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Upstream Bio (UPB) FDA Approvals

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Upstream Bio's Drug in the FDA Approval Process

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

Verekitug FDA Regulatory Timeline and Events

Verekitug is a drug developed by Upstream Bio for the following indication: In Chronic Obstructive Pulmonary Disease (COPD). 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.

Upstream Bio FDA Events - Frequently Asked Questions

As of now, Upstream Bio (UPB) has not received any FDA approvals for its therapy in the last two years.

In the past two years, Upstream Bio (UPB) has reported FDA regulatory activity for Verekitug.

The most recent FDA-related event for Upstream Bio occurred on May 18, 2026, involving Verekitug. The update was categorized as "New Data," with the company reporting: "Upstream Bio, Inc. today presented new data from the Phase 2 VIBRANT trial evaluating verekitug in participants with chronic rhinosinusitis with nasal polyps (CRSwNP)."

Currently, Upstream Bio has one therapy (Verekitug) targeting the following condition: In Chronic Obstructive Pulmonary Disease (COPD).

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

FDA progress for NASDAQ:UPB last updated on 5/19/2026 by MarketBeat.com Staff. We continuously monitor for new FDA events and market data.
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