Earnings summaries and quarterly performance for CYTOKINETICS.
Executive leadership at CYTOKINETICS.
Board of directors at CYTOKINETICS.
B. Lynne Parshall, Esq.
Director
Edward M. Kaye, M.D.
Director
John T. Henderson, M.B., Ch.B.
Chair of the Board
Muna Bhanji
Director
Nancy J. Wysenski
Director
Robert A. Harrington, M.D.
Director
Robert E. Landry
Director
Wendell Wierenga, Ph.D.
Director
Research analysts who have asked questions during CYTOKINETICS earnings calls.
Jason Butler
JMP Citizens
4 questions for CYTK
Salim Syed
Mizuho Securities
4 questions for CYTK
Tessa Romero
JPMorgan Chase & Co.
4 questions for CYTK
Cory Kasimov
Evercore ISI
3 questions for CYTK
James Condulis
Stifel
3 questions for CYTK
Leonid Timashev
RBC Capital Markets
3 questions for CYTK
Mayank Mamtani
B. Riley Securities
3 questions for CYTK
Sean McCutcheon
Raymond James
3 questions for CYTK
Yasmeen Rahimi
Piper Sandler & Co.
3 questions for CYTK
Akash Tewari
Jefferies
2 questions for CYTK
Charles Duncan
Cantor Fitzgerald & Co.
2 questions for CYTK
Jason Zemansky
Bank of America
2 questions for CYTK
Joseph Pantginis
H.C. Wainwright & Co.
2 questions for CYTK
Kyuwon Choi
Goldman Sachs
2 questions for CYTK
Roanna Clarissa Ruiz
Leerink Partners
2 questions for CYTK
Srikripa Devarakonda
Truist Financial Corporation
2 questions for CYTK
Ashwani Verma
UBS Group AG
1 question for CYTK
Cameron Bozdog
Bank of America
1 question for CYTK
David Lebowitz
Citigroup Inc.
1 question for CYTK
Gena Wang
Barclays
1 question for CYTK
Huidong Wang
Barclays
1 question for CYTK
John Gionco
Needham & Co.
1 question for CYTK
Leland Gershell
Oppenheimer & Co. Inc.
1 question for CYTK
Maxwell Skor
H.C. Wainwright & Co.
1 question for CYTK
Nikola Gasic
Leerink Partners
1 question for CYTK
Phoebe Tan
Jefferies Financial Group Inc.
1 question for CYTK
Rohan Mathur
Oppenheimer & Co. Inc.
1 question for CYTK
Zaki Molvi
Jefferies
1 question for CYTK
Recent press releases and 8-K filings for CYTK.
- Cytokinetics' lead drug, aficamten, has a PDUFA date of December 26 for obstructive HCM (OHCM) in the US, with potential approvals in China in Q4 and EMA early next year.
- The company expects aficamten to offer a differentiated profile and risk mitigation program (REMS) compared to competitors, aiming for wider adoption and increased preference share post-launch.
- The ACACIA study for aficamten in non-obstructive HCM (NHCM) is set for a **Q2 data readout **, potentially leading to a supplemental NDA by the end of next year and a 2027 commercial launch.
- Cytokinetics projects ending the year with over $1 billion, potentially $1.2 billion, in cash, ensuring a strong financial runway.
- Cytokinetics' lead product, aficamten, has a PDUFA date of December 26 for obstructive HCM (OHCM) in the U.S., with anticipated China approval in Q4 and EMA approval early next year.
- The Acacia study for non-obstructive HCM (NHCM) is expected to have data readout in Q2 (next year), with a positive outcome potentially leading to a supplemental NDA by the end of next year and a commercial launch in NHCM in 2027.
- The company expects to end the year with over $1 billion, closer to $1.2 billion in cash, providing a strong cash runway to support its business ambitions.
- Cytokinetics anticipates a differentiated risk mitigation profile for aficamten, potentially leading to a less burdensome REMS program, which could expand prescribing beyond current CMI users and accelerate market penetration.
- While the CMI class has seen consistent patient adds of 10,000 per year, Cytokinetics believes aficamten's entry, supported by Maple data and a differentiated profile, could increase net patient adds for the class and result in more new patients than MAVA by the end of next year.
- Cytokinetics' lead drug, aficamten, has a PDUFA date of December 26 for obstructive HCM, with potential approvals in China in Q4 and EMA early next year.
- The Acacia study for non-obstructive HCM is expected to read out data in Q2, potentially leading to a supplemental NDA by the end of next year and a commercial launch in 2027 if positive.
- The company anticipates ending the year with a strong cash position, north of $1 billion, closer to $1.2 billion.
- Cytokinetics expects a potentially faster launch for aficamten than Camzyos due to a differentiated risk mitigation profile (REMS) and product characteristics, with commercial reimbursement projected to cover 70-75% of commercial lives by the latter half of next year.
