BCLI - BrainStorm shares plunge 25% after FDA feedback on NurOwn program

BrainStorm Cell Therapeutics (BCLI) slumps 25% premarket after receiving FDA feedback on a high-level data summary from the NurOwn (autologous MSC-NTF cells) ALS Phase 3 clinical trial.The FDA has concluded that the current level of clinical data does not provide the threshold of substantial evidence that Agency is seeking to support a Biologics License Application ((BLA)).In addition, the FDA advised that this recommendation does not preclude BCLI from proceeding with a BLA submission.

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BrainStorm shares plunge 25% after FDA feedback on NurOwn program