BioRestorative shares surge 16.54% premarket after FDA grants Type B meeting to discuss accelerated BLA pathway for BRTX-100 in chronic lumbar disc disease.

BioRestorative Therapies (NASDAQ:BRTX) surged 16.54% in premarket trading following the announcement of a scheduled FDA Type B meeting to discuss an accelerated Biologics License Application (BLA) approval pathway for its Fast-Track-designated BRTX-100 program targeting chronic lumbar disc disease (cLDD). The meeting, set for mid-December, will review positive safety and efficacy data from ongoing Phase 2 trials, with the company seeking an expedited timeline to initiate Phase 3 trials. The Fast Track designation, granted in February 2025, underscores the therapy’s potential to address a significant unmet medical need, as cLDD lacks effective treatments. The news reinforced investor confidence in the company’s regenerative medicine pipeline and regulatory progress, aligning with the sharp premarket rally.