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Cytokinetics (CYTK) FDA Events

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FDA Events for Cytokinetics (CYTK)

This section highlights FDA-related milestones and regulatory updates for drugs developed by Cytokinetics (CYTK). Over the past two years, Cytokinetics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as Aficamten, CK-4021586, CK-586, and omecamtiv. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

Cytokinetics' Drugs in FDA Review

Aficamten - FDA Regulatory Timeline and Events

Aficamten is a drug developed by Cytokinetics for the following indication: Symptomatic obstructive hypertrophic cardiomyopathy (oHCM). This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

CK-4021586 - FDA Regulatory Timeline and Events

CK-4021586 is a drug developed by Cytokinetics for the following indication: Novel, selective, oral, small molecule cardiac myosin inhibitor. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

CK-586 - FDA Regulatory Timeline and Events

CK-586 is a drug developed by Cytokinetics for the following indication: In Patients With Symptomatic Heart Failure With Preserved Ejection Fraction. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

omecamtiv mecarbil - FDA Regulatory Timeline and Events

omecamtiv mecarbil is a drug developed by Cytokinetics for the following indication: Novel cardiac muscle activator, patients with heart failure. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

Cytokinetics FDA Events - Frequently Asked Questions

However, the company does has had drugs under review or in active clinical development.

In the past two years, Cytokinetics (CYTK) has reported FDA regulatory activity for the following drugs: Aficamten, CK-4021586, CK-586 and omecamtiv mecarbil.

The most recent FDA-related event for Cytokinetics occurred on May 18, 2025, involving Aficamten. The update was categorized as "Data Presentation," with the company reporting: "Cytokinetics, Incorporated announced that additional data arising from two analyses from SEQUOIA-HCM, (Safety, Efficacy, and Quantitative Understanding of Obstruction Impact of Aficamten in HCM), the pivotal Phase 3 clinical trial of aficamten in patients with symptomatic obstructive hypertrophic cardiomyopathy (HCM), and results from a real-world analysis related to non-obstructive HCM were presented at the European Society of Cardiology Heart Failure 2025 Congress."

Current therapies from Cytokinetics in review with the FDA target conditions such as:

  • Symptomatic obstructive hypertrophic cardiomyopathy (oHCM) - Aficamten
  • Novel, selective, oral, small molecule cardiac myosin inhibitor - CK-4021586
  • In Patients With Symptomatic Heart Failure With Preserved Ejection Fraction - CK-586
  • Novel cardiac muscle activator, patients with heart failure - omecamtiv mecarbil

More FDA Event Resources from MarketBeat

  • NDA: New Drug Application
  • ANDA: Abbreviated New Drug Application
  • sNDA: Supplemental New Drug Application
  • BLA: Biologics License Application
  • sBLA: Supplemental Biologics License Application
  • FDA Approved: Approved by the FDA
  • EMA: European Medicines Agency
  • CE Mark: European Union Certification
  • NMPA: China National Medical Products Administration
  • MHLW: Japanese Ministry of Health
  • FDA Meeting: Consultation with FDA
  • Pre-IND: Pre-Investigational New Drug Meeting
  • Breakthrough Therapy: Special FDA designation for promising therapies
  • Fast Track: Accelerated FDA approval pathway
  • Orphan Drug: Designation for rare disease treatments
  • RPD: Rare Pediatric Disease Designation
  • RMAT: Regenerative Medicine Advanced Therapy
  • DSMB Review: Data Safety Monitoring Board Review
  • IDMC Review: Independent Data Monitoring Committee
  • MAA: MHRA Marketing Authorization Application
  • RTF: Refusal to File (Rejected Application)
  • 510(k): FDA Clearance for Medical Devices
  • Rolling Submission: Staggered regulatory review process

This page (NASDAQ:CYTK) was last updated on 7/10/2025 by MarketBeat.com Staff
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