The FDA will likely approve the small molecule for Cytokinetics Inc. In the first quarter of 2013, during which the PDUFA is scheduled, according to a HC Wainwright & Co.
History of the original PDUFA for Cytokinetics Inc.’s (CYTK:NASDAQ) omecamtiv mecarbil has just been extended for three months, through February 28, 2023, by the U.S. Food and Drug Administration (FDA) to review additional data it requested regarding a new drug application (NDA), according to HC Wainwright & Co analyst Joseph. Pantginis in a research note dated June 17.
“Our confidence in Omicamtive’s approval remains unchanged, and we expect the drug to be released in the first quarter of 23,” Pantgenis wrote.
Omecamtiv mecarbil is a California-based lead biopharma candidate, awaiting approval for heart failure. While delaying the PDUFA appointment is not ideal for patients with this medical condition, it allows cytokines more time to prepare for commercial release, Pantginis noted.
Also positive for the California-based biopharma, Pantgenis wrote, “talks continue about the drug’s potential partnership (EU and Japan) and should boost the company’s undiluted funding.”
Pantginis explained that the additional pharmacokinetic data provided to the FDA upon request are consistent with and do not change any of the conclusions the company has already reached about omecamtiv mecarbil based on its analyzes of all available information. As such, HC Wainwright’s thesis on the biopharmaceutical company remains the same.
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What’s next regarding omecamtiv’s non-disclosure agreement are two meetings. One, not yet scheduled, will be for the Food and Drug Administration and its advisory committee.
The second is the late-cycle meeting, likely later this year, between the Food and Drug Administration and cytokinetics. This event, Pantjenis pointed out, is an opportunity for biopharmaceuticals to replicate the benefits of omecamtiv and, as key opinion leaders emphasized, the potential for physician uptake.
In other news, Pantginis reports that Cytokinetics presented, at the 2022 American Society of Echocardiography Conference, confirming experimental results of aficamtem, which the company is developing as a treatment for obstructive and non-obstructive hypertrophic cardiomyopathy as well as heart failure while maintaining ejection fraction.
These data regarding aficamtem and hypertrophic obstructive cardiomyopathy, according to Pantginis, indicate that the drug rapidly provides effective and safe clinical benefits. They added to previously reported evidence of improvement in cardiac function (rest and raised left ventricular outflow tract obstruction), patient symptoms (NY Heart Association class improvement in majority of treated patients), and remodeling (decrease in plasma) N terminal pro hormone. BNP). “
Various data, presented by cytokinetics at the 2022 Heart Failure Conference of the European Society of Cardiology, showed that the benefits of aficamtem were sustained over the long term, 12 and 24 weeks, without lowering the left ventricular ejection fraction below 50% and without interruption of dosing or drug discontinuation. .
Biopharma has Aficamtem trials underway and plans for another.
“Further analysis could contribute to highlighting the characteristics of the trainees, their potential location in the hypertrophic cardiomyopathy landscape, as well as accelerating its progression in non-obstructive hypertrophic cardiomyopathy,” Pantgenis wrote.
HC Wainwright has a buy rating and a $75 target price per share on Cytokinetics, with a current share price of approximately $40.58.
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HCWainwright & Co. Disclosures, CytokineticsInc. June 17, 2022
HC Wainwright & Co, LLC (the “Company”) is a member of FINRA, SIPC, and a US registered broker-dealer.
I’m Joseph Pantgenis, Ph.D. and Emanuela Branchte, Ph.D. certify that 1) all opinions expressed in this report accurately reflect my personal opinions about any and all subject securities or issuers discussed; and 2) no part of my salary was, or would be, directly or indirectly related to the specific recommendation or opinions expressed in this research report; 3) Neither I nor any of my family members is an official, director, or member of the advisory board of these companies.
Neither the research analyst nor the research analyst family has a financial interest in the securities of Cytokinetics, Inc. (including, without limitation, any option, right, security, future, long or short position). As of May 31, 2022, neither the Company nor its subsidiaries beneficially own 1% or more of any class of Cytokinetics, Inc.’s common stock. Neither the Research Analyst nor the Company knows or has reason to know of any material conflict of interest. At the time of publication of this research report.
The research analyst primarily responsible for preparing the report does not receive compensation based on any specific investment banking services or transactions, but is compensated based on factors including total revenue and the company’s profitability, a large part of which is derived from investment banking services. The Company or its affiliates have received compensation from Cytokinetics, Inc. For non-investment banking services in the past 12 months.
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