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Santhera Pharmaceuticals Holding AG (SANN.SW)

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Santhera Announces NDA for Vamorolone in Duchenne Muscular Dystrophy Accepted and Granted Priority Review by China’s NMPA

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 by Sperogenix Therapeutics, Santhera's specialized rare disease partner for China. The Center for Drug Evaluation (CDE) of the Chinese drug authority NMPA accepted the filing and granted priority review for vamorol

GlobeNewswire 23 days ago

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Santhera’s Partner Catalyst Pharmaceuticals Launches AGAMREE® (Vamorolone) in the United States

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 olderThis follows the first commercial launch of AGAMREE in Germany in January 2024 by SantheraAGAMREE is the first DMD treatment approved across the U.S., EU and UK Pratteln, Switzerland, March 14, 2024 – Santhera Pharmaceuticals (SIX: SANN) is pleased to note the launch of AGAMREE® (vamorolone) for the treatment of Duchenne muscular dystroph

GlobeNewswire last month

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Santhera Announces Publication of Efficacy, Safety and Tolerability Data with Vamorolone (AGAMREE®) in Patients with Duchenne Muscular Dystrophy in Neurology

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 recovery of bone health and growth More than 200 patients have now been treated with vamorolone for up to 84 months across clinical studies and access programs AGAMREE® is the only approved medication in the European Un

GlobeNewswire 2 months ago

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Santhera Launches AGAMREE® (Vamorolone) in Germany as First Market for the Treatment of Duchenne Muscular Dystrophy

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 UKThis marks the first commercial launch of AGAMREE® globally Pratteln, Switzerland, January 15, 2024 – Santhera Pharmaceuticals (SIX: SANN) announces the launch of AGAMREE® (vamorolone) for the treatment of Duchenne muscular dystrophy (DMD) in patients 4 years of age and older, irrespective of the underlying mutatio

GlobeNewswire 3 months ago

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Santhera Receives Approval for AGAMREE® (Vamorolone) as a Treatment for Duchenne Muscular Dystrophy in the United Kingdom

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 compared to standard of care corticosteroidsLaunches of AGAMREE in Europe, with Germany taking the lead, are planned to start in Q1-2024 Pratteln, Switzerland, January 12, 2024 – Santhera Pharmaceuticals (SIX: SANN)

GlobeNewswire 3 months ago

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Santhera’s AGAMREE® (Vamorolone) Approved in the European Union for the Treatment of Duchenne Muscular Dystrophy

European Commission (EC) grants marketing authorization for AGAMREE® for the treatment of Duchenne muscular dystrophy (DMD) in patients aged 4 years and olderAGAMREE® is the only approved medication in the European Union (EU) for treating DMD, and the first DMD treatment approved in both the U.S. and EUFirst commercial launch of AGAMREE®, in Germany, expected in Q1-2024 EMA acknowledges safety benefits of AGAMREE® with regards to preserving bone health and maintaining growth compared to standard

GlobeNewswire 3 months ago

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Santhera Appoints Executive Committee Members as it Transitions into Commercial Stage

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 January 1, 2024. “Santhera is transitioning to the commercial phase and will make AGAMREE® (vamorolone) available to patients in Europe starting in Germany in early 2024, subject to approval by the European Commissi

GlobeNewswire 4 months ago

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Santhera Receives U.S. FDA Approval of AGAMREE® (vamorolone) for the Treatment of Duchenne Muscular Dystrophy

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 olderU.S. license holder Catalyst Pharmaceuticals plans for commercial launch in Q1-2024FDA approval triggers USD 36 million payment obligation from Catalyst to Santhera, of which USD 26 million will be used to cover Santhera’s third-party milestone obligationsFollowing the recent positive CHMP

GlobeNewswire 5 months ago

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Santhera Receives Positive CHMP Opinion Recommending Approval of AGAMREE® (vamorolone) for the Treatment of Duchenne Muscular Dystrophy

Ad hoc announcement pursuant to Art. 53 LR Committee for Medicinal Products for Human Use (CHMP) issues positive opinion for AGAMREE® (vamorolone) for the treatment Duchenne muscular dystrophy (DMD) in children and adults aged 4 years and olderEuropean Commission (EC) decision on marketing authorization is expected in late 2023AGAMREE could become the first drug fully approved by the European Medicines Agency (EMA) for the treatment of patients with DMD Anticipation of vamorolone approval in the

GlobeNewswire 6 months ago

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Santhera Announces Half-Year 2023 Financial Results and Provides Corporate Update

