Deadline for Applications is September 16th, 2024 "For more than 25 years, our company has proudly championed patient advocacy, diversity, equity and inclusion initiatives, as well as research in our therapeutic focus areas of interest, and we have provided funding to non-profit organizations devoted to our shared mission," said Diane Weiser, Cytokinetics' Senior Vice President, Corporate Affairs. "We are pleased to now evolve our Corporate Giving Program to align with our maturing Corporate Responsibility ...

Core Viewpoint - The upcoming earnings report for Cytokinetics is critical, with expectations for a quarterly loss of $1.02 per share, reflecting a year-over-year change of +23.9% [2]. The stock's movement will depend on whether these numbers meet or exceed expectations [1]. Earnings Expectations - Analysts have maintained the consensus EPS estimate over the last 30 days, indicating a stable outlook from covering analysts [3]. The Zacks Earnings ESP for Cytokinetics is +20.45%, suggesting a bullish sentiment among analysts regarding the company's earnings prospects [21]. Revenue Projections - Revenues for Cytokinetics are projected to be $13.5 million, representing a significant increase of 1451.7% from the same quarter last year [12]. Historical Performance - Cytokinetics has not beaten consensus EPS estimates in the last four quarters, which may influence investor sentiment despite the current positive indicators [9]. In the last reported quarter, the company was expected to post a loss of $1.16 per share but actually reported a loss of $1.33, resulting in a surprise of -14.66% [17]. Predictive Models - The Zacks Earnings ESP model indicates that a positive Earnings ESP is a strong predictor of an earnings beat, especially when combined with a Zacks Rank of 1 (Strong Buy), 2 (Buy), or 3 (Hold) [6]. Stocks with this combination have historically produced a positive surprise nearly 70% of the time [6]. Investment Considerations - While Cytokinetics appears to be a compelling earnings-beat candidate, investors should consider other factors beyond earnings expectations when making investment decisions [10]. The sustainability of any immediate price changes will largely depend on management's discussion during the earnings call [11].

Analyses of Safety and Outcomes from FOREST-HCM Related to Withdrawal of Standard of Care Medications to be Presented Late Breaking Clinical Trials Title: Impact of Aficamten on Echocardiographic Cardiac Structure and Function in Adults with Symptomatic Obstructive Hypertrophic Cardiomyopathy Presenter: Sheila Hegde, M.D., M.P.H., Cardiovascular Medicine Specialist, Division of Cardiovascular Medicine, Brigham and Women's Hospital Date: September 1, 2024 Topic: European Society of Cardiology Session Title: ...

Core Insights - Cytokinetics is conducting a Phase 1 bridging study to evaluate the pharmacokinetics of aficamten in healthy Japanese adults, which is essential for potential approval in Japan [1][9] - Aficamten is a selective cardiac myosin inhibitor designed to reduce myocardial hypercontractility associated with hypertrophic cardiomyopathy (HCM) [2] - The company plans to submit a New Drug Application (NDA) to the FDA in Q3 2024 and a Marketing Authorization Application (MAA) to the EMA in Q4 2024 [6] Company Overview - Cytokinetics is a late-stage biopharmaceutical company focused on developing first-in-class muscle activators and next-in-class muscle inhibitors for diseases affecting cardiac muscle performance [14] - The company has a history of innovation in muscle biology and pharmacology, targeting conditions of muscle dysfunction and weakness [7] Clinical Development - The Phase 1 study will involve 70 healthy participants, including both Japanese and Caucasian individuals, to assess the pharmacokinetics, safety, and tolerability of aficamten [5] - Aficamten is also being evaluated in multiple Phase 3 clinical trials, including MAPLE-HCM, ACACIA-HCM, and CEDAR-HCM, focusing on different patient populations with HCM [11] Regulatory Pathway - Aficamten has received Breakthrough Therapy Designation from the FDA for the treatment of symptomatic obstructive HCM, indicating its potential significance in addressing this condition [6] - The company is preparing for regulatory submissions in both the U.S. and Europe, with expectations to file applications within the next year [6][7]

SOUTH SAN FRANCISCO, Calif., June 17, 2024 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that the first participants have been dosed in a Phase 1 study evaluating the pharmacokinetics, safety and tolerability of aficamten in healthy Japanese and Caucasian participants. "We are conducting this Phase 1 bridging study to characterize the pharmacokinetics of aficamten in healthy Japanese adults and to gather evidence that we believe will be required for potential approval in Japa ...

