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

Rhea-AI Summary

Avalyn (Nasdaq: AVLN) announced an upcoming EULAR 2026 poster on AP01, inhaled pirfenidone, for progressive pulmonary fibrosis. Updated ATLAS open-label extension data will describe the long-term tolerability profile of AP01 at up to four years of treatment.

The poster, POS1150, will be presented June 6, 2026, in London and made available on Avalyn’s website.

AI-generated analysis. Not financial advice.

Key Figures

Treatment duration: up to four years Conference dates: June 3-6, 2026 Poster session time: June 6, 10:15 BST +1 more

4 metrics

Treatment duration up to four years ATLAS open-label extension trial for AP01

Conference dates June 3-6, 2026 EULAR 2026 in London

Poster session time June 6, 10:15 BST Poster View VIII at EULAR 2026

Poster ID POS1150 EULAR 2026 poster on AP01 4-year data

Market Reality Check

Price: $28.03 Vol: Volume 181,010 is below t...

low vol

$28.03 Last Close

Volume Volume 181,010 is below the 20-day average of 795,619, at a relative level of 0.23x. low

Technical Shares at $28.03 are trading slightly below the 200-day MA of $28.76 and 13.02% below the 52-week high.

Peers on Argus

No peer stocks were flagged in the momentum scanner, suggesting today’s modest -...

No peer stocks were flagged in the momentum scanner, suggesting today’s modest -0.28% move was driven more by company-specific factors than by a broader biotechnology or healthcare rotation.

Historical Context

3 past events · Latest: May 05 (Positive)

Pattern 3 events

Date	Event	Sentiment	Move	Catalyst
May 05	Scientific conference update	Positive	+1.0%	Patient-centered AP01 research posters at ATS 2026 conference.
May 03	Peer M&A, IPO mention	Neutral	-2.6%	Article highlighting venture investors’ track record and Avalyn IPO inclusion.
May 01	IPO completion	Positive	-2.6%	Closing of IPO and underwriters’ option, raising gross proceeds for Avalyn.

Pattern Detected

Post-IPO, Avalyn has shown modest single-day moves around news, with scientific updates aligning with small gains and the IPO close drawing a negative reaction despite being a capital-raising milestone.

Recent Company History

Recent news for Avalyn centers on its IPO and scientific visibility for AP01. On May 1, 2026, the company closed its IPO and overallotment, raising $345 million, but the stock fell 2.58%. A May 5 announcement about patient-centered AP01 research at ATS 2026 coincided with a 1.02% gain. A separate May 3 item highlighted Avalyn’s IPO in the context of broader venture-backed M&A and offerings. Today’s EULAR poster notice continues the pattern of conference-focused updates on AP01.

Market Pulse Summary

This announcement highlights new 4-year tolerability data for AP01 in progressive pulmonary fibrosis...

Analysis

This announcement highlights new 4-year tolerability data for AP01 in progressive pulmonary fibrosis, to be presented at EULAR 2026. It extends Avalyn’s recent series of conference-focused updates following its May 1, 2026 IPO and prior AP01 presentations at ATS 2026. Investors may track how these long-term findings complement earlier patient-centered research, as well as future data on efficacy and broader safety. Key watchpoints include additional clinical readouts, regulatory milestones, and how the program evolves across interstitial lung disease subtypes.

Key Terms

open-label extension trial, progressive pulmonary fibrosis, nebulized pirfenidone, interstitial lung diseases

4 terms

open-label extension trial medical

"Updated findings from the ATLAS open-label extension trial will highlight..."

An open-label extension trial is a follow-up study where participants who finished an earlier clinical trial keep taking the experimental treatment and both they and the researchers know what drug is being given. It lets companies collect longer-term safety and effectiveness information that shorter, blinded trials may not capture. For investors, results from these extensions are like getting additional product testing and user feedback over time, which can reduce uncertainty about future approval, market acceptance, and potential liabilities.

progressive pulmonary fibrosis medical

"...among the cohort of patients with progressive pulmonary fibrosis at up to..."

