Santhera Pharmaceuticals has secured approximately CHF 20 million in additional growth funding from existing investors to accelerate the global expansion of AGAMREE (vamorolone), a novel treatment for Duchenne muscular dystrophy (DMD). The Swiss specialty pharmaceutical company announced the financing agreements with R-Bridge, an affiliate of CBC Group, and Highbridge Capital Management on September 23, 2025.
The funding comes as demand for AGAMREE continues to exceed expectations across key markets. Over 1,000 patients have been treated worldwide with the dissociative steroid, which offers an alternative to traditional corticosteroids for children and adolescents with DMD.
Strong Market Performance Drives Funding Need
In the United States, partner Catalyst Pharmaceuticals reported robust first-half 2025 performance with AGAMREE sales of USD 49.4 million, driven by accelerated physician adoption and sustained uptake. Meanwhile, in China, partner Sperogenix Therapeutics is experiencing increased demand expectations for 2025 and 2026 following their launch into the private-pay market. European demand has also remained strong.
"Demand for AGAMREE continues to exceed expectations across the US, Europe and China," said Dario Eklund, Chief Executive Officer of Santhera. "With this additional funding, we can accelerate launches, build inventory, and pursue our trajectory towards cashflow break-even in 2026."
Financing Structure Details
The CHF 20 million funding package consists of two components. R-Bridge will provide USD 13 million through a royalty monetization agreement, receiving 25% of net royalties on AGAMREE from Catalyst (North America) and Sperogenix (China). This arrangement adds to an existing agreement under which R-Bridge already receives 75% of net royalties from these licenses. Payments to R-Bridge are capped, and once the agreed ceiling or duration is met, royalties revert to Santhera, which retains buy-back rights over the royalty stream.
Highbridge Capital Management will contribute CHF 10 million via a new convertible note while exchanging the existing CHF 7 million convertible bond that was scheduled to mature on September 30, 2025. The new convertible bond carries a three-year maturity with a conversion price set at a 10% premium to the closing share price on the announcement date. Additionally, Santhera will issue Highbridge approximately 110,000 shares as consideration for increased flexibility regarding the CHF 35 million four-year term loan signed in August 2024.
Novel Mechanism of Action
AGAMREE represents a breakthrough in DMD treatment through its unique mechanism of action. The drug binds to the same receptor as glucocorticoids but modifies downstream activity, positioning it as a dissociative anti-inflammatory drug. Crucially, AGAMREE is not a substrate for 11-β-hydroxysteroid dehydrogenase (11β-HSD) enzymes that may be responsible for local drug amplification and corticosteroid-associated toxicity in tissues.
This mechanism has demonstrated the potential to separate efficacy from steroid safety concerns, offering an alternative to existing corticosteroids, which represent the current standard of care for children and adolescent patients with DMD.
Clinical Evidence and Safety Profile
In the pivotal VISION-DMD study, AGAMREE met the primary endpoint of Time to Stand (TTSTAND) velocity versus placebo (p=0.002) at 24 weeks of treatment while demonstrating a favorable safety and tolerability profile. The most commonly reported side effects included cushingoid features, vomiting, weight increase, and irritability, with side effects generally of mild to moderate severity.
Importantly, currently available data show that AGAMREE, unlike traditional corticosteroids, has no restriction of growth and no negative effects on bone metabolism, as demonstrated by normal bone formation and bone resorption serum markers.
Global Regulatory Approvals
AGAMREE has received regulatory approval for DMD treatment across multiple jurisdictions, including the United States (FDA), European Union (European Commission), United Kingdom (MHRA), China (NMPA), and Hong Kong (Department of Health). Santhera has strategically out-licensed rights to AGAMREE for North America to Catalyst Pharmaceuticals and for China and certain Southeast Asian countries to Sperogenix Therapeutics.
The additional funding will enable Santhera to meet growing global demand, particularly supporting plans to increase inventory in China and accelerate launch timelines across international markets as the company progresses toward its 2026 cashflow break-even target.
