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CYTK
CYTOKINETICS INC
Cytokinetics develops small-molecule drugs that modulate muscle function to treat heart and skeletal muscle diseases. The company is advancing candidates like aficamten for hypertrophic cardiomyopathy and other cardiac conditions, along with programs in heart failure with preserved ejection fraction, with some programs in clinical testing and others in earlier development stages.
$63.97+49.32%1Y
CYTK · daily close · illustrative · 0 catalysts marked
Pipeline
Phase 2/3Pediatric
Phase 2/3Symptomatic Obstructive Hypertrophic Cardiomyopathy
Phase 3Symptomatic Non-Obstructive Hypertrophic Cardiomyopathy
Phase 2Symptomatic Heart Failure With Preserved Ejection Fraction (HFpEF)
UnknownIndication pending review
UnknownIndication pending review
Catalyst Calendar
JAN–JAN
Enroll.omecamtiv mecarbil
“If the Phase 3 clinical trial of omecamtiv mecarbil has not been initiated by June 30, 2026”
JAN–JAN
Readoutomecamtiv mecarbil
“If the Phase 3 clinical trial of Cytokinetics' proprietary small molecule cardiac myosin activator known as omecamtiv mecarbil is successful (defined as meeting the composite primary endpoint of the first event, whichever occurs first, comprising of cardiovascular death, heart failure event, LVAD implementation/cardiac transplantation, or stroke, with a hazard ratio (HR) of less than 0.85 and cardiovascular death endpoint HR of less than 1.0) by June 30, 2028”
2029
NDAomecamtiv mecarbil
“we receive the marketing approval from the U.S. Food and Drug Administration ("FDA") for omecamtiv mecarbil on or prior to December 31, 2029 ("OM Approval Date")”
Past (7)
MAY 08
ReadoutCK-4021586 (CK-586)
“On May 8, 2024, Cytokinetics, Incorporated (the "Company") announced topline data from the Phase 1 study of CK-4021586 (CK-586).”
MAY 08
Enroll.Aficamten
“CEDAR-HCM (Clinical Evaluation of Dosing with Aficamten to Reduce Obstruction in a Pediatric Population in HCM), a clinical trial of aficamten in a pediatric population with symptomatic obstructive hypertrophic cardiomyopathy (HCM), is open to enrollment”
Q4
Enroll.CK-4021586 (CK-586)
“The data support the advancement of CK-586 to a Phase 2 clinical trial in patients with heart failure with preserved ejection fraction (HFpEF) which is expected to begin in Q4 2024.”
2025
NDAAficamten
“a $175.0 million Tranche 7 Term Loan drawable at Cytokinetics' discretion within 1 year of a future U.S. Food and Drug Administration ("FDA") approval of aficamten in obstructive hypertrophic cardiomyopathy if such approval is obtained on or prior to December 31, 2025.”
MAR 10
INDAficamten
“Cytokinetics has completed its midcycle review with the Food and Drug Administration ("FDA") with respect to the New Drug Application ("NDA") for aficamten for the treatment of obstructive hypertrophic cardiomyopathy.”
MAR 10
AdComAficamten
“FDA has informed Cytokinetics that it does not plan to convene an advisory committee meeting to review the Company's NDA for aficamten.”
DEC 26
PDUFAAficamten
“the U.S. Food and Drug Administration ("FDA") has extended the Prescription Drug User Fee Act ("PDUFA") action date for the New Drug Application ("NDA") for aficamten for the treatment of patients with obstructive hypertrophic cardiomyopathy ("oHCM") to December 26, 2025”