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id: 860, Created by Polina Foster, Scout
Brainstorm Cell (BCLI) Biologics License Problem Case
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S.D. New YorkCourt
- Brainstorm Cell allegedly downplayed an FDA letter and concealed biologics license application risks.
- In September 2023, the truth came out, leading to a 47% $BCLI fall the next day.
Brainstorm is currently under investigation due to an FDA report, regarding its biologics license application (BLA).
The issues included insufficient scientific evidence, major gaps in information about the treatment's safety and effectiveness, and missing details like proper material control and safety measures.
Additionally, there were concerns about the facilities used to make the treatment, as they weren't ready for inspection.
This news caused $BCLI fall by 47% and $8.42M loss of market cap, damaging shareholders.
Given all the information, investors have reasons to suspect that Brainstorm didn't disclose issues with BLA and the company's treatment's quality and safety.
Failure to Disclose,
Shock Event Date
28 September 2023
01 November 2023
Lead Plaintiff Deadline
02 January 2024