The original PDUFA date for Cytokinetics Inc.'s (CYTK:NASDAQ) omecamtiv mecarbil was just extended three months until Feb. 28, 2023, by the U.S. Food and Drug Administration (FDA) for review of the additional data it requested relative to the new drug application (NDA), reported H.C. Wainwright & Co. analyst Joseph Pantginis in a June 17 research note.
"Our confidence in omecamtiv's approval remains unaltered, and we expect the drug to launch in Q1/23," Pantginis wrote.
Omecamtiv mecarbil is the California-based biopharma's lead drug candidate, awaiting approval in heart failure. Whereas the PDUFA date delay is not ideal for patients with this medical condition, it allows Cytokinetics more time to prepare for the commercial launch, noted Pantginis.
Also positive for the California-based biopharma, Pantginis wrote, "conversations around potential partnering for the drug (European Union and Japan) continue and should further bolster the company's nondilutive funding."
Pantginis highlighted that the further pharmacokinetic data Cytokinetics submitted to the FDA on request is consistent with and does not change any of the conclusions the company already made about omecamtiv mecarbil based on its analyses of all of the available information. As such, H.C. Wainwright's thesis on the biopharma company remains the same.
What's next regarding the NDA for omecamtiv is two meetings. One, yet to be scheduled, will be for the FDA and its Advisory Committee.
The second is a late-cycle meeting, likely to take place later this year, between the FDA and Cytokinetics. This event, Pantginis noted, is an opportunity for the biopharma to reiterate omecamtiv's benefits and, as asserted by key opinion leaders, the likelihood of physician uptake.
In other news, Pantginis reported that Cytokinetics presented, at the American Society of Echocardiography's 2022 conference, affirming trial results of aficamtem, which the company is developing as a treatment for obstructive and nonobstructive hypertrophic cardiomyopathy as well as heart failure with preserved ejection fraction.
These data pertaining to aficamtem and obstructive hypertrophic cardiomyopathy, according to Pantginis, show the drug quickly provides effective and safe clinical benefits. They "add to and corroborate the previously reported evidence of improvement in cardiac function (resting and provoked left ventricular outflow tract obstruction), patients' symptoms (New York Heart Association class improved in the majority of treated patients), and remodeling (reduction in plasma N terminal pro hormone BNP)."
Different data, which Cytokinetics presented at the European Society of Cardiology's 2022 Heart Failure Congress, showed the benefits of aficamtem continued long term, 12 and 24 weeks, without left ventricular ejection fraction drops below 50% and without dosing being interrupted or the drug stopped.
The biopharma has aficamtem trials underway and is planning others.
"Further analysis could contribute to highlighting aficamten's properties, its potential position in the hypertrophic cardiomyopathy landscape as well as to accelerating its development in nonobstructive hypertrophic cardiomyopathy," Pantginis wrote.
H.C. Wainwright has a Buy rating and a $75 per share price target on Cytokinetics, the current share price of which is around $40.58.
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Disclosures for H.C.Wainwright & Co., CytokineticsInc., June 17, 2022
H.C. Wainwright & Co, LLC (the “Firm”) is a member of FINRA and SIPC and a registered U.S. Broker-Dealer.
I, Joseph Pantginis, Ph.D. and Emanuela Branchetti, Ph.D. , certify that 1) all of the views expressed in this report accurately reflect my personal views about any and all subject securities or issuers discussed; and 2) no part of my compensation was, is, or will be directly or indirectly related to the specific recommendation or views expressed in this research report; and 3) neither myself nor any members of my household is an officer, director or advisory board member of these companies.
None of the research analysts or the research analyst’s household has a financial interest in the securities of Cytokinetics, Inc. (including, without limitation, any option, right, warrant, future, long or short position). As of May 31, 2022 neither the Firm nor its affiliates beneficially own 1% or more of any class of common equity securities of Cytokinetics, Inc. Neither the research analyst nor the Firm knows or has reason to know of any other material conflict of interest at the time of publication of this research report.
The research analyst principally responsible for preparation of the report does not receive compensation that is based upon any specific investment banking services or transaction but is compensated based on factors including total revenue and profitability of the Firm, a substantial portion of which is derived from investment banking services. The firm or its affiliates received compensation from Cytokinetics, Inc. for non-investment banking services in the previous 12 months.
The Firm or its affiliates did receive compensation from Cytokinetics, Inc. for investment banking services within twelve months before, and will seek compensation from the companies mentioned in this report for investment banking services within three months following publication of the research report. H.C. Wainwright & Co., LLC managed or co-managed a public offering of securities for Cytokinetics, Inc. during the past 12 months. The Firm does not make a market in Cytokinetics, Inc. as of the date of this research report.
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