FDA Events for Upstream Bio (UPB)
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.
- Drug:
- Verekitug
- Announced Date:
- July 8, 2025
- Indication:
- In Chronic Obstructive Pulmonary Disease (COPD)
Announcement
Upstream Bio, Inc. announced that the first patient has been dosed in the Company's Phase 2 clinical trial evaluating verekitug in patients with COPD, broadening the global development program for verekitug into a third indication.
AI Summary
Upstream Bio, Inc. announced that the first patient has been dosed in its global Phase 2 VENTURE trial evaluating verekitug for COPD, marking a significant step as the drug enters a third indication. Verekitug is a novel antibody that targets the TSLP receptor, which plays a key role in triggering inflammation. The trial is a randomized, double-blind, placebo-controlled study designed to assess both the efficacy and safety of two dosing regimens—100 mg every 12 weeks and 400 mg every 24 weeks—in approximately 670 adults with moderate-to-severe COPD.
This trial expands the company’s efforts beyond its ongoing studies in severe asthma and chronic rhinosinusitis with nasal polyps. Emerging data suggest that targeting TSLP may offer a differentiated approach to treating COPD, potentially reducing the frequency of exacerbations and improving patient outcomes.
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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 July 8, 2025, involving Verekitug. The update was categorized as "Dose Update," with the company reporting: "Upstream Bio, Inc. announced that the first patient has been dosed in the Company's Phase 2 clinical trial evaluating verekitug in patients with COPD, broadening the global development program for verekitug into a third indication."
Currently, Upstream Bio has one therapy (Verekitug) targeting the following condition: In Chronic Obstructive Pulmonary Disease (COPD).
More FDA Event Resources from MarketBeat
FDA Event Stage Terminology & Abbreviation Guide
- 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:UPB) was last updated on 7/12/2025 by MarketBeat.com Staff
