Why BrainStorm Cell Therapeutics Shares Are Falling
Portfolio Pulse from Henry Khederian
Shares of BrainStorm Cell Therapeutics Inc (NASDAQ:BCLI) dropped 22.6% to $0.23 after the company discussed a Special Protocol Assessment (SPA) for a Phase 3b trial of NurOwn, its ALS treatment, with the FDA. The SPA is intended to align with FDA requirements for a future marketing application. BrainStorm will follow up with necessary documentation as advised by the FDA. The company views the SPA as a step to mitigate regulatory risks and remains dedicated to providing effective ALS treatments. The FDA's agreement on the SPA does not encompass all trial details but indicates support for key elements of the trial design. BCLI's 52-week trading range is from $27.85 to $54.60.
December 07, 2023 | 7:57 pm
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NEGATIVE IMPACT
BrainStorm Cell Therapeutics' stock fell sharply after the FDA meeting regarding the SPA for its ALS treatment, indicating investor concern over the regulatory pathway ahead.
The significant drop in BrainStorm's stock price suggests that investors may be concerned about the potential challenges and uncertainties associated with the regulatory approval process for NurOwn. Despite the FDA's support for key aspects of the trial design, the lack of a full agreement and the need for further documentation could be perceived as potential roadblocks, leading to negative sentiment in the short term.
CONFIDENCE 90
IMPORTANCE 85
RELEVANCE 100