Core Viewpoint - Cytokinetics and Royalty Pharma have entered into a strategic funding collaboration to support the commercialization of aficamten and advance Cytokinetics' cardiovascular pipeline, providing up to $575 million in total funding [1][2][5] Group 1: Funding Details - Cytokinetics will receive $50 million upfront for a Phase 2 clinical trial of CK-586, with Royalty Pharma having the option to invest an additional $150 million for Phase 3 development [3] - The collaboration includes $50 million for the commercial launch of aficamten, with an additional $175 million available within 12 months of FDA approval, repayable over 10 years [4] - Royalty Pharma's royalty on aficamten has been restructured to 4.5% on annual net sales up to $5 billion and 1% above that threshold [4] Group 2: Clinical Development - Aficamten has shown a positive clinical profile in its pivotal Phase 3 study and is expected to improve the lives of patients with hypertrophic cardiomyopathy (HCM) if approved by the FDA [2][9] - Cytokinetics plans to submit a New Drug Application (NDA) for aficamten in Q3 2024 and a Marketing Authorization Application (MAA) in Q4 2024 [9] - The company is also advancing CK-586 to a Phase 2 trial for heart failure with preserved ejection fraction (HFpEF), expected to begin in Q4 2024 [14] Group 3: Company Background - Cytokinetics is a late-stage biopharmaceutical company focused on developing muscle activators and inhibitors for cardiac diseases [15] - The company is preparing for regulatory submissions for aficamten and is also developing omecamtiv mecarbil and CK-586 for various heart failure indications [15] - Royalty Pharma is a leading funder of biopharmaceutical innovation, collaborating with various companies to support late-stage clinical trials and new product launches [17]
Cytokinetics and Royalty Pharma Announce Expanded Strategic Funding Collaboration Totaling Up to $575 Million to Support Commercial Launch of Aficamten and to Advance R&D Pipeline