PRNewsWire
28 May 2026, 11:45 UTC · 2h ago
Source · https://www.prnewswire.com/news-releases/brainstorm-cell-therapeutics-appoints-former-fda-associate-commissioner-peter-j-pitts-to-board-of-directors-302784278.html
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BrainStorm Cell Therapeutics has secured a first-of-its-kind FDA Special Protocol Assessment (SPA) for its Phase 3b ENDURANCE trial of NurOwn for ALS. — An SPA reduces regulatory risk by providing FDA agreement on trial design before initiation, significantly increasing the probability of a successful path to approval.
+0.60The initiation of the Phase 3b ENDURANCE trial is contingent upon the acquisition of necessary funding. — This indicates a capital shortfall that may lead to dilutive financing or delays in the company's primary clinical catalyst.
-0.40Former FDA Associate Commissioner Peter J. Pitts has joined BrainStorm's Board of Directors. — Adding a high-level former regulator provides the company with strategic guidance and credibility during critical FDA interactions.
+0.30Ticker attribution
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The company appointed a high-profile former FDA official to its board and is preparing to launch a historic Phase 3b trial under a unique Special Protocol Assessment.
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