- Cytokinetics is preparing for the potential launch of Aficamten, a cardiac myosin modulator, with U.S. FDA approval anticipated later this year. Parallel reviews are underway in China and Europe, with a potential launch in Germany in the first half of next year.
- The company expects to end 2025 with over $1 billion in cash and cash equivalents, and projects a strong balance sheet with $1.2 billion in cash and investments by year-end. Cytokinetics also has access to additional capital, including a potential $175 million Tranche 7 loan from Royalty Pharma.
- Aficamten has shown positive results in two Phase 3 studies (Sequoia and Maple) for obstructive hypertrophic cardiomyopathy (OHCM). The company is optimistic about the upcoming Acacia Phase 3 study results for non-obstructive HCM (NHCM) in Q2 2026, which could further expand Aficamten's market.
- Cytokinetics aims for Aficamten to have a differentiated risk mitigation profile (REMS) and greater flexibility in dosing compared to competitors, which they believe will facilitate broader prescriber adoption.
- Bragar Eagel & Squire, P.C. reminds investors of a class action lawsuit against Cytokinetics, Incorporated (NASDAQ:CYTK).
- The lawsuit covers a Class Period from December 27, 2023, to May 6, 2025, with a Lead Plaintiff Deadline of November 17, 2025.
- The complaint alleges that Cytokinetics made materially false and misleading statements regarding the timeline for the New Drug Application (NDA) submission and approval process for aficamten, specifically by failing to disclose risks related to submitting the NDA without a Risk Evaluation and Mitigation Strategy (REMS).
- A class action lawsuit has been filed against Cytokinetics, Incorporated (NASDAQ: CYTK) for alleged materially false and/or misleading statements during the class period of December 27, 2023 – May 6, 2025.
- The complaint alleges that the company failed to disclose the omission of a REMS from its initial NDA submission, which necessitated a three-month delay in the FDA's potential approval process.
- Investors have until November 17, 2025, to file a lead plaintiff motion in this class action.
- Cytokinetics announced additional positive data from the MAPLE-HCM trial for its investigational drug, aficamten, demonstrating superiority over metoprolol in exercise capacity, symptoms, and cardiac biomarkers for hypertrophic cardiomyopathy (HCM).
- A pre-specified responder analysis showed that 78% of patients on aficamten achieved a positive or complete response across five clinical parameters, significantly outperforming 3% of patients on metoprolol.
- Patients treated with aficamten demonstrated significantly greater improvements in patient-reported outcomes, with 38.6% reporting very large improvements in KCCQ-OSS compared to 18.4% for metoprolol.
- Aficamten was associated with a 73% reduction in NT-proBNP and a 43% reduction in hs-cTnI, indicating significant improvement in cardiac biomarkers.
- Aficamten is currently under regulatory review by the FDA with a PDUFA target action date of December 26, 2025, and also by the EMA and NMPA.
- Faruqi & Faruqi, LLP is investigating potential claims against Cytokinetics, Incorporated (NASDAQ: CYTK) and has filed a federal securities class action.
- The lawsuit alleges that defendants made materially false and misleading statements regarding the New Drug Application (NDA) submission and approval process for aficamten, including the expected FDA approval timeline and the failure to disclose risks related to not submitting a Risk Evaluation and Mitigation Strategy (REMS).
- Investors who purchased or acquired securities in Cytokinetics between December 27, 2023, and May 6, 2025, are encouraged to contact Faruqi & Faruqi to discuss their legal rights.
- The deadline for investors to seek the role of lead plaintiff in the class action is November 17, 2025.
- Cytokinetics reported doubled losses in Q3 2025 and revenues significantly below expectations, with investor focus remaining on the December 26, 2025, FDA decision for its cardiovascular drug, Aficamten.
- The company is facing a federal securities class action lawsuit alleging misleading statements regarding the Aficamten NDA submission, specifically the omission of a Risk Evaluation and Mitigation Strategy (REMS) that could delay regulatory approval.
- Investors who purchased stock during the class period are encouraged to consider legal action before the November 17, 2025, deadline to serve as lead plaintiff.
- Despite financial and legal concerns, HC Wainwright maintains a buy recommendation and a $120 price target for Cytokinetics, projecting a loss of $5.75 per share for 2025.
- Faruqi & Faruqi, LLP is investigating potential securities law violations at Cytokinetics, Incorporated.
- The investigation follows the FDA's three-month extension of the review period for Cytokinetics' heart drug aficamten on May 1, 2025.
- Cytokinetics admitted it initially filed its New Drug Application (NDA) without a Risk Evaluation and Mitigation Strategy (REMS), despite prior discussions with the FDA about safety and risk mitigation.
- Following this news, Cytokinetics' stock fell $5.57, or 12.9%, closing at $37.35 per share on May 2, 2025.
Quarterly earnings call transcripts for CYTOKINETICS.
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