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Ad hoc announcement pursuant to Art. 53 LR A conference call will be held on April 25, 2024, at 14:30 CEST / 13:30 BST / 08:30 EDT. Details are at the end of this news release. Santhera Announces Preliminary Unaudited 2023 Annual Results and Provides Corporate Update Ahead of Full R...
2024-03-31 04:50:00 ET Summary South Korea’s AriBio out-licensed China rights for AR1001, an Alzheimer’s disease candidate, in an agreement worth up to $770M. AnHeart Therapeutics, a New York-Hangzhou biopharma, will become part of Nuvation Bio (NYSE: NUVB) of New Yo...
Pratteln, Switzerland, March 27, 2024 – Santhera Pharmaceuticals (SIX: SANN) announces that the China National Medical Products Administration (NMPA) has accepted for priority review the new drug application (NDA) for vamorolone in Duchenne muscular dystrophy (DMD) which was submitted...
AGAMREE® is U.S. FDA approved and now available in the United States for the treatment of Duchenne muscular dystrophy (DMD) in patients 2 years of age and older This follows the first commercial launch of AGAMREE in Germany in January 2024 by Santhera AGAMREE is the first DMD...
Results from 112 patients with DMD who completed the study confirm maintenance of efficacy and benefits in safety and tolerability of treatment with vamorolone over 48 weeks AGAMREE® has shown safety benefits in patients switching from standard of care corticosteroids in terms of rec...
AGAMREE® is the only approved medication in the European Union (EU) for treating all patients from age 4 years with DMD, and the first DMD treatment approved across the U.S., EU and UK This marks the first commercial launch of AGAMREE® globally Pratteln, Switzerland, J...
Approval by the Medicines and Healthcare products Regulatory Agency (MHRA) of AGAMREE® in the United Kingdom follows marketing authorization for this medicine in the EU and U.S. MHRA acknowledges safety benefits of AGAMREE with regards to preserving bone health and maintaining growth...
European Commission (EC) grants marketing authorization for AGAMREE® for the treatment of Duchenne muscular dystrophy (DMD) in patients aged 4 years and older AGAMREE® is the only approved medication in the European Union (EU) for treating DMD, and the first DMD treatment approv...
Pratteln, Switzerland, December 7, 2023 – Santhera Pharmaceuticals (SIX: SANN) announces the promotion of Geert Jan van Daal, MD, PhD, to Chief Commercial Officer (CCO) and of Marc Schrader to Chief Technology Officer (CTO). Both will join the six-member Executive Committee effective ...
Ad hoc announcement pursuant to Art. 53 LR Food and Drug Administration (FDA) approved AGAMREE® (vamorolone) for the treatment of Duchenne muscular dystrophy (DMD) in children and adults aged 2 years and older U.S. license holder Catalyst Pharmaceuticals plans for commercial ...
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Ad hoc announcement pursuant to Art. 53 LR A conference call will be held on April 25, 2024, at 14:30 CEST / 13:30 BST / 08:30 EDT. Details are at the end of this news release. Santhera Announces Preliminary Unaudited 2023 Annual Results and Provides Corporate Update Ahead of Full R...
Pratteln, Switzerland, March 27, 2024 – Santhera Pharmaceuticals (SIX: SANN) announces that the China National Medical Products Administration (NMPA) has accepted for priority review the new drug application (NDA) for vamorolone in Duchenne muscular dystrophy (DMD) which was submitted...
AGAMREE® is U.S. FDA approved and now available in the United States for the treatment of Duchenne muscular dystrophy (DMD) in patients 2 years of age and older This follows the first commercial launch of AGAMREE in Germany in January 2024 by Santhera AGAMREE is the first DMD...