FDA Grants Fast Track Designation to BeyondSpring’s Lung Cancer Treatment

Key Facts

1The U.S. FDA granted Fast Track designation to BeyondSpring's Plinabulin for the treatment of non-squamous non-small cell lung cancer (NSCLC).

The U.S. FDA granted Fast Track designation to BeyondSpring's Plinabulin for the treatment of non-squamous non-small cell lung cancer (NSCLC). GlobeNewswire reported that the designation applies to Plinabulin in combination with docetaxel for specific advanced lung cancer patients whose disease progressed after prior therapies. This regulatory move is designed to expedite the development and review of drugs that treat serious conditions and fill unmet medical needs.

BYSI closed at $1.12 on September 28, 2026, with the stock trading between a day low of $0.751 and a high of $1.14 during that session. The designation marks a significant milestone for the clinical-stage biotech firm, as recent data indicated improved survival rates in specific patient subgroups compared to docetaxel alone.