BeyondSpring (BYSI) Stock Surges 5% as New Plinabulin Data Paves Clear Path for Global NSCLC Registration

BeyondSpring's stock just popped 5%—because fresh Plinabulin data just bulldozed a major regulatory hurdle.

The Data That Changed the Game

New clinical results didn't just meet endpoints; they carved a definitive route toward global registration for non-small cell lung cancer (NSCLC). This isn't incremental progress—it's the kind of validation that makes regulators sit up and take notes.

Why the Market Reacted

A 5% surge in a single session tells you everything. Investors aren't betting on hope; they're pricing in a streamlined path to a multi-billion dollar market. The data provides the ammunition needed for submissions, turning regulatory conversations from 'if' into 'when'.

The Road Ahead

With the clinical case strengthening, the focus shifts from proving efficacy to navigating approval logistics. The company now has what every biotech craves: a clear, data-backed narrative for global health authorities.

For a sector where 'promising data' often leads to sideways trading, a decisive stock move is a rare beast. It suggests the street sees a real asset, not just another science experiment—a refreshing change in a world of overhyped pipelines.

TLDR:

• BYSI Stock Surges 5.28%: Plinabulin Shows Strong Survival Benefit in NSCLC

• BeyondSpring’s Plinabulin Data Boosts NSCLC Treatment Hope, Stock Gains 5.3

• Plinabulin’s Phase 3 Results Strengthen BYSI’s Case for Global NSCLC Approval

• BYSI Stock Jumps 5.28% After Promising NSCLC Trial Results at ESMO Asia
• BeyondSpring Shows Survival Benefit with Plinabulin in NSCLC, Stock Soars

BeyondSpring Inc. (BYSI) saw a notable increase in its stock price, surging by 5.28%, after announcing promising results from its Phase 3 DUBLIN-3 trial.

BeyondSpring Inc., BYSI

The trial evaluated the combination of Plinabulin and docetaxel against docetaxel alone for treating second- and third-line EGFR wild-type non-small cell lung cancer (NSCLC). These results, presented at ESMO Asia 2025, revealed a significant survival benefit for patients using the Plinabulin combination, boosting market confidence and increasing the company’s stock to $2.1150.

Strong Results from the DUBLIN-3 Trial’s Asian Subset

In the Phase 3 DUBLIN-3 trial, the combination of Plinabulin and docetaxel showed a median overall survival (OS) of 10.8 months, compared to 8.8 months with docetaxel alone. The combination’s survival benefi-t was statistically significant with a hazard ratio (HR) of 0.81, meeting the primary endpoint (p=0.0426). This result supports the potential of Plinabulin to improve survival rates for patients with EGFR wild-type NSCLC, signaling a breakthrough in treatment options for this challenging condition.

Further analysis of the non-squamous subgroup showed even more favorable results. For this group, the hazard ratio was 0.69, which translates to a three-month median OS benefit (p=0.0064). These findings reinforce the targeted mechanism of Plinabulin, highlighting its potential to improve survival, especially for patients whose disease biology aligns with the drug’s immune-modulating properties.

Plinabulin also demonstrated a clear safety advantage over docetaxel. The combination therapy significantly reduced the incidence of docetaxel-induced grade 4 neutropenia, with only 3.9% of patients affected compared to 26.5% in the docetaxel-only group (p

Plinabulin’s Mechanism and Future Prospects

Plinabulin, a first-in-class immune-modulating agent, works by targeting dendritic-cell maturation and tumor vasculature. The drug has already shown durable anti-cancer benefits and good tolerability in over 700 patients across various clinical studies. The combination of Plinabulin and docetaxel offers a novel treatment approach, improving survival rates while reducing chemotherapy-induced side effects.

BeyondSpring’s management is confident that the promising data from the DUBLIN-3 trial will support Plinabulin’s global registration for NSCLC. The company plans to advance Plinabulin through a global Phase 3 confirmatory study, aiming to expand its use beyond the Asian market. This study will be a critical step toward positioning Plinabulin as a standard-of-care treatment for NSCLC, especially for patients with EGFR wild-type mutations.