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

- Faruqi & Faruqi, LLP is investigating potential claims against **Cytokinetics** and reminds investors of the **November 17, 2025 deadline** to seek the role of lead plaintiff in a federal securities class action.  **[1061983_20250924NY81630:0]** 
- 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_20250924NY81630:0]** 
- Specifically, the company allegedly failed to disclose material risks related to its failure to submit a **Risk Evaluation and Mitigation Strategy (REMS)**, which could delay the regulatory process.  **[1061983_20250924NY81630:0]** 
- This alleged omission led to investors purchasing Cytokinetics' common stock at artificially inflated prices and suffering significant losses when the truth was revealed on **May 6, 2025**, during an earnings call.  **[1061983_20250924NY81630:0]** 
- Investors who suffered losses exceeding **$75,000** in Cytokinetics between **December 27, 2023, and May 6, 2025**, are encouraged to contact Faruqi & Faruqi.  **[1061983_20250924NY81630:0]**

Cytokinetics Faces Federal Securities Class Action

- Cytokinetics, Incorporated participated in a Late Cycle Meeting with the FDA on **September 15, 2025**, regarding its New Drug Application (NDA) for **aficamten in obstructive hypertrophic cardiomyopathy (oHCM)**, and continues to expect a differentiated label and risk mitigation profile if approved.  **[1061983_0001193125-25-204991_d66361d8k.htm:1]** 
- The **Prescription Drug User Fee Act (PDUFA) target action date for aficamten remains December 26, 2025**.  **[1061983_0001193125-25-204991_d66361d8k.htm:1]** 
- The company intends to draw the **full $100.0 million of Tranche 5 term loans** under its Development Funding Loan Agreement on or about **October 1, 2025**.  **[1061983_0001193125-25-204991_d66361d8k.htm:1]**

Cytokinetics Updates on Aficamten Regulatory Review and Loan Drawdown

- Cytokinetics presented additional data for **aficamten** at the European Society of Cardiology Congress 2025, demonstrating that it **improves cardiac structure and function compared to metoprolol** and has a **low annual incidence rate of atrial fibrillation (1.5%)**.  **[1061983_657ded3ca5484bbb82dd26c7408bb276_0]** **[1061983_657ded3ca5484bbb82dd26c7408bb276_1]** **[1061983_657ded3ca5484bbb82dd26c7408bb276_2]** 
- An integrated safety analysis confirmed that **aficamten is well-tolerated** with an adverse event profile similar to placebo, showing a low incidence of new-onset atrial fibrillation (1.9%).  **[1061983_657ded3ca5484bbb82dd26c7408bb276_3]** 
- **Aficamten** is currently under regulatory review by the FDA in the U.S., with a **Prescription Drug User Fee Act (PDUFA) target action date of December 26, 2025**.  **[1061983_657ded3ca5484bbb82dd26c7408bb276_0]** **[1061983_657ded3ca5484bbb82dd26c7408bb276_4]**

Cytokinetics Presents Positive Aficamten Clinical Data and Confirms Regulatory Review Timeline

- Cytokinetics announced positive primary results from the Phase 3 MAPLE-HCM clinical trial, demonstrating the superiority of **_aficamten_** over **_metoprolol_** in patients with symptomatic obstructive hypertrophic cardiomyopathy (oHCM).  **[1061983_43b03c6024064d97bc0dfcf9d050ff6e_0]** 
- The trial's primary endpoint showed a statistically significant improvement in exercise capacity, with a least-squares mean difference of **2.3 mL/kg/min** (p<0.0001) in peak oxygen uptake (pVO2) for **_aficamten_** compared to **_metoprolol_** after 24 weeks.  **[1061983_43b03c6024064d97bc0dfcf9d050ff6e_1]** 
- **_Aficamten_** also demonstrated superiority in five of six secondary endpoints, including improvements in functional class and reduced patient symptom burden.  **[1061983_43b03c6024064d97bc0dfcf9d050ff6e_2]** 
- **_Aficamten_** is currently under regulatory review by the U.S. Food and Drug Administration (FDA), with a Prescription Drug User Fee Act (PDUFA) target action date of **December 26, 2025**.  **[1061983_43b03c6024064d97bc0dfcf9d050ff6e_1]** **[1061983_43b03c6024064d97bc0dfcf9d050ff6e_4]**

Cytokinetics announces positive primary results from MAPLE-HCM trial for _aficamten_

CYTOKINETICS (CYTK)