BioRestorative Therapies, Inc. (BRTX) announced that it has completed a Type B meeting with the U.S. FDA regarding a potential accelerated Biologics License Application or BLA approval pathway for its Fast-Track-Designated BRTX-100 program in chronic lumbar disc disease or cLDD.
According to the company, FDA did not raise any clinical safety concerns based on consistent positive safety endpoints from BioRestorative's ongoing 99-patient Phase 2 trial of BRTX-100. The agency endorsed the proposed Phase 3 study design, including outcome assessments, dosing strategy, eligibility criteria, sample size, and powering assumptions, pending final review of the Phase 3 investigational new drug application submission.
FDA feedback also confirmed alignment of the company's ongoing Chemistry, Manufacturing and Controls activities prior to submission of the Phase 3 investigational new drug application. Based on the positive official summary of the meeting, BioRestorative has initiated Phase 3 enabling activities, with the goal of submitting the Phase 3 investigational new drug application later in 2026.
The FDA granted Fast Track designation to the BRTX-100 Phase 2 trial in February 2025. This program is designed to facilitate development and expedite review of investigational treatments for serious conditions with significant unmet medical needs. Benefits include early and frequent interactions with the FDA, and stem cell product candidates with Fast Track designation may be eligible for Priority Review and Accelerated BLA Approval.
BRTX-100, BioRestorative's lead cell-based therapeutic, is engineered to target areas of the body with limited blood flow. The ongoing Phase 2 trial is evaluating safety and efficacy in treating cLDD, with 99 subjects enrolled across 15 U.S. clinical sites. Patients were randomized 2:1 to receive either BRTX-100 or placebo.
BioRestorative develops therapeutic products using cell and tissue protocols, primarily involving adult stem cells. Its core clinical programs focus on disc/spine disease and metabolic disorders, alongside a commercial BioCosmeceutical platform.
BRTX has traded between $0.58 and $2.50 over the past year. The stock is currently trading at $0.48, down 23.94%
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