Cytokinetics(CYTK)

搜索文档
Cytokinetics Announces Four Upcoming Presentations at the European Society Of Cardiology Heart Failure 2025 Congress
GlobeNewswire News Room· 2025-05-09 04:00
SOUTH SAN FRANCISCO, Calif., May 08, 2025 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced three Late Breaking Science presentations and one ePoster presentation at Heart Failure 2025, an International Congress of the European Society of Cardiology, taking place in Belgrade, Serbia from May 17, 2025 – May 20, 2025. Late Breaking Science Presentations Title: Efficacy and Safety of Aficamten in Patients with Obstructive Hypertrophic Cardiomyopathy and Mild SymptomsPresenter: Iacop ...
Cytokinetics to Hold Annual Meeting of Stockholders
GlobeNewswire· 2025-05-08 04:00
Forward-Looking Statements This press release contains forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995 (the "Act"). Cytokinetics disclaims any intent or obligation to update these forward-looking statements and claims the protection of the Act's Safe Harbor for forward-looking statements. Examples of such statements include, but are not limited to, statements relating to Cytokinetics' and its partners' research and development activities of Cytokinetics' produ ...
Cytokinetics Q1 Earnings Beat, Aficamten Target Action Date Extended
ZACKS· 2025-05-08 02:15
Cytokinetics, Incorporated (CYTK) reported a net loss of $1.36 per share for the first quarter of 2025, narrower than the Zacks Consensus Estimate of a loss of $1.41. In the year-ago quarter, the company reported a net loss of $1.33 per share. (Find the latest EPS estimates and surprises on Zacks Earnings Calendar.)The year-over-year deterioration was due to higher operating expenses.Cytokinetics is a late-stage, specialty cardiovascular biopharmaceutical company focused on discovering, developing and comme ...
Cytokinetics: Strong Buy As FDA's 3-Month Delay Doesn't Derail Aficamten's Approval Outlook
Seeking Alpha· 2025-05-07 23:29
Analyst’s Disclosure: I/we have no stock, option or similar derivative position in any of the companies mentioned, but may initiate a beneficial Long position through a purchase of the stock, or the purchase of call options or similar derivatives in CYTK over the next 72 hours. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article. Seeking ...
Cytokinetics (CYTK) 2025 Conference Transcript
2025-05-07 23:00
纪要涉及的行业和公司 - 行业:心脏病学、制药行业 - 公司:Cytokinetics,一家专注于肌肉生物学的专业心脏病学公司 纪要提到的核心观点和论据 产品管线与研究进展 - **Aficamtan** - 用于治疗梗阻性肥厚型心肌病(OHCM)的PDUFA日期为今年12月,基于SEQUOIA研究及其开放标签扩展FORUST,该药物在主要和次要终点上对OHCM患者有显著临床意义的效果 [1][3] - 另一项Maple HCM研究本月将公布结果,与SEQUOIA和FORUST研究共同为OHCM患者带来新药物的希望 [3] - 针对非梗阻性肥厚型心肌病(NHCM)的Acacia研究已提前近六个月完成入组,预计明年上半年公布结果,若结果积极,Aficamtan可能成为首个获批用于NHCM的心脏肌球蛋白抑制剂 [3][26] - **Omecamtiv mecarbil**:正在研究用于治疗射血分数降低的心力衰竭患者 [4] - **CK586**:正在研究用于治疗射血分数保留的心力衰竭(HFpEF),今年晚些时候将完成前两个队列的入组 [35] FDA审查与PDUFA延期 - FDA在审查过程中未对提交的数据和获批潜力提出重大反对或问题,与公司在多个层面进行了积极互动,监管流程按计划进行 [5][6][7] - PDUFA延期三个月,原计划10月推出产品,现若12月获批,可避免在11月假期期间推出,更有利于建立市场动力 [15] 产品差异化优势 - **临床设计与疗效**:Aficamtan设计目标是简化给药,可快速增加剂量,在短时间内缓解症状,超过目标剂量时降低剂量效果可在短时间内消退,且药物相互作用可预测,能提高疗效 [10][11] - **商业角度**:在疗效、安全性和REMS方面与Kamsios有差异,Maple研究有助于扩大市场至普通心脏病学领域,若Acacia研究结果积极,将带来更多动力和光环效应 [12][13][14] 研究设计与信心来源 - **Maple研究**:设计该研究是为了证明Aficamtan单药治疗相对于标准治疗β - 阻滞剂的优势,以提升其成为标准治疗的地位,成功标准包括至少1.5 - 2.0的峰值VO2增加以及良好的安全性和耐受性 [21][23][24] - **Acacia研究**:快速入组得益于研究人员对药物作用机制的热情和与临床团队的密切合作,公司对Aficamtan在NHCM中的疗效有信心,基于REDWOOD Cohort four数据、良好的II期经验以及精心设计的III期试验 [26][27][31] - **CK586研究**:NHCM研究的结果对HFpEF有直接相关性,研究聚焦于高射血分数、生物标志物升高、心力衰竭症状的人群,以模拟NHCM患者模型 [36][39] 其他重要但可能被忽略的内容 - 公司商业组织招聘了超过4000名心血管代表,竞争约125 - 150个职位,其中超90%有超过十年经验 [18][19] - REDWOOD Cohort four中有约40名患者进入FORUST开放标签扩展,可实时评估药物效果 [34]
CYTK Investors Have Opportunity to Join Cytokinetics, Incorporated Fraud Investigation with the Schall Law Firm
Prnewswire· 2025-05-07 06:12
LOS ANGELES, May 6, 2025 /PRNewswire/ -- The Schall Law Firm, a national shareholder rights litigation firm, announces that it is investigating claims on behalf of investors of Cytokinetics, Incorporated ("Cytokinetics" or "the Company") (NASDAQ: CYTK) for violations of the securities laws.The investigation focuses on whether the Company issued false and/or misleading statements and/or failed to disclose information pertinent to investors. Cytokinetics is the subject of a report published by BioPharma Dive ...
Cytokinetics(CYTK) - 2025 Q1 - Quarterly Report
2025-05-07 04:30
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2025 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 000-50633 CYTOKINETICS, INCORPORATED (Exact name of registrant as specified in its charter) Delaware 94-3291317 ( ...
Cytokinetics(CYTK) - 2025 Q1 - Earnings Call Transcript
2025-05-07 04:30
Cytokinetics (CYTK) Q1 2025 Earnings Call May 06, 2025 04:30 PM ET Speaker0 Good afternoon, and welcome to Cytokinetics First Quarter twenty twenty five Conference Call. At this time, I would like to inform you that this call is being recorded and that all participants are in a listen only mode. At the company's request, we will open the call to questions after the presentation. We will allow for only one question per participant. I will now turn the call over to Diane Weiser, Cytokinetics' Senior Vice Pres ...
Cytokinetics(CYTK) - 2025 Q1 - Earnings Call Transcript
2025-05-07 04:30
Cytokinetics (CYTK) Q1 2025 Earnings Call May 06, 2025 04:30 PM ET Company Participants Diane Weiser - Senior Vice President of Corporate Communications & Investor RelationsRobert Blum - President and CEOAndrew Callos - Executive VP & Chief Commercial OfficerFady Malik - Executive Vice President of Research & DevelopmentStuart Kupfer - Senior VP & Chief Medical OfficerIsaac Ciechanover - EVP, Corporate Development and Chief Business OfficerSung Lee - Executive VP & CFOSean McCutcheon - Vice President - Biot ...
Cytokinetics(CYTK) - 2025 Q1 - Earnings Call Transcript
2025-05-07 04:30
Cytokinetics (CYTK) Q1 2025 Earnings Call May 06, 2025 04:30 PM ET Company Participants Diane Weiser - Senior Vice President of Corporate Communications & Investor RelationsRobert Blum - President and CEOAndrew Callos - Executive VP & Chief Commercial OfficerFady Malik - Executive Vice President of Research & DevelopmentStuart Kupfer - Senior VP & Chief Medical OfficerIsaac Ciechanover - EVP, Corporate Development and Chief Business OfficerSung Lee - Executive VP & CFOSean McCutcheon - Vice President - Biot ...