This section highlights FDA-related milestones and regulatory updates for drugs developed by Avalyn Pharma (AVLN).
Over the past two years, Avalyn Pharma has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
AP02 and AP01. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
AP02 FDA Regulatory Events
AP02 is a drug developed by Avalyn Pharma for the following indication: In Healthy Volunteers And Patients With IPF.
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:
- AP02
- Announced Date:
- September 21, 2026
- Indication:
- In Healthy Volunteers And Patients With IPF
Announcement
Avalyn Pharma Inc., announced that Respiratory Research has published detailed results from two Phase 1 clinical trials of AP02 (nebulized nintedanib) in healthy volunteers and patients with IPF.
Read Announcement
AP01 FDA Regulatory Events
AP01 is a drug developed by Avalyn Pharma for the following indication: Patients with Progressive Pulmonary Fibrosis.
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:
- AP01
- Announced Date:
- September 8, 2026
- Indication:
- Patients with Progressive Pulmonary Fibrosis
Announcement
Avalyn Pharma Inc. announced new data demonstrating predicted aerosol distribution of AP01 and survey data highlighting patient perspectives on participation in clinical studies for idiopathic pulmonary fibrosis (IPF).
Read Announcement- Drug:
- AP01
- Announced Date:
- June 17, 2026
- Indication:
- Patients with Progressive Pulmonary Fibrosis
Announcement
Avalyn Pharma Inc announced that it has completed target enrollment of 375 patients in the Phase 2b MIST clinical trial of AP01 (inhaled pirfenidone) in patients with progressive pulmonary fibrosis (PPF). Additional patients currently in screening remain eligible for randomization and may be enrolled in the trial over the next several weeks.
AI Summary
Avalyn Pharma Inc. said it has reached the planned enrollment target of 375 patients in its Phase 2b MIST clinical trial of AP01, an inhaled form of pirfenidone, for people with progressive pulmonary fibrosis (PPF). The study is testing two doses of AP01 against placebo in a global, randomized, double-blind design.
MIST assigns patients in a 2:1:2 ratio to AP01 100 mg twice daily, AP01 50 mg twice daily, or placebo. The main goal is to see whether AP01 can improve or slow decline in lung function, measured by forced vital capacity, after 52 weeks. Avalyn said patients still in screening may continue to be enrolled over the next several weeks if they remain eligible.
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