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.
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.
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.
Comments (0)
No comments yet. Be the first!