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BrainStorm Cell Therapeutics Prepares Phase 3b ALS Trial

BrainStorm Cell Therapeutics is moving to initiate its Phase 3b ENDURANCE study for the ALS therapy NurOwn, following a Special Protocol Assessment agreement with the FDA. The company reported a net loss of $3.9 million for the second quarter of 2026 as it shifts its leadership team to prioritize regulatory strategy.

Bio & NewsAugust 14, 2026572 reads0

CEO Chaim Lebovits confirmed that the company is finalizing operational requirements to enroll approximately 200 patients in the upcoming trial. The study design includes a 24-week double-blind, placebo-controlled phase followed by an open-label extension, with results intended to support a future Biologics License Application.

To bolster its regulatory and commercial efforts, the company appointed Peter J. Pitts as Executive Chairman. Pitts, a former FDA Associate Commissioner, will oversee daily operations and investor engagement, while longtime Board Chairman Professor Jacob Frenkel transitions to a senior advisor role. Financially, BrainStorm reported cash and cash equivalents of approximately $0.2 million as of June 30, 2026. The company raised $400,000 through private placements in the second quarter, bringing total capital raised in the first half of the year to $2.4 million.

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