HomeMarket NewsFDA advisory panel votes against BrainStorm ALS therapy

FDA advisory panel votes against BrainStorm ALS therapy

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Iryna Drozd

The FDA advisory panel voted against BrainStorm Cell Therapeutics’ NurOwn therapy for the treatment of mild-to-moderate ALS, stating that the data did not demonstrate substantial effectiveness.

The panel’s vote resulted in 17 against and 1 abstention. While the FDA is not legally obliged to follow the panel’s recommendations, it generally does. The FDA is expected to make a final decision on the approval of NurOwn for ALS treatment by December 8.

Shares of BrainStorm were halted on Wednesday in anticipation of the panel’s vote and remained halted during after-hours trading.

The stock price of BrainStorm experienced a significant drop earlier this week following concerns raised by FDA reviewers about the drug’s effectiveness.

In a Phase 3 trial, NurOwn did not meet its primary and secondary endpoints. BrainStorm claims that this outcome may be attributed to a β€œfloor effect,” which can complicate the measurement of disease progression in advanced-stage patients. However, subsequent analysis of the data revealed clinically meaningful effectiveness in patients with less advanced disease.

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