Avalyn Pharma is a clinical‑stage biopharma building an inhaled anti‑fibrotic platform that reformulates approved drugs for direct pulmonary delivery to reduce systemic toxicity and increase lung exposure. Its lead candidate AP01 (inhaled pirfenidone) completed a Phase Ib study and is recruiting a global Phase IIb trial; AP02 (inhaled nintedanib) finished SAD/MAD Phase I studies and is planned for Phase II, and AP03 is advancing IND support toward Phase I as an inhaled fixed‑dose combination. The company emphasizes a “inhaled delivery + local targeting” strategy to improve tolerability and enable combination regimens. AP01 has received FDA Fast Track designation. Avalyn collaborates with the US ILD Collaborative Research Network and university‑affiliated hospitals and is preparing manufacturing and supply‑chain capabilities for commercialization. Financially, the company has completed four financing rounds and raised more than $300 million to date, supporting its clinical and regulatory programs. Avalyn Pharma is a clinical-stage biopharmaceutical company developing targeted inhalation therapies for life‑threatening pulmonary diseases, including pulmonary fibrosis and other interstitial lung diseases (ILD). Its pipeline focuses on new inhaled formulations of approved medicines designed to reduce systemic exposure and deliver medication directly to the site of disease. The company’s lead clinical assets are AP01 (inhaled pirfenidone) and AP02 (inhaled nintedanib). Avalyn plans to advance AP01 into a Phase 2b trial and AP02 into a Phase 2a trial. The company will use proceeds from the financing to continue development of its portfolio of inhalation therapies for ILD and to advance its lead assets into mid-stage clinical trials. Avalyn is led by CEO Lyn Baranowski and is based in Seattle, WA.

Total raised

$275M

Funding rounds

2

Latest round

Series D

Latest activity

Sep 2025