Progressive pulmonary fibrosis is a condition where lung tissue becomes increasingly scarred and stiff over time, reducing the lungs’ ability to move air and exchange oxygen—imagine a once-spongey lung turning into a hardened sponge that can’t expand. It matters to investors because a growing or underserved patient population, ongoing clinical trials, and potential new treatments or diagnostics can drive revenue, regulatory milestones, partnership activity, and share-price volatility in healthcare, biotech, and medical-device companies.

nebulized pirfenidone medical

"Title: Nebulized pirfenidone (AP01) for progressive pulmonary fibrosis..."

Nebulized pirfenidone is the antifibrotic medication pirfenidone reformulated so patients inhale it as a fine mist from a nebulizer, delivering the drug directly to the lungs instead of swallowing a pill. Investors care because inhaled delivery can concentrate treatment where lung scarring occurs, potentially improving effectiveness, lowering whole‑body side effects, and creating new market or regulatory opportunities—like spot‑treating a stain rather than soaking an entire garment.

interstitial lung diseases medical

"...other interstitial lung diseases: 4-year data from the ATLAS open label..."

A group of conditions that cause inflammation or scarring in the lung’s interstitium — the thin, sponge-like support tissue between air sacs — which makes the lungs stiffer and harder to move air. Investors should care because these diseases drive demand for diagnostics, drugs and medical devices, influence clinical-trial and regulatory risk for therapies, and can have substantial long-term healthcare costs that affect company revenue and valuations.

AI-generated analysis. Not financial advice.

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 the EULAR online program for more details. The presentation will also be accessible on the company’s website.

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 trial
Session: Poster View VIII, Saturday, June 6, 10:15 BST. Poster ID: POS1150
Speaker: Prof. Anna-Maria Hoffmann-Vold, Oslo University Hospital and University Hospital Zurich
Authors: Anna-Maria Hoffmann-Vold, Felix Woodhead, Nazia Chaudhuri, Deepthi Nair, Shailendra Menjoge, Hao Bao, Meredith Hart, Howard M. Lazarus, Craig Conoscenti

About Avalyn Pharma
Avalyn 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 visit avalynpharma.com and follow the company on LinkedIn.

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

Media Contact:
Kat Lippincott, Deerfield Group
kat.lippincott@deerfieldgroup.com
media@avalynpharma.com

FAQ

What did Avalyn (Nasdaq: AVLN) announce about AP01 at EULAR 2026?

Avalyn announced an upcoming EULAR 2026 poster with updated long-term tolerability data on AP01, inhaled pirfenidone, in progressive pulmonary fibrosis. According to Avalyn, the ATLAS open-label extension trial provides up to four years of treatment data for this inhaled therapy.

When and where is Avalyn's AP01 poster session at EULAR 2026?

Avalyn’s AP01 poster will be presented at EULAR 2026 in London on Saturday, June 6, 2026, at 10:15 BST. According to Avalyn, the session is part of Poster View VIII and the poster is identified as POS1150.

What is the focus of Avalyn's ATLAS trial data on AP01 for pulmonary fibrosis?

The ATLAS open-label extension trial focuses on the long-term tolerability profile of AP01 in progressive pulmonary fibrosis. According to Avalyn, updated findings cover patients treated for up to four years, including those with connective tissue disease-associated and other interstitial lung diseases.

How can investors access Avalyn's AP01 EULAR 2026 poster presentation?

Investors can access Avalyn’s AP01 EULAR 2026 poster presentation through the company’s website. According to Avalyn, additional logistical information, including session time and poster ID POS1150, is also available via the EULAR 2026 online program for attendees.

Which patients are included in Avalyn's AP01 ATLAS long-term data presented at EULAR 2026?

The AP01 ATLAS long-term data include patients with progressive pulmonary fibrosis, including connective tissue disease-associated and other interstitial lung diseases. According to Avalyn, these patients received nebulized pirfenidone (AP01) for up to four years in the open-label extension trial.