Tag Archives: Amgen

Amgen Returns Omecamtiv Rights to Cytokinetics; Risk-reward for CYTK Hinges on FDA Adcom

Amgen (press release) and Cytokinetics (press release) separately announced Amgen provided notice to Cytokinetics of its intention to return development and commercial rights for omecamtiv mecarbil (cardiac myosin activator) and AMG 594 (cardiac troponin activator). Cytokinetics also hosted a call with investors to provide commentary regarding Amgen’s decision and next steps for omecamtiv. Below, FENIX provides thoughts on Amgen’s decision, in the context of other recent partnership dissolution examples, as well as implications from the upcoming Entresto FDA adcom.

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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.

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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.

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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.

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