BCLI - FDA authorizes further dosing of BrainStorm Cell's NurOwn under expanded access program

BrainStorm Cell Therapeutics (NASDAQ:BCLI) announces plans for a dosing extension of NurOwn for participants who completed the Expanded Access Protocol (EAP). BCLI shares up 6.2% premarket at $3.95. The FDA recommended that BrainStorm submit an EAP protocol amendment to provide additional dosing for these participants. Under the amended EAP protocol, these eligible participants will receive up to 3 additional doses. Data collected from the original EAP treatments informed the decision to move forward with additional doses for participants who completed it. Under the original EAP protocol, participants who completed the Phase 3 NurOwn trial and met specific eligibility criteria had the opportunity to receive 3 doses of NurOwn.

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FDA authorizes further dosing of BrainStorm Cell's NurOwn under expanded access program