Santhera Pharmaceuticals Provides Update on Royalty Agreement for AGAMREE® (Vamorolone) and Warrants held by IdorsiaPratteln, Switzerland, January 16, 2025 – Santhera Pharmaceuticals (SIX: SANN) announces that Idorsia Pharmaceuticals has entered into a royalty monetization agreement with the R-Bridge Healthcare Fund in relation to AGAMREE® (vamorolone). Idorsia has also recently exercised outstanding warrants held in Santhera on a cashless basis, reinforcing its position as a major shareholder in the Company.
Santhera Receives Positive NICE Final Guidance for AGAMREE® (Vamorolone) as a Treatment for Duchenne Muscular DystrophyPratteln, 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 and older.
Santhera Receives Positive Recommendation from Scottish Medicines Consortium for the Use of AGAMREE® (Vamorolone) in Duchenne Muscular Dystrophy Patients in NHS ScotlandSanthera Receives Positive Recommendation from Scottish Medicines Consortium for the Use of AGAMREE® (Vamorolone) in Duchenne Muscular Dystrophy Patients in NHS Scotland
Santhera Enters into Supply and Distribution Agreement for AGAMREE® (Vamorolone) with Clinigen GroupPratteln, 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 Announces Approval in Hong Kong for AGAMREE® (Vamorolone) as a Treatment for Duchenne Muscular DystrophyPratteln, Switzerland, December 20, 2024 – Santhera Pharmaceuticals (SIX: SANN) announces that the Department of Health of Hong Kong, China, has approved AGAMREE® (vamorolone) for use in patients aged 4 years and older.
Santhera Announces Approval from China’s NMPA for AGAMREE® (Vamorolone) as a Treatment for Duchenne Muscular DystrophyPratteln, Switzerland, December 11, 2024 – Santhera Pharmaceuticals (SIX: SANN) announces that China’s National Medical Products Administration (NMPA) has approved AGAMREE® (vamorolone) for use in China in patients aged 4 years and older.
Santhera Receives Positive Recommendation from NICE for AGAMREE® (Vamorolone) as a Treatment for Duchenne Muscular DystrophySanthera Receives Positive Recommendation from NICE for AGAMREE® (Vamorolone) as a Treatment for Duchenne Muscular Dystrophy
Santhera Enters into Exclusive Supply Agreement for AGAMREE® (Vamorolone) with Ali Al Suwaidi Trading Establishment (ASTE) in QatarPratteln, Switzerland, November 12, 2024 – Santhera Pharmaceuticals (SIX: SANN) announces the signing of an exclusive supply agreement with Ali Al Suwaidi Trading Est. (ASTE) for the treatment of patients with Duchenne muscular dystrophy (DMD) with AGAMREE under a Named Patient Program.
Santhera Announces Positive Topline Results from LIONHEART Study with AGAMREE® (vamorolone) Demonstrating Unique Mineralocorticoid Receptor AntagonismPratteln, 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.
Santhera Announces Acceptance by Swissmedic of Marketing Authorization Application for AGAMREE® (vamorolone) in Duchenne Muscular DystrophyPratteln, Switzerland, September 24, 2024 – Santhera Pharmaceuticals (SIX: SANN) announces that Swissmedic, the Swiss Agency for Therapeutic Products, has accepted for review the marketing authorization application (MAA) for AGAMREE® (vamorolone) for the treatment of Duchenne muscular dystrophy (DMD).
Santhera Enters into an Exclusive Distribution Agreement with GENESIS Pharma for AGAMREE® (Vamorolone) in Central and Eastern EuropePratteln, 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 Appoints Dr. Oliver P. Kronenberg as Chief Legal Officer and Company SecretaryPratteln, Switzerland, July 31, 2024 – Santhera Pharmaceuticals (SIX: SANN) announces the Board of Directors has appointed Dr. Oliver P. Kronenberg as Chief Legal Officer and Corporate Secretary of Santhera Pharmaceuticals AG, effective August 1, 2024.
Santhera’s Shareholders Approve all Board Proposals at Today’s Annual General MeetingPratteln, 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.
Santhera Announces Launch of Early Access Program in China for AGAMREE® by its Partner SperogenixPratteln, Switzerland, June 10, 2024 – Santhera Pharmaceuticals (SIX: SANN) announces that its partner Sperogenix Therapeutics has launched a paid-for Early Access Program (EAP) for AGAMREE® (vamorolone) in China for patients with Duchenne muscular dystrophy (DMD).
Santhera Publishes Annual Report 2023Ad hoc announcement pursuant to Art. 53 LR
Santhera Announces NDA for Vamorolone in Duchenne Muscular Dystrophy Accepted and Granted Priority Review by China’s NMPAPratteln, 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.
Santhera’s Partner Catalyst Pharmaceuticals Launches AGAMREE® (Vamorolone) in the United StatesPratteln, Switzerland, March 14, 2024 – Santhera Pharmaceuticals (SIX: SANN) is pleased to note the launch of AGAMREE® (vamorolone) for the treatment of Duchenne muscular dystrophy (DMD) in the United States (U.S.) by Catalyst Pharmaceuticals, Inc. (
NASDAQCPRX), the Company’s commercialization partner for North America.
Santhera Announces Publication of Efficacy, Safety and Tolerability Data with Vamorolone (AGAMREE®) in Patients with Duchenne Muscular Dystrophy in NeurologyPratteln, Switzerland, February 14, 2024 – Santhera Pharmaceuticals (SIX: SANN) 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 [2]. The publication reports the results of the 48-week treatment with vamorolone in patients with DMD in the VISION-DMD study, supporting the long-term efficacy and safety profile of vamorolone and concluding that vamorolone was generally well tolerated, consistent with the 24-week study findings, as published previously in JAMA Neurology [3].
