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Cytokinetics Announces Start of COMET-HF, a Confirmatory Phase 3 Clinical Trial of Omecamtiv Mecarbil in Patients with Symptomatic Heart Failure with Severely Reduced Ejection Fraction
03 Dec 2024 12:30 GMT
… the trial. About Omecamtiv Mecarbil Omecamtiv mecarbil is an investigational, … has shown that omecamtiv mecarbil increases cardiac contractility … omecamtiv mecarbil, demonstrated a statistically significant effect of treatment with omecamtiv mecarbil …
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Cytokinetics to Announce First Quarter Results on May 6, 2025
22 Apr 2025 20:00 GMT
… HCM. Cytokinetics is also developing omecamtiv mecarbil, a cardiac myosin activator, in …
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Human medicines European public assessment report (EPAR): Kinharto, Omecamtiv mecarbil, Date of refusal: 07/05/2024, Status: Withdrawn application
31 May 2024 14:36 GMT
Based on the review of the data and the company’s response to the Agency’s questions, at the time of the withdrawal, the Agency had concerns and its provisional opinion was that Kinharto could not be authorised for the treatment of chronic (long-term) …
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Cytokinetics Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)
17 Apr 2025 20:00 GMT
… HCM. Cytokinetics is also developing omecamtiv mecarbil, a cardiac myosin activator, in …
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FDA Declines Approval for Omecamtiv Mecarbil in HFrEF
01 Mar 2023 20:08 GMT
… advisers recommended against approval of omecamtiv mecarbil for chronic HFrEF, as reported … by theheart.org | Medscape Cardiology, omecamtiv mecarbil produced a positive result for … an additional clinical trial of omecamtiv mecarbil are required to establish …
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Cytokinetics Receives Complete Response Letter From FDA for New Drug Application for Omecamtiv Mecarbil
28 Feb 2023 22:31 GMT
… Drug Application (NDA) for omecamtiv mecarbil, an investigational, selective, … access the call. About Omecamtiv Mecarbil Omecamtiv mecarbil is an investigational, selective, … research has shown that omecamtiv mecarbil increases cardiac contractility without …
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FDA Panel Votes No on Omecamtiv Mecarbil for Heart Failure
14 Dec 2022 21:19 GMT
… has recommended against approval of omecamtiv mecarbil (Cytokinetics) for the treatment of … reduced ejection fraction (HFrEF).
Omecamtiv mecarbil is a first-in-class … by theheart.org | Medscape Cardiology, omecamtiv mecarbil produced a positive result for …
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Cytokinetics Announces Outcome of FDA Advisory Committee Vote On Omecamtiv Mecarbil
14 Dec 2022 02:20 GMT
… the application for omecamtiv mecarbil."
Omecamtiv mecarbil is an investigational, … access the call.
About Omecamtiv Mecarbil
Omecamtiv mecarbil is an investigational, selective … has shown that omecamtiv mecarbil increases cardiac contractility without …
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FDA panel declines to support approval of omecamtiv mecarbil
14 Dec 2022 00:53 GMT
… from GALACTIC-HF demonstrated that omecamtiv mecarbil (Cytokinetics), a novel selective … significant improvement for subjects on omecamtiv mecarbil compared to placebo,” the … data showing excessive exposure to omecamtiv mecarbil increased risk for myocardial …
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Cytokinetics Announces Outcome of FDA Advisory Committee Vote On Omecamtiv Mecarbil
13 Dec 2022 22:45 GMT
… of the application for omecamtiv mecarbil.” Omecamtiv mecarbil is an investigational, selective … the call. About Omecamtiv Mecarbil Omecamtiv mecarbil is an investigational, selective … has shown that omecamtiv mecarbil increases cardiac contractility without …
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