Live News • Jun 18
Avalyn Pharma Stock in Focus as Phase 2b MIST Trial Hits Patient Enrollment Goal Early Avalyn Pharma has completed target enrollment of 375 patients in its Phase 2b MIST trial evaluating AP01, an inhaled form of pirfenidone, for progressive pulmonary fibrosis (PPF).
The MIST trial reached full enrollment ahead of schedule, indicating strong demand from patients and clinicians for additional treatment options in PPF.
Avalyn expects to report topline 12‑month clinical results from the MIST trial in the second half of 2027.
Completion of enrollment in this key Phase 2b study marks an important clinical milestone for Avalyn Pharma, as it moves AP01 further along the development path for patients with progressive pulmonary fibrosis.
Investors will likely focus on the eventual MIST readout timing and any interim updates, while also considering the usual clinical, regulatory, and funding risks that apply to late-stage drug development. Announcement • Jun 17
Avalyn Pharma Inc. Completes Target Enrollment In Phase 2b MIST Trial Of AP01 For Patients With Progressive Pulmonary Fibrosis Avalyn Pharma Inc. 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. MIST is a global, randomized, double-blinded, placebo-controlled Phase 2b clinical trial evaluating the safety and efficacy of two doses of AP01 in patients with PPF. MIST was designed to enroll 375 patients with PPF, randomized 2:1:2 into three cohorts: AP01 100 mg twice-daily, AP01 50 mg twice-daily, and placebo. The primary endpoint is the change from baseline in lung function, as measured by forced vital capacity (FVC), at 52 weeks. Based on data from the ATLAS Phase 1b trial and ongoing open-label extension study, AP01’s tolerability profile may enable patients to remain on treatment longer. AP01 is an optimized formulation of pirfenidone administered using the PARI eRapid Nebulizer System. AP01 is currently in clinical development for the treatment of progressive pulmonary fibrosis. In the ATLAS Phase 1b study comparing 100 mg twice-daily and 50 mg once-daily doses of AP01, results showed low rates of side effects, including gastrointestinal toxicities and liver enzyme elevations, and suggested a trend toward stability in lung function at the higher dose. AP01 is currently being evaluated in the MIST Phase 2b trial in patients with PPF. Live News • Jun 04
Avalyn Pharma Advances Mid-Stage Lung Trials With US$345 Million IPO Funding Avalyn reported first quarter 2026 results and highlighted progress across its inhaled fibrosis programs.
The MIST Phase 2b trial of lead candidate AP01 in progressive pulmonary fibrosis is expected to complete enrollment in mid-2026, supported by favorable long-term clinical data.
Enrollment is ongoing in the AURA Phase 2 trial of AP02 in idiopathic pulmonary fibrosis, with topline data planned by the end of 2027, and the company recently completed an upsized IPO raising about US$345.0 million to fund operations through 2029.
The key takeaway is that Avalyn is now well funded for several years while it advances two mid-stage clinical trials targeting serious lung diseases.
Investors should keep in mind that clinical and regulatory outcomes for AP01 and AP02 remain central risks, since Avalyn’s current value is closely tied to trial progress and eventual approval prospects. 
