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Cytokinetics reports $44.5M MYQORZO sales and sets non-obstructive HCM filings for Q4 and early 2027

🇺🇸 Cytokinetics Inc (CYTK) · Wed 04 Nov 2026

The company posted a $190.1M third-quarter net loss and says it will file for aficamten in non-obstructive HCM in the US this quarter and in the EU in early 2027.

Cytokinetics reported third-quarter 2026 results on 4 November, with net product revenue of $44.5 million from MYQORZO (aficamten), its treatment for obstructive hypertrophic cardiomyopathy (HCM). The company recorded a net loss of $190.1 million for the quarter.

The firm plans to submit a supplemental New Drug Application (sNDA) to the US regulator in the fourth quarter of 2026, seeking to extend aficamten to non-obstructive HCM. An EU Type II Variation, the usual route for changing an authorised product's indication, is scheduled for early 2027. Cytokinetics links both filings to positive Phase 3 results from the ACACIA-HCM trial.

Cytokinetics also pointed to progress outside the US. It noted authorisations from Health Canada and the UK Medicines and Healthcare products Regulatory Agency (MHRA), and guidance from NICE recommending aficamten in England and Wales. The company said it held about $1.6 billion in cash.

The summary available does not include detailed trial data, the proposed wording of the new indication or review timelines, so it is too early to say how regulators may handle the applications.

What it means for your team

  • Regulatory teams should note the planned US sNDA in Q4 2026 and the EU Type II Variation in early 2027 for non-obstructive HCM, which would widen the aficamten label if approved.
  • Market-access teams in England and Wales can point to NICE guidance recommending aficamten, while Canadian and UK authorisations mark a broader international footprint.
  • Pharmacovigilance and medical teams should expect a larger treated population if the indication expands, though the company's summary gives no new safety information.

Company's press release (SEC filing): Cytokinetics Inc ↗

Article written by VigiEye from the official source (Cytokinetics Inc). Claims are the company's own. AI-assisted; check the source before acting.

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