LOS ANGELES--(BUSINESS WIRE)---- $CYTK--CYTK Investors Have Opportunity to Lead Cytokinetics, Incorporated Securities Fraud Lawsuit with the Schall Law Firm. ...

Core Viewpoint - A class action lawsuit has been filed against Cytokinetics, alleging that the company made materially false and misleading statements regarding the New Drug Application (NDA) submission and approval process for aficamten, leading to significant investor losses [8]. Allegation Details - The lawsuit claims that Cytokinetics misrepresented the expected timeline for FDA approval of aficamten, stating it would occur in the second half of 2025, while failing to disclose risks related to the omission of a Risk Evaluation and Mitigation Strategy (REMS) [8]. - It was revealed during an earnings call on May 6, 2025, that the company had discussions with the FDA about safety monitoring but chose to submit the NDA without a REMS, misleading investors about the regulatory timeline [8]. Next Steps - Investors who purchased Cytokinetics shares between December 27, 2023, and May 6, 2025, and suffered losses are encouraged to contact the law firm Bragar Eagel & Squire for more information and to discuss their legal rights [4][8]. - The deadline for investors to apply to be appointed as lead plaintiff in the lawsuit is November 17, 2025 [8]. About the Law Firm - Bragar Eagel & Squire, P.C. is a nationally recognized law firm that represents individual and institutional investors in complex litigation across the United States [5].

BENSALEM, Pa.--(BUSINESS WIRE)--Law Offices of Howard G. Smith announces that a class action lawsuit has been filed on behalf of investors who purchased Cytokinetics, Incorporated ("Cytokinetics†or the "Company†) (NASDAQ: CYTK) common stock between December 27, 2023 and May 6, 2025, inclusive (the "Class Period†). Cytokinetics investors have until November 17, 2025 to file a lead plaintiff motion. IF YOU ARE AN INVESTOR WHO SUFFERED A LOSS IN CYTOKINETICS, INCORPORATED (CYTK), CONTACT THE LAW. ...

Core Viewpoint - Cytokinetics, Inc. is facing a class action lawsuit due to alleged misleading statements regarding the New Drug Application (NDA) for aficamten, which may have caused financial losses for investors [1][3]. Group 1: Class Action Details - The class action is on behalf of investors who purchased Cytokinetics securities between December 27, 2023, and May 6, 2025, with a deadline for filing a lead plaintiff motion set for November 17, 2025 [1]. - Investors are encouraged to contact the Portnoy Law Firm for legal rights discussions and case evaluations [2]. Group 2: Allegations Against Cytokinetics - The complaint alleges that during the class period, Cytokinetics made materially false and misleading statements about the NDA submission and approval timeline for aficamten, specifically expecting FDA approval in the second half of 2025 [3]. - The company failed to disclose significant risks related to the submission of a Risk Evaluation and Mitigation Strategy, which could delay the regulatory process, leading to financial losses for shareholders when the truth was revealed [3].

Core Viewpoint - Faruqi & Faruqi, LLP is investigating potential claims against Cytokinetics, Incorporated due to misleading statements regarding the New Drug Application (NDA) for aficamten, which may have led to significant investor losses [4][6][8]. Group 1: Legal Investigation and Class Action - The firm is encouraging investors who suffered losses exceeding $75,000 in Cytokinetics between December 27, 2023, and May 6, 2025, to discuss their legal rights [1]. - A federal securities class action has been filed against Cytokinetics, with a deadline of November 17, 2025, for investors to seek the role of lead plaintiff [4]. - The lead plaintiff is defined as the investor with the largest financial interest in the relief sought by the class, who will oversee the litigation on behalf of the class members [9]. Group 2: Misleading Statements and Regulatory Issues - Defendants allegedly made materially false and misleading statements regarding the timeline for the NDA submission and approval process for aficamten, claiming expected FDA approval in the second half of 2025 [6]. - The company failed to disclose material risks related to the omission of a Risk Evaluation and Mitigation Strategy (REMS), which could delay the regulatory process [6]. - During an earnings call on May 6, 2025, it was revealed that Cytokinetics had multiple pre-NDA meetings with the FDA but chose to submit the NDA without a REMS, misleading investors about the regulatory timeline [7]. Group 3: Impact on Investors - As a result of the misleading statements, class members purchased Cytokinetics' common stock at artificially inflated prices and suffered significant losses when the truth was revealed [8]. - The firm is also encouraging anyone with information regarding Cytokinetics' conduct, including whistleblowers and former employees, to come forward [10].

