Avalyn Pharma Inc. reports news about its clinical-stage development of inhaled therapies for serious, rare respiratory diseases. Recurring company updates cover AP01 and AP02, pulmonary fibrosis research, clinical presentations, peer-reviewed publications, patient-centered treatment research, and respiratory-disease conference activity.
Company news also includes public-company developments such as the closing of its initial public offering, Nasdaq listing of AVLN common stock, capital-structure updates, governance changes, leadership appointments, clinical or regulatory disclosures, and operating and financial results tied to its rare lung disease pipeline.
Avalyn Pharma (AVLN) reported publication of detailed Phase 1 data for AP02, a nebulized form of nintedanib for idiopathic pulmonary fibrosis (IPF), in the journal Respiratory Research on September 21, 2026.
The two randomized Phase 1 studies tested single ascending AP02 doses up to 2.0 mg in healthy volunteers and IPF patients, and single and multiple ascending doses up to 8.0 mg twice daily for seven days in healthy volunteers, alongside a 150 mg oral nintedanib cohort. AP02 was generally well tolerated with no serious adverse events and no treatment-related withdrawals; common treatment-related events included headache, nausea, mild cough, and dizziness.
Across multiple-dose cohorts, AP02 produced 10- to 56-fold lower systemic exposure than the mean steady-state exposure of the approved 150 mg twice-daily oral dose, while a 4.0 mg AP02 dose achieved about 26-fold higher predicted lung epithelial lining fluid peak concentration and overall exposure than oral nintedanib. These data supported advancement of AP02 into the AURA Phase 2 randomized, double-blind, placebo-controlled trial in IPF, a 12-week study of two twice-daily doses in 160 patients with topline results expected in late 2027.
Avalyn Pharma (AVLN) has appointed Robert (Bob) J. Meyer, MD, a pulmonary physician and former senior U.S. FDA leader, to its Board of Directors.
Dr. Meyer most recently served as Principal of Drug and Biologics Products at Greenleaf Health, now Eliquent Life Sciences, and previously led the Division of Pulmonary and Allergy Drug Products and the Office of Drug Evaluation II at the FDA. He later held senior regulatory and safety leadership roles at Merck Research Laboratories and directed the Virginia Center for Translational and Regulatory Sciences at the University of Virginia School of Medicine.
The company said his clinical, regulatory and governance experience will support development of Avalyn’s inhaled antifibrotic programs AP01, AP02 and AP03 for serious respiratory diseases.
Avalyn Pharma (AVLN) will participate in a fireside chat at the Morgan Stanley 24th Annual Global Healthcare Conference in New York City on September 14, 2026, from 1:50 to 2:25 p.m. ET.
A live webcast and archived recording of the event will be available on the company’s website under the Investor section, on the News & Events page.
Avalyn Pharma (AVLN) presented new in silico and patient survey data on investigational inhaled therapy AP01 in pulmonary fibrosis at ERS 2026.
Using the Ebenbuild Twinhale® in silico modeling platform with three-dimensional lung models from high‑resolution CT scans, simulations combined AP01 eFlow® Nebulizer System characteristics with healthy, mild IPF and severe IPF anatomies. The models predicted broad aerosol distribution throughout the lung, including in severely fibrotic lungs, with consistent deposition patterns across all disease states. Alveolar and thoracic tissues accounted for most deposited aerosol mass, indicating robust delivery to primary sites of fibrotic remodeling and active disease, and video visualization showed deposition with simulated tidal breathing.
A separate survey of individuals living with IPF found strong willingness to participate in clinical research, including long‑distance travel and extended placebo‑controlled studies. Participants highlighted clear communication of goals, risks and potential benefits, recognition of prior patient experience, and efforts to reduce logistical burden as key to supporting engagement and informing more patient‑focused clinical trial design.
Avalyn Pharma (Nasdaq: AVLN) announced two poster presentations at the European Respiratory Society International Congress 2026, held September 5–9, 2026, in Barcelona. On September 7, 2026, posters will cover IPF patient perspectives on clinical trial participation and in silico modeling of AP01 lung aerosol distribution. Presentations will also be accessible on the company’s website.
Avalyn Pharma (Nasdaq: AVLN) reported second quarter 2026 results and pipeline progress, highlighting completion of global enrollment in MIST, its Phase 2b trial of inhaled pirfenidone AP01 in progressive pulmonary fibrosis. The 52-week study overenrolled to 398 patients versus a 375 target, with topline data expected in the second half of 2027.
The AP02 AURA Phase 2 trial in idiopathic pulmonary fibrosis, targeting 160 patients over 12 weeks, has enrollment on track, with topline data anticipated in late 2027. A Phase 1 study of AP03, an inhaled fixed-dose combination of pirfenidone and nintedanib, is planned to start by year-end 2026.
As of June 30, 2026, Avalyn held $413.5 million in cash, cash equivalents and marketable securities, including approximately $316.6 million of IPO net proceeds, which is projected to fund operations into 2029. Second quarter 2026 R&D expenses were $24.7 million and G&A expenses were $6.6 million, leading to a net loss of $28.9 million.
Avalyn (Nasdaq: AVLN) completed target enrollment of 375 patients in its global Phase 2b MIST trial of AP01 (inhaled pirfenidone) for progressive pulmonary fibrosis (PPF). The randomized, double-blind, placebo-controlled study will assess lung function over 52 weeks, with topline 12‑month results expected in the second half of 2027.
Avalyn (Nasdaq: AVLN) reported Q1 2026 results and pipeline progress. Cash, cash equivalents, and marketable securities were $123.1 million on March 31, 2026, excluding IPO proceeds. An upsized IPO raised $345.0 million, with total liquidity projected to fund operations into 2029.
MIST Phase 2b AP01 enrollment is on track to complete mid‑2026, AURA Phase 2 AP02 enrollment is underway with topline data expected in 2027, and AP03 Phase 1 is planned by end‑2026.
Avalyn (Nasdaq: AVLN) will present a company overview at the Jefferies Global Healthcare Conference in New York on June 4, 2026, from 9:55–10:25 a.m. ET. A live webcast and archived recording will be available on Avalyn’s investor relations website.
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.