Santhera Launches AGAMREE® (Vamorolone) in Germany as First Market for the Treatment of Duchenne Muscular DystrophyPratteln, 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 mutation and ambulatory status, in Germany.
Santhera Receives Approval for AGAMREE® (Vamorolone) as a Treatment for Duchenne Muscular Dystrophy in the United KingdomPratteln, Switzerland, January 12, 2024 – Santhera Pharmaceuticals (SIX: SANN) announces that AGAMREE® (vamorolone) has been approved in the United Kingdom (UK) for the treatment of Duchenne muscular dystrophy (DMD) in patients 4 years of age and older, independent of the underlying mutation and ambulatory status. The UK’s MHRA, adopting the view of the European Medicines Agency (EMA), acknowledged clinically important safety benefits of AGAMREE with regards to maintaining normal bone metabolism, density and growth compared to standard of care corticosteroids, alongside similar efficacy [1].
Santhera’s AGAMREE® (Vamorolone) Approved in the European Union for the Treatment of Duchenne Muscular DystrophyPratteln, Switzerland, December 18, 2023 – Santhera Pharmaceuticals (SIX: SANN) announces that AGAMREE® (vamorolone) has been approved in the European Union (EU) for the treatment of Duchenne muscular dystrophy (DMD) in patients 4 years of age and older, independent of the underlying mutation and ambulatory status. The European Medicines Agency (EMA) acknowledged clinically important safety benefits of AGAMREE with regards to maintaining normal bone metabolism, density and growth compared to standard of care corticosteroids, alongside similar efficacy [1]. In addition, patients who switched from a standard of care corticosteroid to AGAMREE maintained the efficacy benefit while recovering their growth and bone health.
Santhera Appoints Executive Committee Members as it Transitions into Commercial StagePratteln, 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 Publishes Timeline of the Reverse Share SplitNOT FOR RELEASE, PUBLICATION OR DISTRIBUTION IN THE UNITED STATES OR ANY OTHER JURISDICTION IN WHICH IT WOULD BE UNLAWFUL TO DO SO.
Shareholders Approve all Board Proposals at Today’s Annual General MeetingPratteln, 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.
Santhera Publishes Agenda for its Annual General MeetingNOT FOR RELEASE, PUBLICATION OR DISTRIBUTION IN THE UNITED STATES OR ANY OTHER JURISDICTION IN WHICH IT WOULD BE UNLAWFUL TO DO SO.
Santhera Publishes Annual Report 2022Ad hoc announcement pursuant to Art. 53 LR
Vamorolone NDA mid-cycle review meeting by FDA completedPratteln, 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).
Santhera Submits Marketing Authorization Application to the UK MHRA for Vamorolone in Duchenne Muscular DystrophyPratteln, Switzerland, March 2, 2023 – Santhera Pharmaceuticals (SIX: SANN) announces that it has submitted a marketing authorization application (MAA) to the UK Medicines and Healthcare products Regulatory Agency (MHRA) for vamorolone for the treatment of Duchenne muscular dystrophy (DMD).
Santhera Secures Additional Funding Through a Private Placement of Shares and Upsizing of Existing Financing ArrangementNOT FOR RELEASE, PUBLICATION OR DISTRIBUTION IN THE UNITED STATES OR ANY OTHER JURISDICTION IN WHICH IT WOULD BE UNLAWFUL TO DO SO.
Santhera’s Shareholders Approve all Board Proposals at Today’s Extraordinary General MeetingPratteln, Switzerland, November 29, 2022 – Santhera Pharmaceuticals (SIX: SANN) announces that its shareholders have approved all proposals by the Board of Directors at the Extraordinary General Meeting (EGM) held today at the Company’s domicile in Pratteln, Switzerland. In total, 18,776,400 shares equaling 25.5% of the Company’s share capital were represented.
European Medicines Agency Validates Santhera’s Marketing Authorization Application for Vamorolone in Duchenne Muscular DystrophyPratteln, Switzerland, October 31, 2022 – Santhera Pharmaceuticals (SIX: SANN) announces that the European Medicines Agency (EMA) has validated its marketing authorization application (MAA) for vamorolone for the treatment of Duchenne muscular dystrophy (DMD). Validation confirms that the submission is complete and that the review by the EMA’s Committee for Medicinal Products for Human Use (CHMP) has begun.
Santhera and ReveraGen Announce Presentations on Long-Term Efficacy and Bone Health in DMD During Vamorolone Treatment at the 2022 World Muscle Society CongressPratteln, Switzerland, and Rockville, MD, USA, October 10, 2022 – Santhera Pharmaceuticals (SIX: SANN) and ReveraGen BioPharma, Inc announce presentations of data relating to long-term efficacy, tolerability and the impact of vamorolone on bone health in patients with Duchenne muscular dystrophy (DMD) over 2.5 years of treatment [1].
Santhera Submits Marketing Authorization Application to the European Medicines Agency for Vamorolone in Duchenne Muscular DystrophyPratteln, Switzerland, October 3, 2022 – Santhera Pharmaceuticals (SIX: SANN) announces that the Company has submitted a marketing authorization application (MAA) to the European Medicines Agency (EMA) for vamorolone for the treatment of Duchenne muscular dystrophy (DMD).
