BCLI: Advisory Panel Votes Against Recommending Approval of NurOwn®…
NASDAQ:BCLI
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Business Update
Negative Advisory Committee Meeting Outcome for NurOwn
On September 27, 2023, the U.S. Food and Drug Administration (FDA) convened a meeting of the Cellular, Tissue, and Gene Therapies Advisory Committee (AdCom) to review the Biologics License Application (BLA) for BrainStorm Cell Therapeutics, Inc.'s (NASDAQ:BCLI) NurOwn®. Following a full day of discussion, the Committee voted 17-1 that NurOwn did not demonstrate substantial evidence of effectiveness for the treatment of mild to moderate amyotrophic lateral sclerosis (ALS). The FDA will still need to render a decision about whether or not to approve NurOwn on or before the PDUFA date of December 8, 2023, however given the outcome of the AdCom we no longer are anticipating approval of NurOwn at this time.
Conclusion
This is an unfortunate outcome to the AdCom as we believe BrainStorm’s team did what was necessary to help the members of the Advisory Committee understand the totality of the data, however in the end it appeared that committee members had too many questions and there was insufficient time to have all the questions answered. We anticipate the company considering all of its options over the next few weeks before deciding next steps for the NurOwn program. Since we now anticipate that the FDA will not approve NurOwn and we are unsure of how the company plans to proceed, our valuation has been lowered to $0.50.
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