Santhera Pharmaceuticals AG
Im Neuenheimer Feld 518 - 519
118 articles about Santhera Pharmaceuticals AG
Santhera Announces Publication of Efficacy, Safety and Tolerability Data with Vamorolone (AGAMREE®) in Patients with Duchenne Muscular Dystrophy in Neurology
Santhera Pharmaceuticals announces the publication of the paper “Efficacy and Safety of Vamorolone Over 48 Weeks in Boys With Duchenne Muscular Dystrophy” in the peer-reviewed journal Neurology.
Pratteln, Switzerland, December 7, 2023 – Santhera Pharmaceuticals announces the promotion of Geert Jan van Daal, MD, PhD, to Chief Commercial Officer and of Marc Schrader to Chief Technology Officer.
Santhera Pharmaceuticals and partner Catalyst Pharmaceuticals got the FDA’s greenlight for their Duchenne muscular dystrophy drug Agamree, which is expected to launch in the first quarter of 2024.
The FDA is gearing up for six decisions in the next two weeks, two of which involve highly anticipated medicines for rare diseases.
Santhera Pharmaceuticals announces the Company’s financial results for the six months ended June 30, 2023, reports on the regulatory and clinical progress with its lead drug candidate vamorolone for the treatment of DMD, and provides updates on its corporate and financing initiatives.
The first half of this year saw milestone approvals for rare disease therapies, and the FDA has several more such decisions on its calendar in the second half of 2023.
Santhera Announces Closing of Exclusive North America License Agreement with Catalyst Pharmaceuticals for Vamorolone
Santhera Pharmaceuticals announces the closing of the exclusive license agreement for vamorolone in North America with Catalyst Pharmaceuticals, Inc., announced on June 20, 2023.
Catalyst Pharmaceuticals Acquires Exclusive North American License For Vamorolone for Duchenne Muscular Dystrophy from Santhera Pharmaceuticals
Catalyst Pharmaceuticals, Inc., announced the completion of its acquisition from Santhera Pharmaceuticals Holdings of an exclusive license for North America for vamorolone, a potential treatment for patients suffering with Duchenne Muscular Dystrophy.
Santhera Pharmaceuticals announces that its shareholders approved all motions by the Board of Directors at the Annual General Meeting held in Pratteln, Switzerland, with a large majority.
Santhera Grants Exclusive North America License for Vamorolone to Catalyst Pharmaceuticals in Deal Valued at up to USD 231 Million Plus Royalties
Santhera Pharmaceuticals announces that it has signed an exclusive license and collaboration agreement for vamorolone in North America with Catalyst Pharmaceuticals, Inc., a commercial-stage biopharmaceutical company focused on novel medicines for patients living with rare diseases.
Catalyst Pharmaceuticals to License North American Rights to Vamorolone for Duchenne Muscular Dystrophy from Santhera Pharmaceuticals
Catalyst Pharmaceuticals, Inc. announced that Catalyst has entered into a definitive agreement with Santhera Pharmaceuticals Holding under which Catalyst will enter into an exclusive North America license, manufacturing and supply agreement for Santhera’s investigational product candidate, vamorolone, a dissociative steroid currently under FDA review for the treatment of Duchenne Muscular Dystrophy.
Santhera Pharmaceuticals announces the publication of its Annual Report 2022 with fully audited results for the year ended December 31, 2022.
Santhera Announces Preliminary Unaudited 2022 Annual Results Ahead of Full Report Publication by End of May and Provides Corporate Update
Santhera Pharmaceuticals announces the Company’s preliminary unaudited financial results for the year ended December 31, 2022, reports on progress with its lead drug candidate vamorolone for the treatment of DMD in the U.S. and Europe, and provides updates on its strategic and financing initiatives.As permitted by SIX Exchange Regulation, the Company will publish the full 2022 Annual Report by the end of May.
Santhera Pharmaceuticals and ReveraGen BioPharma, Inc announce the successful completion of the mid-cycle review meeting by the U.S. Food and Drug Administration of the new drug application for vamorolone for the treatment of Duchenne muscular dystrophy.
Santhera Submits Marketing Authorization Application to the UK MHRA for Vamorolone in Duchenne Muscular Dystrophy
Santhera Pharmaceuticals announces that it has submitted a marketing authorization application to the UK Medicines and Healthcare products Regulatory Agency for vamorolone for the treatment of Duchenne muscular dystrophy.
Santhera Concludes Agreement with French Authorities on Raxone® Reimbursement and Plans to Submit a Request for an Early Access Program for Vamorolone
Santhera Pharmaceuticals announces that it has secured a finalreimbursement agreement with the French authorities related to Raxone®for the treatment of Leber's hereditary optic neuropathy and sales are expected to resume shortly.
Santhera Pharmaceuticals announces that through a share exchange it will receive the equivalent of CHF 5 million Idorsia shares whichSanthera is free to sell at its own discretion in support of its short-term financial needs.
Santhera Pharmaceuticals and ReveraGen BioPharma, Inc announce that they have completed the rolling submission of a new drug application to the U.S. Food and Drug Administration,seeking priority review for vamorolonefor the treatment of Duchenne muscular dystrophy.
Santhera Announces Preliminary 2022 Half-year Financial Results Ahead of Full Report Publication by End of October
Santhera Pharmaceuticals publishes preliminary financial results for the half-year ended June 30, 2022.
JAMA Neurology Publishes Positive Pivotal Clinical Trial with Vamorolone in Duchenne Muscular Dystrophy
Santhera Pharmaceuticals and ReveraGen announce that JAMA Neurology has published positive results of the 24-week primary efficacy and safety analysis from the VISION-DMD study evaluating vamorolone, an investigational drug for the treatment Duchenne muscular dystrophy.