BeyondSpring Announces FDA Fast Track Designation for Plinabulin in Post-ICI Non-Squamous NSCLC and Strategic Transaction to Advance Global Phase 3 DUBLIN-4 Trial Toward Planned Interim Analysis
FLORHAM PARK, N.J., Sept. 29, 2026 (GLOBE NEWSWIRE) -- BeyondSpring Inc. (NASDAQ: BYSI) (“BeyondSpring” or the “Company”), a clinical-stage company developing innovative therapies for the treatment of cancer and other diseases, today announced that the U.S. Food and Drug Administration (“FDA”) has granted Fast Track designation to Plinabulin and docetaxel for the treatment of patients with advanced or metastatic non-squamous non-small cell lung cancer (“NSCLC”) without actionable genomic alterations (AGAs) whose disease has progressed following prior anti-PD-(L)1 antibody therapy and platinum-based chemotherapy, representing patients in the second- or third-line treatment setting. This is the patient population being studied in BeyondSpring’s global Phase 3 DUBLIN-4 trial.