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Avalyn Announces Additional Long-term Data on AP01, Inhaled Pirfenidone, for the Treatment of Pulmonary Fibrosis to be Presented at the European Alliance of Associations for Rheumatology 2026

Key Takeaway: Avalyn Pharma Inc. announced that it will present updated long-term data on AP01, an inhaled formulation of pirfenidone, at the EULAR 2026 conference. The findings from the ATLAS trial will focus on the drug's tolerability in patients with progressive pulmonary fibrosis over four years. This presentation aims to highlight the potential benefits of inhaled therapies for serious respiratory diseases.
Price reaction · baseline $28.03 (2026-05-20 close) · hit after-hours · 1 other AVLN headline(s) in the window, move may be shared
day 0 close
+1.4%

Market Sentiment Analysis

POSITIVE FACTORS

  • Long-term data indicates improved tolerability of AP01.
  • Presentation at a prominent conference enhances visibility.
  • Encouraging safety and clinical activity noted in trials.

BiopharmaWatch Analysis

From our catalyst data and publicly available data · not financial advice
Cash runway
~40 mo
Minimal dilution risk
Lead asset
AP01
Phase 2 · Pulmonary Fibrosis

Full Press Release Details

BOSTON, May 21, 2026 (GLOBE NEWSWIRE) -- Avalyn Pharma Inc. (Nasdaq: AVLN), a clinical-stage biopharmaceutical company pioneering inhaled therapies to transform the treatment paradigm of serious, rare respiratory diseases, today announced an upcoming poster presentation at the European Alliance of Associations for Rheumatology (EULAR) 2026, being held June 3-6, 2026, in London, England.
Updated findings from the ATLAS open-label extension trial will highlight the long-term tolerability profile of AP01 (inhaled pirfenidone) among the cohort of patients with progressive pulmonary fibrosis at up to four years of treatment. See theEULAR online programfor more details. The presentation will also be accessible on the company’swebsite.

EULAR 2026 Poster Presentation Details:

Title:Nebulized pirfenidone (AP01) for progressive pulmonary fibrosis in connective tissue disease-associated and other interstitial lung diseases: 4-year data from the ATLAS open label extension trialSession: Poster View VIII, Saturday, June 6, 10:15 BST. Poster ID: POS1150Speaker: Prof. Anna-Maria Hoffmann-Vold, Oslo University Hospital and University Hospital ZurichAuthors:Anna-Maria Hoffmann-Vold, Felix Woodhead, Nazia Chaudhuri, Deepthi Nair, Shailendra Menjoge, Hao Bao, Meredith Hart, Howard M. Lazarus, Craig Conoscenti
About Avalyn PharmaAvalyn aims to transform the treatment paradigm for pulmonary fibrosis and other serious, rare respiratory diseases. The company is advancing optimized inhaled formulations of established antifibrotic medicines designed to deliver drug directly to the lungs, enhance local efficacy, and reduce systemic side effects. Avalyn’s AP01 program is an optimized inhaled formulation of pirfenidone currently being evaluated in MIST, a global Phase 2b clinical trial in patients with progressive pulmonary fibrosis (PPF). AP01 has indicated encouraging safety and clinical activity across Phase 1b and multi-year open-label extension trials, with long-term data supporting the potential to preserve lung function while improving tolerability relative to historical oral pirfenidone. Avalyn’s AP02 program is an optimized inhaled formulation of nintedanib currently being evaluated in AURA-IPF, a global Phase 2 clinical trial in patients with idiopathic pulmonary fibrosis (IPF). Avalyn is also advancing AP03, an inhaled fixed-dose combination of pirfenidone and nintedanib, designed to deliver multiple antifibrotic mechanisms through a single lung-targeted platform. By leveraging its proprietary drug-device approach and deep expertise in rare respiratory disease development, Avalyn aims to establish a new standard of care in pulmonary fibrosis through inhaled, lung-targeted therapies. For more information, please visitavalynpharma.comand follow the company onLinkedIn.

Investor Contact:Cassie Saitow, Avalyn Pharma Inc.Sr. Director, IR and Corporate Communicationsir@avalynpharma.com

Media Contact:Kat Lippincott, Deerfield Groupkat.lippincott@deerfieldgroup.commedia@avalynpharma.com

Frequently Asked Questions

What is AP01?

AP01 is an inhaled formulation of pirfenidone designed for treating pulmonary fibrosis.

When will the EULAR 2026 conference take place?

The EULAR 2026 conference will be held from June 3-6, 2026, in London.

What does the ATLAS trial focus on?

The ATLAS trial focuses on the long-term tolerability of AP01 in patients with progressive pulmonary fibrosis.

Who will present the findings at EULAR 2026?

Prof. Anna-Maria Hoffmann-Vold will present the findings at EULAR 2026.

Last updated: May 21, 2026