FDA Events for Pulmonx (LUNG)
This section highlights FDA-related milestones and regulatory updates for drugs developed by Pulmonx (LUNG).
Over the past two years, Pulmonx has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
AeriSeal. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
AeriSeal - FDA Regulatory Timeline and Events
AeriSeal is a drug developed by Pulmonx for the following indication: For bronchoscopic lung volume reduction (BLVR) and block collateral ventilation.
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:
- AeriSeal
- Announced Date:
- September 9, 2024
- Indication:
- For bronchoscopic lung volume reduction (BLVR) and block collateral ventilation.
Announcement
Pulmonx Corporation announced the presentation of clinical data from the AeriSeal® CONVERT trial and 5-year follow-up data from the LIBERATE study at the European Respiratory Society (ERS) Congress in Vienna, Austria.
AI Summary
Pulmonx Corporation recently announced that it will present groundbreaking clinical data at the European Respiratory Society (ERS) Congress in Vienna, Austria. The company is sharing results from the AeriSeal® CONVERT trial, which demonstrated that the AeriSeal System is safe and effective for patients with severe emphysema and collateral ventilation. In the trial, 77.6% of patients converted from having collateral ventilation (CV+) to minimal or no collateral ventilation (CV-), making them eligible for treatment with Zephyr® Endobronchial Valves.
Additionally, Pulmonx will show 5-year follow-up data from the LIBERATE study that highlights durable improvements in lung function and quality of life for patients treated with Zephyr® Valves. These long-term benefits emphasize the value of minimally invasive lung volume reduction therapies. Overall, the data strengthen Pulmonx’s commitment to advancing innovative treatments for severe lung disease.
Read Announcement
Pulmonx FDA Events - Frequently Asked Questions
As of now, Pulmonx (LUNG) has not received any FDA approvals for its therapy in the last two years.
In the past two years, Pulmonx (LUNG) has reported FDA regulatory activity for AeriSeal.
The most recent FDA-related event for Pulmonx occurred on September 9, 2024, involving AeriSeal. The update was categorized as "Data Presentation," with the company reporting: "Pulmonx Corporation announced the presentation of clinical data from the AeriSeal® CONVERT trial and 5-year follow-up data from the LIBERATE study at the European Respiratory Society (ERS) Congress in Vienna, Austria."
Currently, Pulmonx has one therapy (AeriSeal) targeting the following condition: For bronchoscopic lung volume reduction (BLVR) and block collateral ventilation..
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:LUNG) was last updated on 7/11/2025 by MarketBeat.com Staff
