Pratteln, Switzerland, November 5, 2025 – Santhera Pharmaceuticals (SIX: SANN) announces the closing of a USD 13 million royalty monetization agreement, first announced in September 2025, to support the global launches of AGAMREE® (vamorolone). The agreement was initially secured in September 2025 with R-Bridge, an affiliate of CBC Group, covering 25% of net royalties on AGAMREE from Catalyst Pharmaceuticals, Inc. in North America and Sperogenix Therapeutics Ltd in China. Since initially securing the agree ...

Comparable long-term effectiveness to standard of care corticosteroids over 5 years Normal growth maintained, in contrast to growth suppression commonly seen with standard of care corticosteroids Significantly lower rate of vertebral fractures reported with AGAMREE Lower incidence of cataracts than normally seen for DMD patients on corticosteroids Pratteln, Switzerland, November 4, 2025 – Santhera Pharmaceuticals (SIX: SANN) today reported positive topline results from an analysis of long-term data, includ ...

Pratteln, Switzerland, October 9, 2025 – Santhera Pharmaceuticals (SIX: SANN) announces the signing of an exclusive agreement with Biomedica for the distribution of AGAMREE® (vamorolone) in Russia, for the treatment of Duchenne muscular dystrophy (DMD) in patients four years of age and older. Under the terms of the agreement, Santhera will receive a percentage of net sales, in line with previous distribution agreements, with sales expected to begin in Q1 2026. This collaboration will enable access to AGAMRE ...

Health Canada approved AGAMREE for the treatment of Duchenne muscular dystrophy in patients aged 4 years and olderThis approval makes AGAMREE the first and only approved therapy for DMD in Canada Pratteln, Switzerland, October 3, 2025 – Santhera Pharmaceuticals (SIX: SANN) today notes that Health Canada has approved AGAMREE® (vamorolone) for the treatment of Duchenne muscular dystrophy (DMD) in patients aged 4 years and older following Priority Review, marking the first approved treatment for the disease in ...

Ad hoc announcement pursuant to Art. 53 LR Pratteln, Switzerland, September 25, 2025 – Santhera Pharmaceuticals (SIX: SANN) today provides the following update regarding its convertible bond announced on 23 September 2025: Details: The conversion price has been set at CHF 13.5446, representing a 10% premium to the volume-weighted average price (VWAP) of Santhera’s shares on 23 September 2025. The coupon is 7%, reflecting a reduction compared with the previous bond.The aggregate principal amount of the conve ...

Ad hoc announcement pursuant to Art. 53 LR A conference call will be held on September 23, 2025, at 14:00 CEST / 13:00 BST / 08:00 BST. Details are at the end of this news release Pratteln, Switzerland, September 23, 2025 – Santhera Pharmaceuticals (SIX: SANN) announces the Company’s financial results for the six months ended June 30, 2025, reports on progress with AGAMREE® (vamorolone) for the treatment of Duchenne muscular dystrophy (DMD) and provides updates on its corporate and financing initiatives. Hi ...

Ad hoc announcement pursuant to Art. 53 LR Highlights: Santhera secures approximately CHF 20 million of additional funding from existing investors Highbridge and R-Bridge to accelerate global rolloutDemand for AGAMREE® (vamorolone) in US/China ahead of plan; increased inventory needs and launch timing shifts drive need for incremental growth capital Pratteln, Switzerland, September 23, 2025 – Santhera Pharmaceuticals (SIX: SANN) today announces new financing agreements with R-Bridge, an affiliate of CBC Gro ...

Pratteln, Switzerland, 29 August, 2025 – Santhera Pharmaceuticals (SIX: SANN) announces the signing of an exclusive agreement with Ikris Pharma Network (Ikris) to manage the distribution of AGAMREE® (vamorolone) in India, for the treatment of Duchenne muscular dystrophy (DMD) in patients four years of age and older. The agreement between Santhera and Ikris has a 5-year term and Santhera will receive a percentage of net sales, in line with previous distribution agreements. Sales are expected to begin in Q4 2 ...

核心观点 - 公司宣布与Uniphar签署独家分销协议 在中东五国分销AGAMREE® (vamorolone) 用于治疗4岁及以上杜氏肌营养不良症(DMD)患者[1] - 预计2026年第一季度开始以指定患者为基础销售 2026年底在获得市场授权和定价协议后扩大商业销售[1] - 公司将获得净销售额的分成付款 与既往分销协议一致[1] 协议细节 - 分销地区包括阿联酋、沙特阿拉伯、科威特、阿曼和巴林等海湾合作委员会(GCC)国家[1][2] - 合作基于Uniphar在早期和扩大准入项目方面的专业能力及区域影响力[2][3] - 协议是公司全球扩张战略的重要步骤 旨在为罕见病患者提供创新疗法[2] 产品特性 - AGAMREE®是一种新型解离性抗炎药 通过结合糖皮质激素受体但改变下游活性发挥作用[3] - 与标准皮质类固醇相比 该药物在关键VISION-DMD研究中达到主要终点(TTSTAND速度p=0.002)并显示良好安全性[4] - 现有数据表明该药物无生长限制作用 对骨代谢无负面影响[5] 商业布局 - AGAMREE®已在美国、欧盟、英国、中国和香港获得监管批准[8] - 公司已将北美权利授权给Catalyst Pharmaceuticals 将中国及部分东南亚国家权利授权给Sperogenix Therapeutics[8] - Uniphar是一家拥有57年经验的跨国医药服务商 业务覆盖180个国家 为200多家客户提供全生命周期服务[10][11] 合作方背景 - Uniphar总部位于爱尔兰都柏林 在欧洲、北美、亚太和中东地区具有强大影响力[11] - 公司专注于改善患者药物可及性 提供从市场准入、医学事务到商业化、物流的端到端解决方案[11][12]

债务融资安排 - 公司与Highbridge Capital Management LLC共同协议将700万瑞士法郎私人可转换债券到期日延长至2025年9月30日 该债券行权价为10.00瑞士法郎 [1] 核心产品与业务 - 公司专注于罕见神经肌肉疾病创新药物的开发与商业化 主要针对未满足医疗需求高的领域 [2] - 持有AGAMREE®（vamorolone）全球所有适应症的独家授权 该药物为具有新型作用机制的分离式类固醇 [2] - AGAMREE®在美国获FDA批准 在欧盟获EMA批准 在英国获MHRA批准 在中国获NMPA批准 在香港获DoH批准 用于杜氏肌营养不良症治疗 [2] 商业授权合作 - 将AGAMREE®北美权利授权给Catalyst Pharmaceuticals [2] - 将中国及部分东南亚国家权利授权给Sperogenix Therapeutics [2] 企业标识与联络 - AGAMREE®是公司注册商标 [3] - 公司首席财务官为Catherine Isted [3]