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Significant transformation in 2025 included positive Phase 3 results for apitegromab in SMA, a BLA filing, and leadership changes. Regulatory delays due to manufacturing issues shifted the anticipated U.S. launch to 2026, allowing more time for commercial preparation and global expansion.
Significant transformation in 2025 included positive Phase 3 results for Apitegromab in SMA, a BLA filing, and leadership changes. Regulatory delays due to manufacturing issues shifted the expected U.S. launch to 2026, allowing more time for commercial readiness and payer engagement.
Apitegromab is poised to become the first muscle-targeted therapy for SMA, with strong phase III data supporting its use alongside existing SMN therapies. Regulatory approval is delayed due to manufacturing issues, but launch is expected in 2026, supported by a robust financial position and plans for global expansion.
A world-class leadership team is driving global expansion, with apitegromab positioned as the first muscle-targeted SMA therapy. Regulatory approval is delayed due to manufacturing issues, but financial resources are strong, and a 2026 U.S. launch is targeted.
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