Iryna Drozd
An FDA advisory panel voted Wednesday evening that data didn’t show BrainStorm Cell Therapeutics’ NurOwn to be substantially effective in treating mild-to-moderate ALS.
The panel voted 17 to 1 against the therapy being shown to be effective. One panelist abstained from the voting.
While the FDA is not bound to the recommendations of its expert panels, it generally follows them. The agency is expected to decide on whether to approve the cell therapy for the treatment of ALS by Dec. 8.
Shares of BrainStorm were halted Wednesday in anticipation of the vote. They remained halted in after-hours trading at around 6:00 p.m. ET.
Shares of BrainStorm plunged Monday after briefing documents for the meeting showed FDA reviewers were concerned about the drug’s effectiveness.
A Phase 3 pivotal trial for NurOwn failed to reach its primary or secondary endpoints, an outcome that the company said was likely due a “floor effect” which can confound measurement of disease progression in patients in more advanced stages of the disease. A subsequent analysis of the data showed evidence of clinically meaningful effectiveness in patients with less advanced disease, according to the company.
