Nadunolimab Earns FDA Fast-Track Designation in Metastatic PDAC

BioRestorative reports compelling early data for FDA-Fast-Tracked BRTX-100 for cLDD - BioTuesdays

BioRestorative Therapies (NASDAQ: BRTX) announced the presentation of promising preliminary blinded data from the first 36 subjects in its ongoing Phase 2 clinical trial of BRTX-100, an autologous stem cell therapy for chronic lumbar disc disease (cLDD). This data was shared at the ISSCR 2025 Annual Meeting in Hong Kong by Francisco Silva, VP of Research and Development. The FDA is requiring at least a greater than 30% improvement in function in…

Nadunolimab Earns FDA Fast-Track Designation in Metastatic PDAC

The FDA decision follows phase 2 CANFOUR trial data showing a 2-year survival rate of 35% in IL1RAP-high metastatic pancreatic ductal adenocarcinoma.