Santhera Pharmaceuticals Holding AG
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- Santhera Pharmaceuticals Holding AG is a Swiss specialty pharmaceutical company focused on the research, development, and commercialization of innovative medicines for rare neuromuscular and pulmonary diseases with high unmet medical needs, primarily targeting Duchenne muscular dystrophy (DMD) and cystic fibrosis (CF). Its core products include AGAMREE® (vamorolone), a corticosteroid replacement therapy for DMD, Lonodelestat for neutrophilic pulmonary diseases including CF, and ongoing development of gene therapy for LAMA2-deficient congenital muscular dystrophy. The company operates globally with commercial activities and partnerships across Europe, North America, and Asia, supported by subsidiaries in Switzerland, the USA, Canada, Germany, and Finland. Founded in 2004 and headquartered in Pratteln, Switzerland, Santhera recently achieved significant commercial milestones including the European launch of AGAMREE in Germany, Austria, UK, and expansion into 20 Central and Eastern European countries, Israel, Qatar, Gulf Cooperation Council countries, Türkiye, India, and China through partnerships and direct market sales. In 2024–2025, Santhera strengthened its financial position with a 70% revenue growth driven by AGAMREE sales, secured reimbursement agreements in key markets such as Germany and the UK, expanded manufacturing capacity with partner Catalyst to improve supply chain robustness, and transitioned CFO leadership with Catherine Isted appointed in 2025. The company continues to invest in expanding AGAMREE’s market reach and pipeline development while focusing on maximizing value from its DMD franchise, with preparations underway for publication of the GUARDIAN study results on long-term treatment outcomes expected in Q4 2025.
Company News
Santhera’s Licensing Partner, Nxera Pharma, Submits Marketing Authorization Application for AGAMREE® (Vamorolone) in South Korea
Santheras Lizenzpartner Nxera Pharma reicht in Südkorea einen Antrag auf Marktzulassung für AGAMREE® (Vamorolon) ein
Santhera Notes Topline Results from Catalyst Pharmaceuticals’ Phase 1 Clinical Study of AGAMREE®
Santhera gibt Topline-Ergebnisse der klinischen Phase-1-Studie von Catalyst Pharmaceuticals zu AGAMREE® bekannt
Santhera gibt die Erteilung des Orphan-Drug-Status und der Prioritätsprüfung für AGAMREE® (Vamorolon) in Südkorea bekannt
Santhera Announces Orphan Drug and Priority Review Designations for AGAMREE® (Vamorolone) in South Korea
Santhera’s Shareholders Approve all Board Proposals at Today’s Annual General Meeting
Santheras Aktionäre stimmen auf der heutigen Hauptversammlung allen Anträgen des Verwaltungsrats zu
Santhera Proposes Dr. Srishti Gupta as New Member of the Board of Directors
Santhera schlägt Dr. Srishti Gupta als neues Mitglied des Verwaltungsrats
eBay heads into Q1 earnings with momentum, but macro clouds loom
Santhera Receives Positive CHMP Opinion to Expand AGAMREE® (vamorolone) Use in Pediatric DMD Patients Aged Two and Older in the EU
Santhera erhält positive Stellungnahme des CHMP zur Ausweitung der Anwendung von AGAMREE® (Vamorolon) bei pädiatrischen DMD-Patienten ab zwei Jahren in der EU
Santhera ernennt Orlando Oliveira zum Chief Executive Officer
Santhera Appoints Orlando Oliveira as Chief Executive Officer
Full Year 2025 Trading Update
Handelsupdate für das Geschäftsjahr 2025
Santhera Appoints Marc Clausse as Chief Commercial Officer to Lead Next Phase of Growth
Santhera ernennt Marc Clausse zum Chief Commercial Officer, um die nächste Wachstumsphase voranzutreiben
AGAMREE® (vamorolone) Data Presented at MDA 2026 Confirm Comparable Long-Term Effectiveness for up to 8 Years of Treatment, with Clinically Meaningful Safety Advantages in Duchenne Muscular Dystrophy