Tag Archives: Cytokinetics

Servier Terminates Omecamtiv Agreement; Oramed Oral Leptin PoC Results

Two CV-met news items have been observed: Cytokinetics announced Servier has decided to terminate its sublicense agreement with Amgen for the development and commercialization of omecamtiv in EU and CIS; and Oramed announced topline results from a PoC study of its oral leptin drug candidate. Below, FENIX provides highlights and insights for the respective news items.

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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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