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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) 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 (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.

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Avalyn Pharma (NASDAQ:AVLN – Get Free Report) is one of 222 publicly-traded companies in the “Pharmaceutical Preparations” industry, but how does it compare to its rivals? We will compare Avalyn Pharma to similar companies based on the strength of its risk, dividends, profitability, valuation, institutional ownership, analyst recommendations and earnings. Institutional & Insider Ownership 30.5% [...]

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.