Progress Towards FDA Approval of Aficamten
Cytokinetics made significant progress in preparing for the potential FDA approval of aficamten for patients with oHCM, with constructive engagements with the FDA and completion of key commercial launch readiness activities.
MAPLE-HCM Trial Success
The MAPLE-HCM trial demonstrated the superiority of aficamten over metoprolol in patients with oHCM, showing significant improvements in exercise capacity and challenging the use of beta blockers as the standard-of-care therapy.
Strong Financial Position
Cytokinetics has a strong balance sheet with approximately $1.25 billion in cash and investments, bolstered by a convertible note offering that provides additional capital and financial flexibility.
European and Global Expansion Plans
Preparations for potential commercial launch of aficamten in the EU and coordination with Sanofi for potential approval in China are well underway, with expected EMA approval in the first half of 2026.