Avalyn Pharma Inc. filed for an initial public offering on the Nasdaq Global Market under the ticker symbol AVLN, according to an S-1 registration statement submitted to the US Securities and Exchange Commission on April 8, 2026. The filing did not disclose a price range or the number of shares to be offered.
The Avalyn Pharma initial public offering involves shares of common stock, with listing on the Nasdaq Global Market contingent upon approval. The filing did not disclose total gross proceeds, share count, or a price range. The company has raised approximately USD 389 million in equity capital since its founding in 2011 from investors including Novo Holdings A/S, SR One, F-Prime, Perceptive Xontogeny Venture Funds, Norwest Venture Funds, Eventide Asset Management, Wellington Management, and Vida Ventures, each holding greater than 5% of shares.
The company is developing inhaled antifibrotic therapies for pulmonary fibrosis. Its lead asset, AP01, is an inhaled formulation of pirfenidone in development for progressive pulmonary fibrosis, or PPF. AP02 is an inhaled formulation of nintedanib being evaluated in idiopathic pulmonary fibrosis, or IPF. A third candidate, AP03, is a preclinical inhaled fixed-dose combination of pirfenidone and nintedanib. The filing states that AP01 and AP02 hold FDA Fast Track Designation and FDA Orphan Drug Designation for IPF, and that AP01 also holds Orphan Drug Designation from the European Medicines Agency for IPF.
AP01 was evaluated in ATLAS, a randomized, open-label Phase Ib trial in IPF patients comparing 50 mg once-daily and 100 mg twice-daily dose regimens. The filing states both regimens showed low rates of gastrointestinal toxicities and liver enzyme elevations, and that the high-dose group achieved near stabilization of lung function at 48 weeks as measured by forced vital capacity. An ongoing open-label extension trial enrolling IPF and PPF patients has continued for more than four and a half years, with 23 of 100 initially enrolled patients still receiving treatment, the filing states. Those data supported initiation of MIST, a global, randomized, 52-week Phase 2b trial of AP01 in PPF, with initial data expected in the second half of 2027.