Cytokinetics, Incorporated Under Investigation for Misleading Investors

Core Insights - Cytokinetics is under investigation for potentially misleading investors regarding the regulatory timeline for their drug aficamten, particularly concerning the absence of a Risk Evaluation and Mitigation Strategy (REMS) in their New Drug Application (NDA) [1][2] Company Developments - During a May 6, 2025 earnings call, Cytokinetics disclosed multiple pre-NDA meetings with the FDA but submitted the NDA without a REMS, which misled investors and inflated stock prices [2] - On November 11, 2025, Kaye Edward M. MD, a director at Cytokinetics, sold 5,175 shares at $65.08 each, retaining 9,977 shares [3] - The stock price has fluctuated between $65.33 and $67.98, with a current price of $67.06, reflecting a slight increase of 0.93% or $0.62 [3][4] Market Performance - Cytokinetics has a market capitalization of approximately $7.98 billion, with a trading volume of 813,094 shares [4] - The stock's lowest price in the past year was $29.31, indicating significant volatility [4]