Former FDA Official Joins BrainStorm Board Ahead of Historic ALS Trial
Written by Emily J. Thompson, Senior Investment Analyst
Updated: 3 days ago
0mins
Source: PRnewswire
- New Board Member: BrainStorm Cell Therapeutics Inc. has appointed former FDA Associate Commissioner Peter J. Pitts to its Board of Directors, whose extensive experience in healthcare policy and regulatory science will significantly support the company's innovations in ALS treatment.
- Historic Trial Launch: BrainStorm plans to initiate its Phase 3b ENDURANCE trial evaluating NurOwn® for ALS upon securing necessary funding, with this trial being the first to receive FDA Special Protocol Assessment (SPA), marking a significant advancement in ALS therapeutics.
- Regulatory Innovation Opportunity: Pitts emphasized that the new leadership at the FDA presents greater opportunities for regulatory innovation and scientific engagement, particularly in the urgent context of ALS patients needing effective treatments, highlighting the focus on patient urgency.
- Clinical Research Insights: BrainStorm's NurOwn® platform has completed a Phase 3 trial in ALS and is set to launch a second Phase 3b trial under the FDA's SPA agreement, further advancing the understanding of ALS biology and the development of treatment strategies.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
