Glancy Prongay & Murray LLP Reminds Investors of Looming Deadline in the Class Action Lawsuit Against Outset Medical, Inc. (OM)

Core Viewpoint - Outset Medical, Inc. is facing significant legal and operational challenges following a series of adverse events related to FDA communications and financial performance, leading to a class action lawsuit by investors [1][7]. Group 1: Legal Proceedings - Investors are reminded of the October 28, 2024 deadline to file a lead plaintiff motion in the class action lawsuit concerning Outset Medical securities purchased between August 1, 2022, and August 7, 2024 [1][9]. - The class action alleges that the company made materially false and misleading statements regarding its business operations and failed to disclose adverse facts, particularly concerning the FDA's stance on its Tablo products [7]. Group 2: FDA Warnings and Financial Impact - On July 7, 2023, Outset Medical received a Warning Letter from the FDA, which indicated that certain materials promoted uses outside the approved indications for the Tablo Hemodialysis System, resulting in a stock price drop of $1.20 (5.9%) [3]. - Following a press release on August 2, 2023, announcing a shipment pause for the TabloCart pending 510(k) clearance, the stock price fell by $1.97 (10.18%) [4]. - The company reported on October 12, 2023, that revenue growth was significantly impacted by the FDA's warning letter, leading to a stock price decline of $3.38 (49.9%) [5]. - On August 7, 2024, Outset Medical disclosed second quarter 2024 financial results that missed consensus estimates and lowered its full-year revenue guidance by $39 million, causing a stock price drop of $2.33 (68.53%) [6]. Group 3: Operational Challenges - The company indicated a need for restructuring its sales team and processes to improve execution, which was necessary due to the inability to meet previously forecasted sales ramp for the TabloCart [6].