Santhera Pharmaceuticals AG
Im Neuenheimer Feld 518 - 519
Heidelberg
69120
Germany
Tel: 49-0-6221-649-33-0
Fax: 49-0-6221-649-3311
Website: http://www.santhera.com/
120 articles about Santhera Pharmaceuticals AG
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Santhera’s Shareholders Approve all Board Proposals at Today’s Annual General Meeting
5/28/2019
Participating shareholders represented a total of 4’109’097 shares or 36.8% of the share capital.
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Santhera Submits Marketing Authorization Application to the European Medicines Agency for Puldysa® (Idebenone) in Duchenne Muscular Dystrophy
5/27/2019
Santhera Pharmaceuticals (SIX: SANN) announces that it has submitted a marketing authorization application (MAA) for Puldysa® (idebenone) for the treatment of respiratory dysfunction in patients with Duchenne muscular dystrophy (DMD) to the European Medicines Agency (EMA).
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Santhera Enters into License Agreement with Chiesi Group for Raxone® in LHON Valued at up to CHF 105 Million
5/23/2019
Santhera Pharmaceuticals (SIX: SANN) announces that it has entered into an exclusive license agreement with Chiesi Farmaceutici, an international research-focused healthcare group (Chiesi Group), under which Chiesi Group will in-license Raxone® for the treatment of LHON for a total consideration of up to CHF 105 million
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Santhera Starts Collaboration in Gene Therapy Research for Congenital Muscular Dystrophy with the Biozentrum, University of Basel, Co-Financed by Innosuisse
5/21/2019
Santhera Pharmaceuticals (SIX: SANN) announces its collaboration with the Biozentrum of the University of Basel to advance gene therapy research for the treatment of LAMA2-deficient congenital muscular dystrophy (LAMA2 MD or MDC1A)
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Santhera Reports Strong Top-line Growth for 2018 and the Successful Expansion of its Rare Disease Pipeline
4/29/2019
Santhera Pharmaceuticals (SIX: SANN) announces the Group’s audited financial results for 2018.
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Santhera to Present Long-term Efficacy Results with Idebenone in DMD at the 2019 MDA Clinical and Scientific Conference
4/16/2019
Santhera Pharmaceuticals (SIX: SANN) and its collaborating clinical experts present results of long-term efficacy on respiratory function outcomes in idebenone-treated patients with Duchenne muscular dystrophy (DMD) at the 2019 Muscular Dystrophy Association (MDA) Clinical and Scientific Conference held in Orlando, USA, April 13-17, 2019.
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Santhera Raises up to CHF 22.1 Million by Placement of Shares and Credit Line
4/4/2019
Santhera Pharmaceuticals (SIX: SANN) announces that it has placed all of the remaining 500,000 registered shares from its existing authorized share capital in a private placement, resulting in aggregate gross proceeds of CHF 7.1 million.
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Santhera Provides Update on Near-term Corporate Financing Initiatives
4/3/2019
Santhera Pharmaceuticals (SIX: SANN) announces that it has entered into a CHF 15.0 million credit line facility and is providing an update on ongoing corporate financing initiatives, including the issuance of equity and business development opportunities that would strengthen the financial base of the Company.
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Santhera Provides Update on Filing for Conditional Marketing Authorization in Europe for Puldysa® (Idebenone) in Duchenne Muscular Dystrophy
3/28/2019
Santhera Pharmaceuticals (SIX: SANN) announces its intention to file an application for Conditional Marketing Authorization (CMA) for Puldysa® (idebenone) for the treatment of respiratory dysfunction in Duchenne muscular dystrophy (DMD) with the European Medicines Agency (EMA).
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Santhera Completes Patient Enrollment in Phase IV Long-term Study with Raxone® for the Treatment of Leber’s Hereditary Optic Neuropathy
3/12/2019
Results from the 24-month active treatment study conducted in 31 study centers in Europe and the USA are expected in 2021.
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Santhera’s SYROS Study Shows Long-term Efficacy with Idebenone in Slowing Respiratory Function Loss in Patients with Duchenne Muscular Dystrophy
2/25/2019
Santhera Pharmaceuticals (SIX: SANN) announces results from the SYROS study demonstrating that long-term treatment with idebenone consistently reduced the rate of respiratory function loss in patients with Duchenne muscular dystrophy (DMD) for up to 6 years in a real-world setting.
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Santhera Announces Start of Phase Ib/IIa Trial with POL6014 in Patients with Cystic Fibrosis
10/24/2018
Santhera Pharmaceuticals announces the start of a Phase Ib/IIa multiple ascending dose (MAD) trial with POL6014 in patients with cystic fibrosis (CF).
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Santhera Receives Positive Opinion for Orphan Drug Designation in the EU for POL6014 in Cystic Fibrosis
10/15/2018
Santhera Pharmaceuticals announces that the Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency (EMA) has issued a positive opinion on orphan drug designation for POL6014 in the treatment of cystic fibrosis (CF), a rare pulmonary disease affecting around 35,000 people in the European Union.
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Santhera to Report First Half-Year Financial Figures and Provide Corporate Update on September 4, 2018
8/21/2018
Santhera Pharmaceuticals (SIX: SANN) will announce its first half-year financial figures for 2018 and provide a corporate update on Tuesday, September 4, 2018, at 07:00 CEST / 06:00 BST / 01:00 EDT.
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Santhera Obtains Worldwide Exclusive License from Polyphor to Develop and Commercialize Clinical Stage Candidate for Cystic Fibrosis and Other Pulmonary Diseases
2/15/2018
Santhera will assume the global development, regulatory filings and commercialization of POL6014.
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Santhera Launches U.S. Expanded Access Program with Idebenone for Patients With Duchenne Muscular Dystrophy (DMD)
2/6/2018
Eligible patients with DMD who are 10 years and older and in respiratory function decline, can obtain access to investigational idebenone, at no cost, through a growing network of research centers across the U.S.
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Santhera Reports Preliminary Key Financial Figures for 2017 and Provides Corporate Update
1/29/2018
The Company announces preliminary, unaudited key financial figures for 2017.
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Santhera Receives Negative CHMP Opinion on Appeal for Authorization of Raxone in Duchenne Muscular Dystrophy
1/26/2018
The CHMP concluded that an approval for Raxone in DMD, applied as a Type II variation of the existing marketing authorization, cannot be granted at the present time based on the current existing evidence
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Santhera Anticipates Receiving a Negative CHMP Opinion on Appeal for Marketing Authorization Application for Raxone in Duchenne Muscular Dystrophy
1/24/2018
Santhera will provide further update on Friday, January 26, as originally announced.
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Santhera Plans to Announce Regulatory Feedback for Raxone in DMD and 2017 Preliminary Key Financial Figures
1/19/2018
Santhera expects to receive an opinion by the CHMP of the EMA for its MAA filed as Type II extension application for Raxone in DMD by January 26.