FDA Rejects Cytokinetics' Heart Failure Treatment Candidate - Cytokinetics (NASDAQ:CYTK)

The FDA issued a Complete Response Letter to Cytokinetics Incorporated's CYTK omecamtiv mecarbil, an investigational, selective, small molecule cardiac myosin activator, for heart failure with reduced ejection fraction (HFrEF).
In December, the FDA's Cardiovascular and Renal Drugs Advisory Committee voted 8-3 against the approval omecamtiv mecarbil.
Adcomm members said the drug's potential benefits did not seem to outweigh its risks, with panel members raising concerns about its safety and limited efficacy.
FDA said that GALACTIC-HF is not sufficiently persuasive to establish substantial evidence of effectiveness for reducing the risk of heart failure events and cardiovascular death instead of evidence from at least two adequate and well-controlled clinical investigations.
FDA stated that results from an additional clinical trial of omecamtiv mecarbil are required to establish substantial evidence of effectiveness for the treatment of HFrEF, with benefits that outweigh the risks.
Cytokinetics expects to request a meeting with FDA to understand the FDA's views regarding the CRL and what may be required to support the potential approval of omecamtiv mecarbil.
However, the company has no plans to conduct an additional clinical trial of omecamtiv mecarbil.
Its focus remains on the development program for aficamten, the next-in-class cardiac myosin inhibitor subject of the SEQUOIA-HCM Phase 3 trial for obstructive hypertrophic cardiomyopathy (HCM).
Price Action: CYTK shares are down 0.44% at $43.17 on the last check Wednesday.

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