIVE OPINION FROM THE CHMP FOR ITS MARKETING AUTHORIZATION APPLICATION FOR RAXONE® IN DMD AND INTENDS TO APPEAL THIS OPINION