Cytokinetics Wins EU Approval for Myqorzo, Yet Execution Hurdles and Financial Risks Loom Large

What happened

Cytokinetics has secured EU approval for Myqorzo in symptomatic obstructive HCM, expanding its first commercial drug into a major global market through partners like Sanofi and Bayer. This milestone follows U.S. and China approvals but launches against Bristol Myers' entrenched Camzyos, which already treated over 12,500 U.S. patients by mid-2025 with strong guideline support. Myqorzo's once-touted REMS and monitoring advantage has eroded after Camzyos' 2025 label simplification, making rapid market share gains ambitious for a company with no proven commercial track record. The approval does not change the critical near-term catalyst: ACACIA nHCM Phase 3 data in Q2 2026, which will validate or undermine Myqorzo's expansion into non-obstructive HCM. With a leveraged balance sheet, negative equity, and persistent cash burn, Cytokinetics' ~$7.7B valuation remains highly dependent on flawless execution and positive clinical outcomes, leaving little room for error.

Implication

The EU approval provides incremental revenue potential through ex-U.S. partners, yet investors must focus on the U.S. launch, where early 2026 sales metrics will reveal if Myqorzo can meaningfully compete against Camzyos in a crowded market. Upcoming ACACIA nHCM data in Q2 2026 represents a binary event; failure would collapse the cardiomyopathy platform narrative and likely trigger significant downside given the stock's aggressive valuation. Cytokinetics' complex capital structure, including royalty obligations and negative equity, offers minimal margin of safety, making any commercial underperformance a catalyst for dilution or recapitalization. Market sentiment remains overly bullish with crowded positioning, increasing vulnerability to disappointment from launch hiccups or clinical setbacks. Given the 'POTENTIAL SELL' rating and skewed risk-reward, investors should avoid new positions and consider trimming exposure until evidence confirms above-consensus traction.

Thesis delta

The EU approval was anticipated following a positive CHMP opinion and does not shift the core investment thesis; it merely confirms a planned milestone in Myqorzo's global rollout. The thesis remains unchanged: valuation hinges on unproven U.S. launch execution against Camzyos and positive ACACIA nHCM data, with downside risks amplified by financial leverage and crowded bullish positioning.