- FDA & Global Approvals: MYCorzo approved in the US, China, and with CHMP positive opinion in the EU, marking 2025 as a pivotal year for Cytokinetics.
- Commercial Launch Momentum: Immediate US launch post-FDA approval, achieving 700+ REMS-certified HCPs in 3 weeks and 12,000+ customer engagements within the first quarter.
- Financial Performance: Ended 2025 with $1.22B cash, but Q4 net loss rose to $183M ($1.50/share) vs. $150M ($1.26/share) in 2024, driven by R&D ($416M) and G&A ($284.3M) expenses.
- ACACIA-HCM Trial Outlook: Pivotal Phase 3 results expected Q2 2026, targeting statistical significance on KCCQ or peak VO2 endpoints with 90% power and 10% discontinuation rate.
Commercial Launch of MYCorzo
The company has made significant progress in the commercial launch of MYCorzo, with over 700 healthcare professionals REMS-certified within three weeks of approval. According to Andrew M. Callos, EVP and Chief Commercial Officer, the company has achieved over 12,000 customer engagements and is seeing strong demand from cardiologists and patients. The company's early market uptake is in line with expectations, driven by demand from cardiologists and patients who were awaiting approval.
Pipeline Advancements
Cytokinetics is advancing its pipeline, with the ACACIA-HCM trial expected to report top-line results in Q2 2026. Fady Malik, EVP of R&D, noted that the study is designed to demonstrate a five-point delta on KCCQ and a peak VO2 of 1, with 90% power to detect statistically significant differences. The company is also conducting the COMMUN-HF and AMBER-HFpEF clinical trials, and is on track to share results from these trials in the coming quarters.
Financial Guidance
The company expects GAAP combined R&D and SG&A expenses to be between $830 million and $870 million in 2026, with stock-based compensation expected to be between $120 million and $130 million. Cytokinetics finished 2025 with approximately $1.22 billion in cash, cash equivalents, and investments, providing a strong foundation for the company's growth plans.
Valuation
With analysts estimating next year's revenue growth at 226.1%, the company's valuation multiples are worth examining. The P/S Ratio is 98.28, indicating a high valuation relative to sales. The EV/EBITDA ratio is -14.77, reflecting the company's negative earnings. As the company advances its pipeline and launches MYCorzo in new markets, investors will be watching for progress on revenue growth and profitability.