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Last $113.00 USD
Change Today 0.00 / 0.00%
Volume 0.0
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As of 8:10 PM 10/2/15 All times are local (Market data is delayed by at least 15 minutes).

santhera pharmaceuticals-reg (SPHDF) Snapshot

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09/21/15 - $137.15
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10/16/14 - $80.35
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santhera pharmaceuticals-reg (SPHDF) Details

Santhera Pharmaceuticals Holding AG, a specialty pharmaceutical company, engages in the discovery, development, and commercialization of pharmaceutical products for the treatment of mitochondrial and neuromuscular diseases in the areas of various orphan and niche indications primarily in North America and the European Union. It offers Raxone/Catena for the treatment of Leber’s Hereditary Optic Neuropathy (LHON) and Duchenne Muscular Dystrophy (DMD). The company also develops Raxone/Catena for treating patients with primary progressive Multiple Sclerosis. It also develops omigapil that is in Phase I trial for the treatment of Congenital Muscular Dystrophies. The company has a collaboration agreement with the US patient advocacy organization for a survey- based benefit/risk evaluation in DMD. Santhera Pharmaceuticals Holding AG was founded in 2004 and is headquartered in Liestal, Switzerland.

14.7 Employees
Last Reported Date: 04/14/15
Founded in 2004

santhera pharmaceuticals-reg (SPHDF) Top Compensated Officers

Chief Executive Officer and Head of the Execu...
Total Annual Compensation: SFr.426.9K
Compensation as of Fiscal Year 2014.

santhera pharmaceuticals-reg (SPHDF) Key Developments

Santhera Pharmaceuticals Prepares for German Launch of Raxone

Santhera Pharmaceuticals announced that the company is introducing Raxone in Germany. The product is intended for the treatment of Leber's Hereditary Optic Neuropathy, a rare inherited mitochondrial disease that usually leads rapidly to profound and permanent blindness. It is an oral medication, authorized at a daily dose of 900 mg (given as two tablets three times a day with food), for the treatment of visuali impairment in adolescent and adult patients with Leber's Hereditary Optic Neuropathy.

Santhera Pharmaceuticals Announces Earnings Results for the First Half of 2015

Santhera Pharmaceuticals announced earnings results for the first half of 2015. The company reported its net loss in the first half of 2015 expanded to CHF 6.2 million (EUR 5.7 million /USD 6.4 million) from CHF 3.1 million, due to higher R&D expenses, as well higher general and administrative expenses. Operating loss amounted to CHF 6 million, compared with the loss of CHF 3.1 million posted a year earlier. At the same time, net sales jumped to CHF 1.45 million from CHF 829,000 million.

Santhera Pharmaceuticals Holding AG Announces First Patient Dosing with Omigapil in Congenital Muscular Dystrophy (CMD) and Full Patient Recruitment of CALLISTO Study

Santhera Pharmaceuticals Holding AG announced that the first patient in the CALLISTO Phase I study assessing the pharmacokinetics, safety and tolerability of oral omigapil in patients with Congenital Muscular Dystrophy (CMD) has been dosed and all participating patients have been recruited. This study, which is being conducted at the US National Institutes of Health (NIH), will also evaluate the feasibility of conducting disease-relevant clinical assessments that could be used as endpoints in future efficacy trials in pediatric and adolescent CMD patients. The study is being conducted at the NIH's National Institute of Neurological Disorders and Stroke (NINDS) in Bethesda, Maryland, and will evaluate use of the compound in 20 ambulatory and non-ambulatory patients aged 5 to 16 years affected by either Ullrich or MDC1A subtypes of CMD. All patients have been selected, pre-screened and randomly assigned to one of the three study cohorts that are starting sequentially with ascending doses of omigapil. Following a 4-week vehicle run-in phase, each patient will receive one of three doses of omigapil (0.02, 0.08 or 0.2 mg/kg/day) for 12 weeks, during which period the pharmacokinetics of omigapil will be assessed as well as the patients' respiratory function, muscle strength and motor function. To ensure the collection of as much information as possible from both subtypes of CMD, Ullrich or MDC1A, all patients have been identified and randomized prior to the first dosing. The first patient received the starting dose of 0.02 mg/kg/day, applied in a new liquid formulation developed by Santhera for this patient population. Only after an independent data and safety monitoring board (DSMB) has assessed the pharmacokinetic and safety data in each completed cohort, dosing in subsequent cohorts will follow at ascending doses. Due to the staggered dosing of patients, the study is expected to run until the end of 2016.


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