Ad hoc announcement pursuant to Art. 53 LR A conference call will be held today at 14:30 CEST / 13:30 BST / 08:30 EDT. Details are at the end of this news release. Revenue from contracts with customers of CHF 3.9 million (H1-2022: CHF 6.3 million)Operating result of CHF -20.3 million (H1-2022: CHF -25.5 million) and net result of CHF -23.3 million (H1-2022: CHF -29.7 million)Review of vamorolone's regulatory filings (NDA, MAA) for Duchenne muscular dystrophy (DMD) treatment proceeding as planned

GlobeNewswire 7 months ago

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Santhera Completes Divestment of Raxone®/Idebenone Business to Chiesi Group

Ad hoc announcement pursuant to Art. 53 LR Chiesi Group acquires entire idebenone business including Raxone in Leber's hereditary optic neuropathy (LHON)Chiesi Group assumes French reimbursement liability of EUR 25.3 million from SantheraSanthera retains contingent value for LHON in U.S. and/or other indications worldwideSanthera ceases all Raxone-related activities and intensifies commercial preparation for Duchenne muscular dystrophy candidate vamorolone in Europe Pratteln, Switzerland, July 3

GlobeNewswire 8 months ago

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Santhera Announces Closing of Exclusive North America License Agreement with Catalyst Pharmaceuticals for Vamorolone

Ad hoc announcement pursuant to Art. 53 LR Pratteln, Switzerland, July 19, 2023 – Santhera Pharmaceuticals (SIX: SANN) announces the closing of the exclusive license agreement for vamorolone in North America (NA) with Catalyst Pharmaceuticals, Inc. (NASDAQ: CPRX), announced on June 20, 2023 [1]. The proceeds from the agreement extend Santhera’s cash reach into 2025. Together with the expected income from ongoing operations, it provides funding for the pre-commercialization and launch of vamorolo

GlobeNewswire 8 months ago

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Santhera Publishes Timeline of the Reverse Share Split

NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION IN THE UNITED STATES OR ANY OTHER JURISDICTION IN WHICH IT WOULD BE UNLAWFUL TO DO SO. Ad hoc announcement pursuant to Art. 53 LR Pratteln, Switzerland, June 29, 2023 – Santhera Pharmaceuticals (SIX: SANN) announces the timeline of the reverse share split in the ratio 10:1 which was approved by shareholders at the Annual General Meeting held on June 27, 2023, with a large majority. June 30, 2023: Last trading day of old shares (ISIN: CH0027148649) on

GlobeNewswire 9 months ago

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Shareholders Approve all Board Proposals at Today’s Annual General Meeting

Pratteln, Switzerland, June 27, 2023 – Santhera Pharmaceuticals (SIX: SANN) announces that its shareholders approved all motions by the Board of Directors at the Annual General Meeting (AGM) held today in Pratteln, Switzerland, with a large majority. Participating shareholders represented a total of 26’037’561 shares or 20.7% of the Company’s share capital. Approval of the 2022 Annual Report and discharge of corporate bodiesThe shareholders approved the Annual Report, the annual financial statem

GlobeNewswire 9 months ago

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Catalyst Pharmaceuticals to License North American Rights to Vamorolone for Duchenne Muscular Dystrophy from Santhera Pharmaceuticals

Vamorolone is Currently Under Review with the FDA (PDUFA Date of October 26, 2023) for the Treatment of Duchenne Muscular Dystrophy, a Rare Neuromuscular Disease FDA has Granted Fast Track and Orphan Drug Designation for Vamorolone to Treat Duchenne Muscular Dystrophy Catalyst Expects to Launch Vamorolone in the U.S. Early in Q1 2024, Subject to Regulatory Approval by the PDUFA Date Agreement to Include Commercial and Future Development Rights for Vamorolone for Additional Indications in North A

GlobeNewswire 9 months ago

CPRX

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Santhera Grants Exclusive North America License for Vamorolone to Catalyst Pharmaceuticals in Deal Valued at up to USD 231 Million Plus Royalties

Ad hoc announcement pursuant to Art. 53 LR A conference call will be held today at 14:30 CEST / 13:30 BST / 08:30 EDT. Details are at the end of this news release. Santhera will receive USD 90 million upfront at closing (USD 75 million in cash and USD 15 million equity investment), an additional USD 10 million upon U.S. FDA approval of vamorolone in Duchenne muscular dystrophy (DMD) plus USD 26 million to pay approval related regulatory milestones to third parties, and potential sales milestones

GlobeNewswire 9 months ago

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Santhera Publishes Agenda for its Annual General Meeting

NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION IN THE UNITED STATES OR ANY OTHER JURISDICTION IN WHICH IT WOULD BE UNLAWFUL TO DO SO. Ad hoc announcement pursuant to Art. 53 LR Pratteln, Switzerland, June 6, 2023 – Santhera Pharmaceuticals (SIX: SANN) today published the agenda for its Annual General Meeting (AGM), which will be held on June 27, 2023, at 10:00 CEST at Haus der Wirtschaft, Hardstrasse 1, 4133 Pratteln, Switzerland. The invitation to the Annual General Meeting with agenda items and

