Avalyn Pharma is a clinical-stage biopharmaceutical company developing inhaled therapies for pulmonary fibrosis (PF), a progressive lung disease with a median survival of three to five years. The company's core thesis is that the three approved oral antifibrotic therapies — pirfenidone, nintedanib, and nerandomilast — cause significant GI side effects due to systemic exposure, leading roughly half of patients to discontinue treatment within a year. Avalyn reformulates the same active ingredients as inhaled therapies delivered directly to the lungs, aiming to improve both tolerability and efficacy. The pipeline has three candidates: AP01 (inhaled pirfenidone) is in a Phase 2b trial targeting progressive PF, with topline data expected in 2H 2027; AP02 (inhaled nintedanib) is in a Phase 2 trial targeting IPF, with data also expected late 2027; and AP03, an inhaled fixed-dose combination of both drugs, is in preclinical development with Phase 1 planned for late 2026. Avalyn holds an exclusive license to PARI's eFlow nebulizer system for these formulations, and its patent portfolio extends to 2043 on certain programs, which the company argues creates meaningful barriers to competitive entry. Avalyn has no marketed products and no revenue. The company plans to use the Section 505(b)(2) NDA pathway, which allows reliance on the FDA's prior findings for the oral versions of these drugs, potentially reducing the clinical evidence burden for approval.