Avalyn Pharma Inc. AVLN
Avalyn Pharma Inc. (Nasdaq: AVLN) is a respiratory drug developer. Its lead program, AP01 (inhaled pirfenidone), is in Phase 2 for Progressive pulmonary fibrosis (PPF). Its next catalyst on record is AP03: Phase 1 study initiation (2026).
Upcoming catalysts
No catalyst is dated to the next 30 days or to an FDA action date.
Next further out: AP03 — Phase 1 study initiation (2026). 3 catalysts on record beyond the next 30 days; subscribers see each with its filing sentence.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| AP01 (inhaled pirfenidone) | Progressive pulmonary fibrosis | small molecule | Phase 2 |
| AP02 (inhaled nintedanib) | Idiopathic pulmonary fibrosis | small molecule | Phase 2 |
| AP03 (inhaled pirfenidone + nintedanib fixed-dose combination) | Pulmonary fibrosis | small molecule | Pre-clinical |
Recent results and decisions
- Aug 12, 2026completed enrollment MIST Phase 2b enrollment complete: 398 patients randomized, above the 375 target.
The study overenrolled beyond its target enrollment of 375, with a total of 398 patients randomized into three treatment cohorts.
Filing - Jun 3, 2026positive Long-term open-label data at 4 years: AP01 generally well tolerated in PPF, with favorable FVC trend to 48 months vs published data (not designed for efficacy).
Study results indicate that after four years, AP01 remains generally well tolerated in these patients with PPF, with an adverse event profile consistent with that observed in the ATLAS Phase 1b trial.
Filing - Jun 3, 2026started First patient dosed in March 2026 in the Phase 2 AURA trial of AP02 (previously announced).
In March 2026, Avalyn announced first patient dosing in its AURA trial of AP02.
Filing
For subscribers
- Cash runway against each catalyst, with the company's own runway statement
- Track record: every Phase 3 readout, FDA decision and guidance slip since 2014
- Expected move for each dated catalyst, from comparable past events
- Phase 2 evidence behind each Phase 3 readout
- Companies on the same target or class
- Full catalyst list with filing sentences, deals, registered trials, Excel export
Other phase 2 respiratory companies
The free Monday brief
Last week's readouts and FDA decisions and the dated catalysts in the week ahead, each with its filing sentence.