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BeyondSpring (BYSI) FDA Events

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FDA Events for BeyondSpring (BYSI)

This section highlights FDA-related milestones and regulatory updates for drugs developed by BeyondSpring (BYSI). Over the past two years, BeyondSpring has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as plinabulin and Plinabulin. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

BeyondSpring's Drugs in FDA Review

plinabulin - FDA Regulatory Timeline and Events

plinabulin is a drug developed by BeyondSpring for the following indication: Patients with non-small cell lung cancer. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

Plinabulin (Trial 103 - DUBLIN-3) - FDA Regulatory Timeline and Events

Plinabulin (Trial 103 - DUBLIN-3) is a drug developed by BeyondSpring for the following indication: Refractory - Non small cell lung cancer (NSCLC). This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

BeyondSpring FDA Events - Frequently Asked Questions

However, the company does has had drugs under review or in active clinical development.

In the past two years, BeyondSpring (BYSI) has reported FDA regulatory activity for the following drugs: plinabulin and Plinabulin (Trial 103 - DUBLIN-3).

The most recent FDA-related event for BeyondSpring occurred on July 7, 2025, involving plinabulin. The update was categorized as "Publication," with the company reporting: "BeyondSpring Inc. announced publication of a human clinical study in Med (Cell Press) demonstrating that Plinabulin, when combined with radiation and a checkpoint inhibitor, induces dendritic cell (DC) maturation and elicits tumor responses in patients across multiple cancer types who had failed prior ICI therapy."

Current therapies from BeyondSpring in review with the FDA target conditions such as:

  • Patients with non-small cell lung cancer - plinabulin
  • Refractory - Non small cell lung cancer (NSCLC) - Plinabulin (Trial 103 - DUBLIN-3)

More FDA Event Resources from MarketBeat

  • NDA: New Drug Application
  • ANDA: Abbreviated New Drug Application
  • sNDA: Supplemental New Drug Application
  • BLA: Biologics License Application
  • sBLA: Supplemental Biologics License Application
  • FDA Approved: Approved by the FDA
  • EMA: European Medicines Agency
  • CE Mark: European Union Certification
  • NMPA: China National Medical Products Administration
  • MHLW: Japanese Ministry of Health
  • FDA Meeting: Consultation with FDA
  • Pre-IND: Pre-Investigational New Drug Meeting
  • Breakthrough Therapy: Special FDA designation for promising therapies
  • Fast Track: Accelerated FDA approval pathway
  • Orphan Drug: Designation for rare disease treatments
  • RPD: Rare Pediatric Disease Designation
  • RMAT: Regenerative Medicine Advanced Therapy
  • DSMB Review: Data Safety Monitoring Board Review
  • IDMC Review: Independent Data Monitoring Committee
  • MAA: MHRA Marketing Authorization Application
  • RTF: Refusal to File (Rejected Application)
  • 510(k): FDA Clearance for Medical Devices
  • Rolling Submission: Staggered regulatory review process

This page (NASDAQ:BYSI) was last updated on 7/10/2025 by MarketBeat.com Staff
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