Tag: HFrEF

Cytokinetics Announces Outcome of FDA Advisory Committee Vote On Omecamtiv Mecarbil

Coronary/Structural Heart Regulatory by 0 comments

PDUFA Target Action Date is February 28, 2023 Cytokinetics to Host Conference Call and Webcast on December 14, 2022 at 8:30 am Eastern Time SOUTH SAN FRANCISCO, Calif., Dec. 13, 2022 (GLOBE NEWSWIRE) — Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that the U.S. Food & Drug Administration (FDA) Cardiovascular and Renal […]

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Salubris Biotherapeutics Announces Updated Phase 1b Data Demonstrating that JK07, the First Investigational Antibody Fusion Protein for Heart Failure, Resulted in Clinically Meaningful Improvements in Ejection Fraction

Coronary/Structural Heart by 0 comments

– Completed Second Cohort Showed an Average 30% Relative Increase in Ejection Fraction (EF) at 90 Days Following a Single Administration of JK07 – – Cohort 3 Sentinel Subject Demonstrated a >70% Relative EF Increase at Day 30 – – Company also Announces the First CTA Approval for JK08, the First […]

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Intra-Cellular Therapies Announces Positive Top-line Results from ITI-214 Phase I/II Study in Patients with Heart Failure

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Study demonstrated inhibiting phosphodiesterase-1 with ITI-214 in patients with heart failure improved cardiac function by enhancing cardiac contractility and dilating systemic arteries without inducing abnormal heart rhythms. NEW YORK, June 29, 2020 (GLOBE NEWSWIRE) — Intra-Cellular Therapies, Inc. (Nasdaq:ITCI) today announced topline results from Study ITI-214-104, a Phase I/II translational study […]

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