Tag Archives: Amgen

Omecamtiv Misses on Primary Outcome Components, Hits on LVEF <28% Subgroup; GALACTIC-HF @ AHA 2020

Full results from the GALACTIC-HF trial were presented during the late-breaking clinical trial session at the 2020 AHA conference (view Cytokinetics press release) and simultaneously published in the NEJM (view publication here). Cytokinetics hosted a subsequent call with investors to discuss the trial results. Below, FENIX provides thoughts on the GALACTIC-HF results in the context of the HF market.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

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GALACTIC-HF Results Disappoint; Omecamtiv Approval, but Utility is Questionable

Amgen, Cytokinetics, and Servier announced topline results from the Ph3 GALACTIC–HF trial, evaluating omecamtiv mecarbil in patients with HFrEF. Results demonstrated a statistically significant 8% RRR in the primary composite endpoint (CV death or HF events) but failed to show a benefit in CV death alone. Below, FENIX provides an overview of the topline data and thoughts on the results.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

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Purchase Blast$599.00

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Sotagliflozin, Finerenone, and Omecamtiv CVOTs @ AHA 2020

The AHA 2020 late-breaking abstract titles have been published and include the sotagliflozin (SOLOIST-WHF and SCORED), finerenone (FIDELIO-DKD), and omecamtiv mecarbil (GALACTIC-HF) CVOTs (view all AHA late-breaking topics here). Recall, Bayer announced positive topline results from FIDELIO-DKD in July 2020 (previous FENIX insight). Lexicon has not released any topline results from the SOLOIST-WHF and SCORED trials, which were closed out early following the Sanofi partnership dissolution (previous FENIX insight). As such, the SCORED and SOLOIST-WHF results are highly anticipated.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

If you receive our email blasts, you already have an account.

Purchase Blast$599.00

You can read the article’s full content online after purchase.