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Upgrade Now Cboe UK • CHF Santhera Pharmaceuticals Holding AG (SANNZ.XC) Follow Compare 16.26 -0.32 (-1.93%) At close: February 28 at 4:19:12 PM GMT All News Press Releases SEC Filings All SEC Filings Corporate Changes & Voting Matters Periodic Financial Reports Proxy Statements Tender Offer/Acquisition Reports Offering Registrations Santhera Announces Agreement with German GKV-SV on Reimbursement Amount for AGAMREE® (vamorolone) for the Treatment of Duchenne Muscular Dystrophy in Germany Ad hoc announcement pursuant to Art. 53 LR AGAMREE® is the first product to receive an agreed federal price in Germany for the treatment of all DMD patients 4 years and older, and independent of genetic mutation Pratteln, Switzerland, February 13, 2025 – Santhera Pharmaceuticals (SIX: SANN), a specialty pharmaceutical company focused on rare diseases, today announces an agreement with the German National Association of Statutory Health Insurance Funds (GKV-SV) on the reimbursement for AGAMREE® ( Santhera Announces Chief Financial Officer Transition with Appointment of Catherine Isted Catherine Isted, an experienced healthcare CFO with over 25 years in life sciences, appointed as CFO effective February 24, 2025Current CFO Andrew Smith to step down after five years with Santhera, and will support an orderly transition Pratteln, Switzerland, February 10, 2025 – Santhera Pharmaceuticals (SIX: SANN) announces the appointment of Catherine Isted as Chief Financial Officer (CFO), effective February 24, 2025. She succeeds Andrew Smith, who, after five years at Santhera and financiall Santhera Pharmaceuticals Provides Update on Royalty Agreement for AGAMREE® (Vamorolone) and Warrants held by Idorsia Pratteln, 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. Idorsia transfers rights to royalties and milestones for AGAMREE (vamorolone) to R-Bridge Healthcare Santhera Receives Positive NICE Final Guidance for AGAMREE® (Vamorolone) as a Treatment for Duchenne Muscular Dystrophy 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 and ol 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 UKPratteln, Switzerland, January 14, 2025 – Santhera Pharmaceuticals (SIX: SANN) announces that the Scottish Medicines Consortium (SMC) has published recommendations that AGAMREE® (vamorolone) is accepted for use within NHS Scotland for the treatment of Duchenne muscular dystrophy (DMD) in patients 4 years of age and older.Dario Eklund, CEO of Santhera, commented: "I am delighted t Santhera Enters into Supply and Distribution Agreement for AGAMREE® (Vamorolone) with Clinigen Group 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 of Santhera Announces Approval in Hong Kong for AGAMREE® (Vamorolone) as a Treatment for Duchenne Muscular Dystrophy Department of Health (DoH) of Hong Kong approved AGAMREE® for the treatment of Duchenne muscular dystrophy (DMD) in patients aged 4 years and older Follows recent approval from China’s National Medical Products Administration (NMPA) Pratteln, 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. The approval by the DoH of Hong Kong constitute Santhera Announces Approval from China’s NMPA for AGAMREE® (Vamorolone) as a Treatment for Duchenne Muscular Dystrophy China’s National Medical Products Administration (NMPA) approved AGAMREE® for the treatment of Duchenne muscular dystrophy in patients aged 4 years and olderThis approval makes AGAMREE the first and only approved DMD therapy in China Pratteln, 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. "DMD is a devastating condi 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 IrelandSanthera 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 access for patients in ScotlandPratteln, Switzerland, December 10, 2024 – Santhera Pharmaceuticals (SIX: SANN) announces that the Na Santhera Enters into Exclusive Supply Agreement for AGAMREE® (Vamorolone) with Ali Al Suwaidi Trading Establishment (ASTE) in Qatar Pratteln, 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. The agreement enables ASTE, a pioneering healthcare distributor with over four decades of experience in Qatar, to address the high unmet need of DMD patients in the region. As the sole distributor of AGAMREE to Q Santhera Announces Positive Topline Results from LIONHEART Study with AGAMREE® (vamorolone) Demonstrating Unique Mineralocorticoid Receptor Antagonism 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 sodium Santhera Announces Acceptance by Swissmedic of Marketing Authorization Application for AGAMREE® (vamorolone) in Duchenne Muscular Dystrophy Pratteln, 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 asked Swissmedic to assess AGAMREE® as part of Article 13 TPA (therapeutics product act) procedure, allowing it to consider the results of foreign regulatory authorities’ assessments when Santhera Announces Half-Year 2024 Financial Results and Provides Corporate Update 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 partner h Santhera Enters into an Exclusive Distribution Agreement with GENESIS Pharma for AGAMREE® (Vamorolone) in Central and Eastern Europe 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 GENESIS Santhera Closes Financings and Secures Funds to Reach Break-Even Expected in 2026 Ad hoc announcement pursuant to Art. 53 LR Pratteln, Switzerland, August 13, 2024 – Santhera Pharmaceuticals (SIX: SANN) announces the closing of two financing agreements that provided the Company with gross funding totaling approximately CHF 69 million. Together with existing cash resources, this will support the Company's growth initiatives, repayment of maturing convertible bonds and liquidity through to the first half of 2026, at which point Santhera expects to be cash flow break-even. CHF 3 Santhera Appoints Dr. Oliver P. Kronenberg as Chief Legal Officer and Company Secretary Dr. Kronenberg brings 25 years of legal experience, with 20 years in the pharmaceutical industry Oliver Strub appointed as Head of Compliance Pratteln, 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. As a member of the executive management team, Dr. Oliver P. Kronenberg will lead the Company's legal stra Santhera’s Shareholders Approve all Board Proposals at Today’s Annual General Meeting 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 bodiesThe shareholders approved the Annual Report, the annual financial stateme Santhera Secures up to CHF 69 million in Royalty and Debt Financing to Fund Operations to Cash Flow Break-Even 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 and Santhera Announces Launch of Early Access Program in China for AGAMREE® by its Partner Sperogenix Pratteln, 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). In April 2024, the Hainan Medical Products Administration (HMPA) authorized the EAP for AGAMREE based on local policies, AGAMREE’s existing overseas approvals (U.S., EU, UK) and its demonstrated ability to address urgent clinical need Santhera Publishes Agenda for its Annual General Meeting Ad hoc announcement pursuant to Art. 53 LR Pratteln, Switzerland, May 28, 2024 – Santhera Pharmaceuticals (SIX: SANN) today published the invitation to its Annual General Meeting (AGM), which will be held on June 18, 2024, at 10:00 CEST at Haus der Wirtschaft, Hardstrasse 1, 4133 Pratteln, Switzerland. The invitation to the AGM with agenda items and explanations will be sent to registered shareholders by mail and can be viewed on Santhera’s website at https://www.santhera.com/share-bondholder-me Performance Overview Trailing total returns as of 2/28/2025, which may include dividends or other distributions. Benchmark is MSCI WORLD Return SANNZ.XC MSCI WORLD YTD +15.65% +2.32% 1-Year +47.95% +14.21% 3-Year -89.41% 0.00%