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Santhera has begun launch preparations for AGAMREE® in UK with first sales expected in this quarter Pratteln, Switzerland, January 16, 2025 – Santhera Pharmaceuticals (SIX: SANN) announces that the National Institute for Health and Care Excellence (NICE) has issued positive Final Guidance that recommends AGAMREE® (vamorolone) for use in the National Health Service (NHS) in England, Wales and Northern Ireland for the treatment of Duchenne muscular dystrophy (DMD) in patients 4 years of age...

Santhera Receives Positive Recommendation from Scottish Medicines Consortium for the Use of AGAMREE® (Vamorolone) in Duchenne Muscular Dystrophy Patients in NHS Scotland AGAMREE® is approved by MHRA for treating Duchenne muscular dystrophy (DMD) in patients 4 years of age and older in UK Pratteln, Switzerland, January 14, 2025 – Santhera Pharmaceuticals (SIX: SANN) announces that the Scottish Medicines Consortium (SMC) has published recommendations that AGAMREE® (vamorolone) is accepted for...

Pratteln, Switzerland, January 6, 2025 – Santhera Pharmaceuticals (SIX: SANN) announces the signing of an exclusive agreement with Clinigen Group to manage the supply and distribution of AGAMREE® (vamorolone) in countries where the product is not otherwise commercially available. Santhera Pharmaceuticals and Clinigen Group announce that they have signed a Supply and Distribution Agreement for AGAMREE in countries where the product can currently not be commercially obtained via Santhera or one...

Santhera Receives Positive Recommendation from NICE for AGAMREE® (Vamorolone) as a Treatment for Duchenne Muscular Dystrophy AGAMREE® has been recommended by NICE for treating Duchenne muscular dystrophy (DMD) in patients 4 years of age and older in England, Wales and Northern Ireland Santhera will be working closely with NHS England, NHS Wales and NHS Northern Ireland to ensure rapid patient access Santhera also pursuing reimbursement via the Scottish Medicines Consortium (SMC) to ensure...

Pratteln, Switzerland, October 1, 2024 – Santhera Pharmaceuticals (SIX: SANN) announces the positive outcome of the LIONHEART study, confirming vamorolone’s distinctive action also as a mineralocorticoid receptor antagonist, setting it apart from other corticosteroids. The LIONHEART study, an open-label randomized, placebo- and eplerenone-controlled study involving 30 healthy adult male subjects, met its primary endpoint. It demonstrated a statistically significant increase in the urinary...

Ad hoc announcement pursuant to Art. 53 LR A conference call will be held on September 12, 2024, 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 14.1 million (H1-2023: CHF 3.9 million) Operating result of CHF -17.7 million (H1-2023: CHF -20.3 million) and net result of CHF -15.3 million (H1-2023: CHF -23.3 million) AGAMREE® (vamorolone) launched in Germany and Austria as first European markets; North America...

Pratteln, Switzerland, September 10, 2024 – Santhera Pharmaceuticals (SIX: SANN) announces the signing of an exclusive distribution agreement with GENESIS Pharma for AGAMREE® (vamorolone) for the treatment of Duchenne muscular dystrophy (DMD) in 20 markets in Central and Eastern Europe. Santhera Pharmaceuticals and GENESIS Pharma have signed a distribution agreement for 20 markets in Central and Eastern Europe. This strategic collaboration aims to address unmet medical needs by allowing...

Pratteln, Switzerland, June 18, 2024 – 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 4,535,785 shares or 35.9% of the Company’s share capital. Approval of the 2023 Annual Report and discharge of corporate bodies The shareholders approved the Annual Report, the annual financial...

Ad hoc announcement pursuant to Art. 53 LR A conference call will be held on June 19, 2024, at 14:00 CEST / 13:00 BST / 08:00 EDT. Details are at the end of this news release. Funding underpins the advancement of AGAMREE® (vamorolone) roll-out and growth in Europe and the pursuit of further developmental initiatives Financing includes up to USD 38 million from R-Bridge, an affiliate of CBC Group, in exchange for a partial monetization of royalty payments received by Santhera in North America...

Ad hoc announcement pursuant to Art. 53 LR Pratteln, Switzerland, May 28, 2024 – Santhera Pharmaceuticals (SIX: SANN) announces the publication of its Annual Report 2023 with fully audited results for the year ended December 31, 2023. Santhera’s Annual Report 2023 provides comprehensive and detailed information on the Company, its strategy, business, financial performance, governance and compensation in 2023, and confirms the preliminary unaudited 2023 annual results which were published on...

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 Report Publication in May 2023 financial key figures: Revenue from contracts with customers of CHF 103.4 million (2022: CHF 7.5 million) Net result of CHF 54.8 million (2022: CHF -71.1 million) Cash flow from operating...

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, 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...

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 approved in both the U.S. and EU First 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...

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...

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 launch in Q1-2024 FDA 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 obligations Following the recent positive...

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 older European Commission (EC) decision on marketing authorization is expected in late 2023 AGAMREE 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...

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...

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] . T he proceeds from the agreement extend Santhera’s cash reach into 2025 . T ogether with the expected income from ongoing operations , it provides funding for the pre-commercialization and launch...

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 , 202 3 – Santhera Pharmaceuticals (SIX: SANN) announce s the timeline of the reverse share split in the ratio 10:1 which was approved by shareholders at the Annual General M eeting held on June 27, 2023 , with a large majority. June 30, 2023 : Last trading day of old shares (ISIN:...

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 bodies The shareholders approved the Annual Report, the annual...