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.
|Want to be the first to know about interesting Biotechnology / Pharmaceuticals investment ideas? Sign up to receive the FREE Streetwise Reports' newsletter.||Subscribe|
1) Doresa Banning wrote this article for Streetwise Reports LLC and provides services to Streetwise Reports as an independent contractor. She or members of her household own securities of the following companies mentioned in the article: None. She or members of her household are paid by the following companies mentioned in this article: None.
2) The following companies mentioned in this article are billboard sponsors of Streetwise Reports: None. Click here for important disclosures about sponsor fees.
3) Comments and opinions expressed are those of the specific experts and not of Streetwise Reports or its officers. The information provided above is for informational purposes only and is not a recommendation to buy or sell any security.
5) From time to time, Streetwise Reports LLC and its directors, officers, employees, or members of their families, as well as persons interviewed for articles and interviews on the site, may have a long or short position in the securities mentioned. Directors, officers, employees, or members of their immediate families are prohibited from making purchases and/or sales of those securities in the open market or otherwise from the time of the decision to publish an article until three business days after the publication of the article. The foregoing prohibition does not apply to articles that in substance only restate previously published company releases.
6) This article does not constitute medical advice. Officers, employees, and contributors to Streetwise Reports are not licensed, medical professionals. Readers should always contact their healthcare professionals for medical advice.
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.
The securities of the company discussed in this report may be unsuitable for investors depending on their specific investment objectives and financial position. Past performance is no guarantee of future results. This report is offered for informational purposes only, and does not constitute an offer or solicitation to buy or sell any securities discussed herein in any jurisdiction where such would be prohibited. This research report is not intended to provide tax advice or to be used to provide tax advice to any person. Electronic versions of H.C. Wainwright & Co., LLC research reports are made available to all clients simultaneously.
No part of this report may be reproduced in any form without the expressed permission of H.C. Wainwright & Co., LLC. Additional information available upon request. H.C. Wainwright & Co., LLC does not provide individually tailored investment advice in research reports. This research report is not intended to provide personal investment advice and it does not take into account the specific investment objectives, financial situation and the particular needs of any specific person. Investors should seek financial advice regarding the appropriateness of investing in financial instruments and implementing investment strategies discussed or recommended in this research report.
H.C. Wainwright & Co., LLC’s and its affiliates’ salespeople, traders, and other professionals may provide oral or written market commentary or trading strategies that reflect opinions that are contrary to the opinions expressed in this research report. H.C. Wainwright & Co., LLC and its affiliates, officers, directors, and employees, excluding its analysts, will from time to time have long or short positions in, act as principal in, and buy or sell, the securities or derivatives (including options and warrants) thereof of covered companies referred to in this research report. The information contained herein is based on sources which we believe to be reliable but is not guaranteed by us as being accurate and does not purport to be a complete statement or summary of the available data on the company, industry or security discussed in the report. All opinions and estimates included in this report constitute the analyst’s judgment as of the date of this report and are subject to change without notice. Securities and other financial instruments discussed in this research report: may lose value; are not insured by the Federal Deposit Insurance Corporation; and are subject to investment risks, including possible loss of the principal amount invested.