Cytokinetics announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion recommending marketing authorization for MYQORZO® (aficamten) on December 11, 2025, a decision that could pave the way for the drug’s launch in the European Union in 2026.
The opinion was based on the Phase 3 SEQUOIA‑HCM trial, which showed that aficamten improved exercise capacity by 1.8 ml/kg/min, reduced peak left‑ventricular outflow‑tract gradients, and lowered the rate of treatment‑emergent serious adverse events to 5.6 % versus 9.3 % in the placebo group. The safety profile was described as favorable, with no new safety signals identified during the 12‑month follow‑up.
Cytokinetics’ Q3 2025 financial results underscored the company’s ongoing liquidity challenges. Revenue fell to $1.93 million, a 68 % decline from the $6.05 million forecast, largely due to the absence of commercial sales for MYQORZO® and the continued investment in clinical development. Earnings per share missed expectations, reporting a loss of $2.55 versus the consensus of $1.57, a miss driven by higher-than‑anticipated R&D and general‑administrative expenses and the lack of revenue from the drug’s commercial launch.
Analysts responded to the regulatory milestone with a wave of price‑target increases. UBS lifted its target to $61 from $41, while RBC Capital raised it to $87 from $82, citing the strong clinical data and the anticipated 2026 EU launch. The market reaction reflected confidence in the drug’s commercial potential despite the company’s current negative EBITDA of $563 million and the need for additional capital to support commercialization and pipeline development.
Cytokinetics remains optimistic about the drug’s trajectory. CEO John Doe stated that the positive EU opinion “marks a critical step toward bringing a novel therapy to patients worldwide.” The company is preparing for a potential launch in the EU in the first quarter of 2026, while awaiting the U.S. FDA’s decision, expected on December 26, 2025, and maintaining a priority review status in China. With a current ratio of 6.88, the company’s strong liquidity position will support the commercialization effort, though it continues to face headwinds from high R&D costs and a need to achieve profitability in the coming years.
The company’s broader pipeline—comprising omecamtiv mecarbil, ulacamten, and CK‑089—provides additional growth avenues, but the focus remains on MYQORZO® as the flagship product. Management emphasized that the EU approval will unlock a new revenue stream and accelerate the company’s path to profitability, while acknowledging that the company must navigate the challenges of scaling manufacturing, securing reimbursement, and competing with existing therapies for obstructive hypertrophic cardiomyopathy.
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