Jason Butler

Salim Syed

Tessa Romero

Cory Kasimov

James Condulis

Leonid Timashev

Mayank Mamtani

Sean McCutcheon

Yasmeen Rahimi

Akash Tewari

Charles Duncan

Jason Zemansky

Joseph Pantginis

Kyuwon Choi

Roanna Clarissa Ruiz

Srikripa Devarakonda

Ashwani Verma

Cameron Bozdog

David Lebowitz

Gena Wang

Huidong Wang

John Gionco

Leland Gershell

Maxwell Skor

Nikola Gasic

Phoebe Tan

Rohan Mathur

Zaki Molvi

- Bragar Eagel & Squire, P.C. has announced a class action lawsuit against Cytokinetics, Incorporated (NASDAQ:CYTK).  **[1061983_cf3b32733868462ca9f55348f60b3560_0]** 
- The lawsuit alleges that defendants made materially false and misleading statements regarding the timeline for the New Drug Application (NDA) submission and approval process for aficamten.  **[1061983_cf3b32733868462ca9f55348f60b3560_0]** 
- Specifically, the complaint states that the company failed to disclose material risks related to its decision to submit the NDA without a Risk Evaluation and Mitigation Strategy (REMS), which could delay regulatory approval.  **[1061983_cf3b32733868462ca9f55348f60b3560_0]** 
- The **Class Period is from December 27, 2023, to May 6, 2025**, and the **Lead Plaintiff Deadline is November 17, 2025**.  **[1061983_cf3b32733868462ca9f55348f60b3560_0]**

Cytokinetics faces class action lawsuit over aficamten NDA timeline

- Faruqi & Faruqi, LLP is investigating **Cytokinetics** (NASDAQ: CYTK) and a federal securities class action has been filed, alleging the company made materially false and misleading statements regarding the New Drug Application (NDA) timeline for **aficamten**.  **[1061983_449cb44f572242ec8ff074bb752a303d_1]** 
- The complaint states that Cytokinetics failed to disclose material risks related to not submitting a Risk Evaluation and Mitigation Strategy (REMS) for aficamten, which was revealed on **May 6, 2025**, misleading investors about the regulatory timeline.  **[1061983_449cb44f572242ec8ff074bb752a303d_1]** 
- Investors who suffered losses between **December 27, 2023, and May 6, 2025**, are encouraged to contact the firm, with a deadline of **November 17, 2025**, to seek the role of lead plaintiff.  **[1061983_449cb44f572242ec8ff074bb752a303d_0]** **[1061983_449cb44f572242ec8ff074bb752a303d_1]**

Cytokinetics Faces Securities Class Action Over Aficamten NDA Timeline

- Cytokinetics, Incorporated (NASDAQ:CYTK) is facing a class action lawsuit concerning alleged materially false and misleading statements regarding the New Drug Application (NDA) submission and approval timeline for its drug, aficamten.  **[1061983_d024c5237a844c80bc4cdcba9df7d831_1]** 
- The lawsuit alleges the company failed to disclose material risks related to not submitting a Risk Evaluation and Mitigation Strategy (REMS), despite representing expected FDA approval in the second half of 2025.  **[1061983_d024c5237a844c80bc4cdcba9df7d831_1]** 
- The **Class Period is from December 27, 2023 to May 6, 2025**, and the **Lead Plaintiff Deadline is November 17, 2025**.  **[1061983_d024c5237a844c80bc4cdcba9df7d831_1]**

Cytokinetics Faces Class Action Lawsuit Over Aficamten NDA Timeline

- The Portnoy Law Firm has announced a class action lawsuit against Cytokinetics, Incorporated, on behalf of investors who purchased securities between **December 27, 2023, and May 6, 2025**.  **[1061983_ae2e4edfa16e49b9a2ca9833c0e105db_0]** 
- The lawsuit stems from issues with the U.S. Food and Drug Administration (FDA) review of Cytokinetics' New Drug Application (NDA) for aficamten, specifically the company's initial decision to submit the NDA without a Risk Evaluation and Mitigation Strategy (REMS).  **[1061983_ae2e4edfa16e49b9a2ca9833c0e105db_0]** 
- This omission led to the FDA extending the Prescription Drug User Fee Act action date for aficamten's NDA from September 26, 2025, to **December 26, 2025**, to review the subsequently submitted REMS.  **[1061983_ae2e4edfa16e49b9a2ca9833c0e105db_0]** 
- Following these disclosures, Cytokinetics' stock price fell **12.98%** on **May 2, 2025**, and an additional **7.36%** on **May 6, 2025**.  **[1061983_ae2e4edfa16e49b9a2ca9833c0e105db_0]**  Investors have until **November 17, 2025**, to file a lead plaintiff motion.  **[1061983_ae2e4edfa16e49b9a2ca9833c0e105db_0]**

Cytokinetics Faces Class Action Lawsuit

- Bragar Eagel & Squire, P.C. has commenced a class action lawsuit against Cytokinetics, Incorporated (NASDAQ:CYTK).  **[1061983_b3c81d18efc54eb4a64b80ae6ce952dd_0]** 
- The lawsuit alleges that Cytokinetics made materially false and misleading statements regarding the timeline for the New Drug Application (NDA) submission and approval process for **aficamten**.  **[1061983_b3c81d18efc54eb4a64b80ae6ce952dd_0]** 
- The company is accused of failing to disclose material risks related to its decision to submit the NDA without a Risk Evaluation and Mitigation Strategy (REMS), which could delay regulatory approval.  **[1061983_b3c81d18efc54eb4a64b80ae6ce952dd_0]** 
- The **Class Period** for the lawsuit is from **December 27, 2023, to May 6, 2025**, and the **Lead Plaintiff Deadline** is **November 17, 2025**.  **[1061983_b3c81d18efc54eb4a64b80ae6ce952dd_0]**

