Cytokinetics (CYTK) Up Despite Unfavorable FDA Committee Voting
Shares of Cytokinetics, Incorporated CYTK jumped 8.04% on Dec 14 even though the FDA Cardiovascular and Renal Drugs Advisory Committee (CRDAC) voted 8 to 3 that the benefits of omecamtiv mecarbil do not outweigh its risks for the treatment of heart failure with reduced ejection fraction (HFrEF).
It seems the investors were unperturbed by CRDAC’s unfavorable voting and are pinning hopes on the company’s overall pipeline.
Omecamtiv mecarbil is an investigational, selective, small-molecule cardiac myosin activator.
The Advisory Committee’s recommendation was based on the results of GALACTIC-HF (Global Approach to Lowering Adverse Cardiac Outcomes Through Improving Contractility in Heart Failure), a phase III study that enrolled 8,256 patients with HFrEF who were at high risk of hospitalization and death despite being well treated on standard-of-care therapy.
The study demonstrated a statistically significant effect of treatment with omecamtiv mecarbil on reducing the risk of the primary composite endpoint of cardiovascular death or heart failure events compared to a placebo in patients treated with standard of care.
The new drug application (NDA) for omecamtiv mecarbil is currently under review by the FDA, with a target action date of Feb 28, 2023. The FDA will consider the CRDAC’s recommendation in its review of the NDA but isn’t bound by it. The company’s path has been turbulent.
We remind investors that the FDA had earlier set a target action date of Nov 30, 2022 for the NDA and indicated that it was not currently planning to hold an advisory committee meeting to discuss the NDA. The regulatory body informed the company on May 17, 2022, that it was planning to convene an advisory committee meeting to discuss the NDA.
On June 17, 2022, Cytokinetics announced that it provided additional pharmacokinetic analyses of omecamtiv mecarbil related to its NDA to the FDA in response to its request. After an initial review of the company’s submission, the FDA communicated that the additional data provided constituted a major amendment to the NDA and extended the target action date by three months to Feb 28, 2023, to provide time for a full review of the submission.
Shares of Cytokinetics have lost 9.2% so far this year against the industry’s decrease of 17.7%.
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Cytokinetics recently announced that the first participant has been dosed in a phase I single and multiple ascending dose study of CK-3828136 (CK-136), formerly known as AMG 594. The candidate was discovered under a previous joint research program with Amgen AMGN and is being evaluated for the potential treatment of patients with HFrEF and other types of heart failure.
Amgen previously conducted randomized single and multiple ascending doses, single-center phase I study to assess the safety and tolerability, pharmacokinetics and pharmacodynamics of CK-136 in healthy subjects.
Other candidates in Cytokinetics’ pipeline are aficamten and reldesemtiv. Aficamten is a next-in-class cardiac myosin inhibitor that is being evaluated in the phase III SEQUOIA-HCM study in patients with symptomatic obstructive hypertrophic cardiomyopathy (HCM). Aficamten is also being evaluated in non-obstructive HCM in Cohort 4 of the phase II study, REDWOOD-HCM.
Reldesemtiv, an investigational fast skeletal muscle troponin activator, is being evaluated in the phase III COURAGE-ALS study in patients with amyotrophic lateral sclerosis (ALS).
Cytokinetics currently carries a Zacks Rank #3 (Hold). A couple of better-ranked stocks in the sector are Gilead Sciences, Inc. GILD and VistaGen Therapeutics VTGN, both carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Earnings estimates for Gilead Sciences have increased 48 cents in the last 60 days to $7.09. Gilead has surpassed earnings estimates in three of the past four quarters with an average positive beat of 0.36%.
Loss estimates for VistaGen have narrowed one cent in the last 60 days to 28 cents. VTGN has surpassed earnings estimates in two of the past four quarters with an average negative beat of 1.74%.
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