GlobeNewswire 10 months ago

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Santhera Publishes Annual Report 2022

Ad hoc announcement pursuant to Art. 53 LR Pratteln, Switzerland, May 31, 2023 – Santhera Pharmaceuticals (SIX: SANN) announces the publication of its Annual Report 2022 with fully audited results for the year ended December 31, 2022. Santhera’s Annual Report 2022 provides comprehensive and detailed information on the Company, its strategy, business, financial performance, governance and compensation in 2022, and confirms the preliminary unaudited 2022 annual results which were published on Apri

GlobeNewswire 10 months ago

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Santhera Announces Preliminary Unaudited 2022 Annual Results Ahead of Full Report Publication by End of May and Provides Corporate Update

Ad hoc announcement pursuant to Art. 53 LR A conference call will be held on April 27, 2023, at 14:30 CEST / 13:30 BST / 08:30 EDT. Details are at the end of this news release. Revenue from contracts with customers of CHF 7.5 million (2021: CHF -1.6 million)Operating result of CHF -52.0 million (2021: CHF -56.9 million) and net result of CHF -70.1 million (2021: CHF -55.5 million)Cash and cash equivalents of CHF 1.4 million (December 31, 2022), together with existing financing facilities, enable

GlobeNewswire 11 months ago

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Vamorolone NDA mid-cycle review meeting by FDA completed

Pratteln, Switzerland, and Rockville, MD, USA, April 25, 2023 – Santhera Pharmaceuticals (SIX: SANN) and ReveraGen BioPharma, Inc announce the successful completion of the mid-cycle review meeting by the U.S. Food and Drug Administration (FDA) of the new drug application (NDA) for vamorolone for the treatment of Duchenne muscular dystrophy (DMD). At the recent mid-cycle review meeting, the FDA indicated that no significant review or safety concerns were noted up to that point in their ongoing re

GlobeNewswire 11 months ago

SPHDF

Performance Overview

Return	SANN.SW	MSCI WORLD
YTD	-5.10%	+3.32%
1-Year	+46.38%	+15.47%
3-Year	-64.93%	0.00%

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Santhera Pharmaceuticals Holding AG (SANN.SW)

Santhera Announces NDA for Vamorolone in Duchenne Muscular Dystrophy Accepted and Granted Priority Review by China’s NMPA

Santhera’s Partner Catalyst Pharmaceuticals Launches AGAMREE® (Vamorolone) in the United States

Santhera Announces Publication of Efficacy, Safety and Tolerability Data with Vamorolone (AGAMREE®) in Patients with Duchenne Muscular Dystrophy in Neurology

Santhera Launches AGAMREE® (Vamorolone) in Germany as First Market for the Treatment of Duchenne Muscular Dystrophy

Santhera Receives Approval for AGAMREE® (Vamorolone) as a Treatment for Duchenne Muscular Dystrophy in the United Kingdom

Santhera’s AGAMREE® (Vamorolone) Approved in the European Union for the Treatment of Duchenne Muscular Dystrophy

Santhera Appoints Executive Committee Members as it Transitions into Commercial Stage

Santhera Receives U.S. FDA Approval of AGAMREE® (vamorolone) for the Treatment of Duchenne Muscular Dystrophy

Santhera Receives Positive CHMP Opinion Recommending Approval of AGAMREE® (vamorolone) for the Treatment of Duchenne Muscular Dystrophy

Santhera Announces Half-Year 2023 Financial Results and Provides Corporate Update

Santhera Completes Divestment of Raxone®/Idebenone Business to Chiesi Group

Santhera Announces Closing of Exclusive North America License Agreement with Catalyst Pharmaceuticals for Vamorolone

Santhera Publishes Timeline of the Reverse Share Split

Shareholders Approve all Board Proposals at Today’s Annual General Meeting

Catalyst Pharmaceuticals to License North American Rights to Vamorolone for Duchenne Muscular Dystrophy from Santhera Pharmaceuticals

Santhera Grants Exclusive North America License for Vamorolone to Catalyst Pharmaceuticals in Deal Valued at up to USD 231 Million Plus Royalties

Santhera Publishes Agenda for its Annual General Meeting

Santhera Publishes Annual Report 2022

Santhera Announces Preliminary Unaudited 2022 Annual Results Ahead of Full Report Publication by End of May and Provides Corporate Update

Vamorolone NDA mid-cycle review meeting by FDA completed

Performance Overview