- A class action lawsuit has been commenced against **Cytokinetics, Incorporated (NASDAQ:CYTK)**, with a **Lead Plaintiff Deadline of November 17, 2025**.  **[1061983_8fcf0c7b6d90485f8c782e729642adda_1]** 
- The lawsuit alleges that defendants made **materially false and misleading statements** regarding the timeline for the New Drug Application (NDA) submission and approval process for aficamten.  **[1061983_8fcf0c7b6d90485f8c782e729642adda_1]** 
- Specifically, the complaint states that Cytokinetics failed to disclose material risks related to the **failure to submit a Risk Evaluation and Mitigation Strategy (REMS)**, which could delay the regulatory process.  **[1061983_8fcf0c7b6d90485f8c782e729642adda_1]** 
- This alleged omission misled investors about the regulatory timeline, causing class members to purchase stock at artificially inflated prices and suffer significant losses when the truth was revealed on **May 6, 2025**.  **[1061983_8fcf0c7b6d90485f8c782e729642adda_1]**

- A class action lawsuit has been filed against **Cytokinetics, Incorporated** (NASDAQ: CYTK).  **[1061983_c24f96ef054f4b02998977a0fec7172d_0]** 
- The lawsuit covers a class period from **December 27, 2023**, to **May 6, 2025**.  **[1061983_c24f96ef054f4b02998977a0fec7172d_0]** 
- The complaint alleges that the company failed to disclose the knowing or reckless omission of a REMS from an initial NDA submission, which necessitated a **three-month delay** in the FDA’s potential approval process.  **[1061983_c24f96ef054f4b02998977a0fec7172d_0]** 
- The deadline for investors to file a lead plaintiff motion is **November 17, 2025**.  **[1061983_c24f96ef054f4b02998977a0fec7172d_0]**

Cytokinetics Faces Class Action Lawsuit Over Alleged Misleading Statements

- A class action lawsuit has been filed against **Cytokinetics, Incorporated (NASDAQ:CYTK)**, alleging materially false and misleading statements regarding the timeline for the New Drug Application (NDA) submission and approval process for aficamten.  **[1061983_9811a91ced7a40ae95b771175accc677_0]** 
- The complaint states that the company represented expected FDA approval for aficamten in **H2 2025** with a **September 26, 2025 PDUFA date**, but failed to disclose material risks related to not submitting a Risk Evaluation and Mitigation Strategy (REMS).  **[1061983_9811a91ced7a40ae95b771175accc677_0]** 
- The Class Period for the lawsuit is from **December 27, 2023, to May 6, 2025**, and the Lead Plaintiff Deadline is **November 17, 2025**.  **[1061983_9811a91ced7a40ae95b771175accc677_0]**

- Cytokinetics' lead product, **Aficamten**, a cardiac myosin inhibitor for obstructive hypertrophic cardiomyopathy (OHCM), is pending FDA review with a **PDUFA date of December 26, 2025**.  **[1061983_2162452_1]**  The company anticipates a **differentiated risk mitigation profile** for Aficamten, which is expected to offer flexibility and ease of use.  **[1061983_2162452_3]** 
- The Phase 3 Maple study for Aficamten in OHCM demonstrated encouraging results, outperforming the standard of care.  **[1061983_2162452_2]**  Additionally, the Acacia study for non-obstructive HCM has completed enrollment, with **results expected in the first half of 2026**, representing a significant market expansion opportunity.  **[1061983_2162452_2]** 
- As of June 2025, Cytokinetics reported a **strong financial position** with approximately **$1 billion in cash and cash equivalents** on its balance sheet.  **[1061983_2162452_2]**  This includes access to an additional **$425 million** from a Royalty Pharma deal, and an **upsized $650 million refinancing** of a prior convert subsequent to the quarter-end.  **[1061983_2162452_2]** 
- Cytokinetics aims to expand the overall cardiac myosin inhibitor market and achieve **preferential market share** for Aficamten, potentially within the first year post-approval.  **[1061983_2162452_5]**  This strategy builds on the current market where Mavacamten is projected to exceed **$1 billion in worldwide sales** this calendar year.  **[1061983_2162452_5]**

Cytokinetics Provides Update on Aficamten Regulatory Progress and Financial Position

- Cytokinetics presented additional positive data for **aficamten** from the MAPLE-HCM and FOREST-HCM clinical trials at the Heart Failure Society of America (HFSA) Annual Scientific Meeting 2025.  **[1061983_44fc842b714746b2b91243b38ac51f89_0]** 
- Data from **MAPLE-HCM** showed aficamten was superior to metoprolol in improving peak oxygen uptake (pVO2) by a least squares mean treatment difference of **+2.3 mL/kg/min** (p<0.001) from baseline to Week 24 in obstructive HCM patients.  **[1061983_44fc842b714746b2b91243b38ac51f89_1]** 
- **FOREST-HCM** 96-week analyses in non-obstructive HCM patients demonstrated sustained efficacy and tolerability, with **79%** of patients improving by at least one NYHA Functional Class and **74%** becoming asymptomatic by Week 96.  **[1061983_44fc842b714746b2b91243b38ac51f89_2]** 
- **Aficamten** is currently under regulatory review, with a U.S. FDA PDUFA target action date of **December 26, 2025**.  **[1061983_44fc842b714746b2b91243b38ac51f89_3]**

CYTOKINETICS (CYTK)