BCLI: Meeting with FDA to Discuss Development Plan for NurOwn®…
NASDAQ:BCLI
READ THE FULL BCLI RESEARCH REPORT
Business Update
Meeting with the FDA to Discuss Development Plan for NurOwn® in ALS
On October 18, 2023, BrainStorm Cell Therapeutics, Inc. (NASDAQ:BCLI) announced that the U.S. Food and Drug Administration (FDA) has invited the company to request an expedited meeting to discuss the path forward for NurOwn® as a treatment for amyotrophic lateral sclerosis (ALS). The company also announced that it is withdrawing the Biologics License Application (BLA) for NurOwn. This was not a surprising decision following the negative outcome to the Advisory Committee meeting last month and the FDA is viewing it as a withdrawal without prejudice. BrainStorm remains committed to advancing NurOwn as a therapy for ALS, with a registrational Phase 3b trial necessary in order to seek regulatory approval.
Conclusion
We are not surprised by the decision to withdraw the BLA for NurOwn and are encouraged that the FDA has invited BrainStorm to conduct an expedited meeting regarding NurOwn’s development plan. We anticipate details regarding a Phase 3b registrational trial for NurOwn in ALS after the company meets with the FDA, which will also hopefully include details about how the company is planning to finance the trial. We have made no changes to our model and our valuation remains at $0.50.
SUBSCRIBE TO ZACKS SMALL CAP RESEARCH to receive our articles and reports emailed directly to you each morning. Please visit our website for additional information on Zacks SCR.
DISCLOSURE: Zacks SCR has received compensation from the issuer directly, from an investment manager, or from an investor relations consulting firm, engaged by the issuer, for providing research coverage for a period of no less than one year. Research articles, as seen here, are part of the service Zacks SCR provides and Zacks SCR receives quarterly payments totaling a maximum fee of up to $40,000 annually for these services provided to or regarding the issuer. Full Disclaimer HERE.
