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OM.US
id: 992
Outset Medical (OM) FDA Warning Letter Case
N.D. California
Court5:24-cv-06124
Case number08/01/2022
Class period Start08/07/2024
Class period End10/28/2024
Lead Plaintiff motion deadline- $OM stockholders filed a claim against Outset Medical for marketing Tablo products for unapproved uses, which could lead to sales delays and revenue issues.
- After the news on August 7, 2024, $OM dropped by over 68%.
- Outset Medical investors can join this case to be notified about potential recovery.
Case Details:
On July 7, 2023, Outset Medical disclosed that it had received a Warning Letter from the FDA asserting that continuous renal replacement therapy (CRRT) promoted on its website requires prior 510(k) clearance for marketing authorization.
Then, on August 2, 2023, Outset announced a delay in shipping TabloCart due to pending 510(k) clearance. On this news, $OM fell by 10.18% the next day.
After that, on October 12, 2023, Outset announced that an FDA warning letter hurt revenue growth and lowered its 2023 revenue forecast. This caused $OM to drop 50% on October 13, 2023.
On August 7, 2024, Outset Medical missed earnings estimates and cut its 2024 revenue forecast by $39 million.
After that, $OM plummeted 68.5% the next day.
Based on these events, $OM investors filed a claim against Outset Medical, accusing the company of the following:
- Outset Medical marketed Tablo products for unapproved uses, likely needing new FDA approval.
- This risked sales delays and revenue issues.
Considering all the representations, investors suspect Outset Medical marketed Tablo products for unapproved uses, which could lead to sales delays and revenue issues.
Case Status
Lead Plaintiff Submission
Alleged Offence
Misleading Statements,
Failure to Disclose,
Omissions
Suspected Party
Directors,
Management
Security Type
Stocks
Trade Direction
Long
Shock Event Date
07/10/2023
Filing date
08/29/2024
Lead Plaintiff Deadline
10/28/2024
Judge
Hon. Edward J. Davila