SOUTH SAN FRANCISCO, Calif., June 04, 2024 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that on May 31, 2024 it granted stock options to purchase an aggregate of 53,417 shares of common stock, 34,684 restricted stock units (RSUs) that will be settled in shares of common stock upon vesting and 34,426 performance stock units (PSUs) that, if earned, will be settled in shares of common stock upon vesting to Sung H. Lee, the Company's Executive Vice President and Chief Financial ...

CYTOKINETICS® and the CYTOKINETICS and C-shaped logo are registered trademarks of Cytokinetics in the U.S. and certain other countries. Jefferies Global Healthcare Conference: Robert I. Blum, President and Chief Executive Officer, and Andrew Callos, Executive Vice President and Chief Commercial Officer, will participate in a fireside chat on Wednesday, June 5, 2024 at 2:00 PM Eastern Time at the New York Marriott Marquis Hotel in New York, NY. 45th Annual Goldman Sachs Healthcare Conference: Robert I. Blum, ...

SOUTH SAN FRANCISCO, Calif., May 28, 2024 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced the closing of its previously announced underwritten public offering of 9,803,922 shares of its common stock at a price to the public of $51.00 per share. The gross proceeds to Cytokinetics from the offering, before offering expenses payable by Cytokinetics, were approximately $500 million. J.P. Morgan, Goldman Sachs & Co. LLC and Morgan Stanley acted as joint book-running managers for the ...

Group 1 - Cytokinetics, Incorporated has successfully closed its underwritten public offering of 9,803,922 shares of common stock at a price of $51.00 per share, resulting in gross proceeds of approximately $500 million before offering expenses [1][2][3] - The offering was managed by J.P. Morgan, Goldman Sachs & Co. LLC, and Morgan Stanley as joint book-running managers [2] - The securities were offered under a shelf registration statement filed with the SEC on November 18, 2022, which has become automatically effective [3]

Core Viewpoint - Cytokinetics (CYTK) shares fell over 17% following a complex funding deal with Royalty Pharma (RPRX) and a public offering priced at a 16% discount to the previous closing price, raising concerns among investors about the deal's structure and implications for future buyouts [1][8]. Funding Deal with Royalty Pharma - The funding deal expands the existing collaboration with Royalty Pharma, allowing Cytokinetics to receive up to $575 million in total [1]. - Cytokinetics will receive $50 million upfront and could access an additional $175 million within 12 months post-approval of aficamten for obstructive hypertrophic cardiomyopathy (oHCM), repayable over 10 years [2]. - The deal revises a previous royalty agreement, with Royalty Pharma now entitled to 4.5% on annual net sales up to $5 billion and 1% above that, compared to the previous terms of 4.5% up to $1 billion and 3.5% thereafter [3]. Additional Funding for Drug Development - Cytokinetics will receive $100 million upfront for a late-stage study on omecamtiv mecarbil, with potential fixed payments and royalties contingent on FDA approval [4]. - An additional $50 million will fund a proof-of-concept study for CK-586, with Royalty Pharma having the option to invest up to $150 million for late-stage development [5]. - Royalty Pharma will also invest $50 million in Cytokinetics' common stock, totaling $250 million upon closing the transaction [6]. Investor Sentiment and Market Impact - Despite the funding boost, investor sentiment is negative due to the deal's complexity and perceived favorability towards Royalty Pharma, raising concerns about long-term payment liabilities [7]. - The deal is seen as reducing the likelihood of a buyout, particularly after Novartis reportedly dropped interest in acquiring Cytokinetics [8]. - Year-to-date, Cytokinetics' stock has declined by 41.3%, contrasting with a 4.4% decline in the industry [8]. Public Offering Details - Cytokinetics announced a secondary offering of approximately 9.8 million shares at $51 per share, aiming to raise $500 million, with a potential total of $575 million if underwriters fully exercise their options [10][11]. - The offering price represents a discount compared to the previous closing price of $59.23, contributing to investor dissatisfaction [12]. Pipeline and Regulatory Plans - With no marketed products, Cytokinetics relies on its pipeline for growth, with plans to submit regulatory filings for aficamten in oHCM to the FDA in Q3 2024 and to the EMA in Q4 2024 [13]. - If approved, aficamten will compete with Bristol Myers' Camzyos, the first FDA-approved drug for oHCM [14].