Group 1 - Cytokinetics, Inc. (NASDAQ:CYTK) experienced a 4.42% drop in share price, closing at $47.56, following the announcement of an upsized senior convertible notes issuance to $650 million [1][3] - The company aims to raise $650 million from the offering, an increase from the initial target of $550 million, with a yield rate of 1.75% until 2031 [2] - Proceeds from the offering will be used to refinance a portion of existing 3.50% convertible senior notes due in 2027 and to support the potential commercial launch of aficamten [3][4] Group 2 - Cytokinetics plans to issue 2.16 million common shares, which is expected to reduce debt by approximately $399.5 million [3] - Any remaining proceeds will also be allocated for general corporate purposes, including the potential retirement of the remaining 2027 notes that were not converted [4] - The company expects to close the sale of the notes on September 19, subject to closing conditions [4]

Core Viewpoint - A securities class action lawsuit has been filed against Cytokinetics, alleging false and misleading statements regarding the New Drug Application for aficamten and its approval timeline [1][2]. Group 1: Lawsuit Details - The lawsuit is filed in the United States District Court for the Northern District of California on behalf of individuals or entities that acquired Cytokinetics securities between December 27, 2023, and May 6, 2025 [1]. - The complaint claims that Cytokinetics misrepresented the expected approval timeline from the FDA for aficamten, indicating a PDUFA date of September 26, 2025, while failing to disclose risks related to the submission of a Risk Evaluation and Mitigation Strategy [2]. Group 2: Investor Information - Investors who purchased Cytokinetics shares are encouraged to contact the law firm before the lead plaintiff motion deadline on November 17, 2025 [3]. - The lead plaintiff will represent the interests of other class members in the litigation process [3].

Core Points - A shareholder class action lawsuit has been filed against Cytokinetics, alleging that the company misrepresented its expectations for FDA approval of aficamten and failed to disclose material risks related to the submission of a Risk Evaluation and Mitigation Strategy (REMS) [1] - The lawsuit claims that Cytokinetics indicated an expectation for FDA approval in the second half of 2025, based on a PDUFA date of September 26, 2025 [1] - The lawsuit is aimed at shareholders who purchased shares between December 27, 2023, and May 6, 2025, and experienced significant losses [2] Legal Information - The deadline for shareholders to request to be appointed as lead plaintiff in the case is November 17, 2025 [3] - Holzer & Holzer, LLC is the law firm representing the shareholders, known for its vigorous representation in securities litigation [3]

Core Insights - Cytokinetics is set to present significant findings related to Aficamten at the Heart Failure Society of America Annual Scientific Meeting 2025, including two Late Breaking Clinical Research presentations and one poster presentation [1][2]. Group 1: Presentations Overview - The first Late Breaking Clinical Research presentation will focus on the safety and efficacy of Aficamten in patients with nonobstructive hypertrophic cardiomyopathy, featuring a 96-week analysis from the FOREST-HCM study [2]. - The second Late Breaking Clinical Research presentation will analyze the divergent effects of Aficamten versus Metoprolol on exercise performance in obstructive hypertrophic cardiomyopathy, based on a prespecified analysis of the MAPLE-HCM study [2]. - A poster presentation will discuss the association of sociodemographic characteristics and healthcare costs in patients with non-obstructive hypertrophic cardiomyopathy [3]. Group 2: Aficamten Development - Aficamten is an investigational selective cardiac myosin inhibitor designed to reduce myocardial hypercontractility associated with hypertrophic cardiomyopathy (HCM) by binding to cardiac myosin [3][4]. - The drug is currently being evaluated in multiple clinical trials, including SEQUOIA-HCM for symptomatic obstructive HCM, ACACIA-HCM for non-obstructive HCM, and CEDAR-HCM for pediatric patients with obstructive HCM [5][6]. - Aficamten has received Breakthrough Therapy Designation from the FDA for symptomatic HCM and is under regulatory review in the U.S. and Europe, with a target action date of December 26, 2025, for the New Drug Application [4][6]. Group 3: Company Background - Cytokinetics is a biopharmaceutical company specializing in cardiovascular diseases, with over 25 years of experience in muscle biology and a focus on developing new medicines for cardiac muscle dysfunction [7]. - The company is preparing for potential regulatory approvals and commercialization of Aficamten following positive results from pivotal clinical trials [7].

Group 1 - A class action was filed on behalf of individuals and entities that purchased or acquired Cytokinetics, Inc. securities [1] - The relevant period for the class action is from December 27, 2023, to May 6, 2025 [1] - The company involved is Cytokinetics, Inc., which is listed on NASDAQ under the ticker symbol CYTK [1]