BioRestorative Therapies, Inc. reported that it completed enrollment in February 2026 of 99 patients across 15 U.S. sites in its Phase 2 trial of BRTX-100 for chronic lumbar disc disease. The company said it held an FDA Type B meeting and confirmed alignment on its proposed Phase 3 trial design, endpoints, dosing strategy, sample size and powering assumptions, with no safety concerns raised and its CMC framework deemed appropriate for late-stage development. BioRestorative stated it is targeting submission of a Phase 3 IND amendment in the second half of 2026 and expects to report Phase 2 topline results in early 2027. The company also said it strengthened its balance sheet with a $5 million public offering and received patent allowance in Australia related to its ThermoStem platform covering three-dimensional brown adipose-derived stem cell aggregates.

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