BrainStorm Cell Therapeutics saw a 7.2% increase in its shares, reaching 35 cents, following the submission of a special protocol assessment request to the Food and Drug Administration. This request was made for a study exploring the potential treatment for amyotrophic lateral sclerosis. Despite this positive development, the stock has experienced an 85% decline over the past year.

Phase 3b Study of NurOwn

The company, known for its work in adult stem cell therapeutics, submitted the request to the FDA for a Phase 3b study of NurOwn, which is its experimental treatment for amyotrophic lateral sclerosis. BrainStorm Cell Therapeutics anticipates receiving a response from the FDA within 45 days of submission.

Special Protocol Assessment Process

A special protocol assessment involves drug developers meeting with the FDA to establish an agreement on the design and scope of certain clinical trials. This ensures that the trials adequately address scientific and regulatory requirements essential for potentially gaining marketing approval.

“We believe that the SPA will potentially de-risk certain regulatory aspects of the program,” remarked Chief Executive Chaim Lebovits.

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