BrainStorm Cell Therapeutics To Meet With US FDA To Discuss Development Plan For NurOwn As A Treatment Of ALS; Biologics License Application To Be Withdrawn Without Prejudice
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BrainStorm Cell Therapeutics is set to meet with the US FDA to discuss the development plan for NurOwn, a treatment for ALS. The company is withdrawing its Biologics License Application (BLA) for NurOwn, a decision coordinated with and viewed by the FDA as a withdrawal without prejudice. BrainStorm remains committed to the ALS community and is exploring next steps for NurOwn, including publishing emerging clinical data and developing a protocol for an additional clinical study.
October 18, 2023 | 10:03 am
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BrainStorm Cell Therapeutics is withdrawing its Biologics License Application for NurOwn, a treatment for ALS. The company is set to meet with the FDA to discuss the development plan for NurOwn and is exploring next steps, including publishing clinical data and developing a protocol for an additional study.
The withdrawal of the BLA for NurOwn could be seen as a setback, potentially delaying the treatment's approval and launch. However, the company's commitment to continue developing NurOwn and its plans to meet with the FDA to discuss the treatment's development plan suggest that this is a strategic move rather than a sign of failure. The impact on the stock price is uncertain in the short term, as the market may react negatively to the withdrawal of the BLA, but could also react positively to the company's ongoing commitment to NurOwn's development.
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