Avalyn Pharma Secures $100M Series D Funding to Advance Inhaled Pulmonary Fibrosis Treatments

Avalyn Pharma, a Cambridge, Massachusetts-based biopharmaceutical company, has successfully raised $100 million in an oversubscribed Series D financing round. The funding, led by Suvretta Capital Management and SR One, will accelerate the development of novel inhaled formulations of approved drugs for pulmonary fibrosis, a devastating lung condition affecting hundreds of thousands of patients in the United States alone.

Innovative Approach to Pulmonary Fibrosis Treatment

Avalyn's pipeline focuses on reformulating two widely used oral medications for pulmonary fibrosis—pirfenidone and nintedanib—into inhaled versions. The company's lead candidates, AP01 and AP02, are inhaled formulations of pirfenidone and nintedanib, respectively.

CEO Lyn Baranowski explained the rationale behind this approach: "Pulmonary fibrosis is one of 200 forms of interstitial lung diseases. And only a handful have anything approved for treatment." She added, "Between the two types of pulmonary fibrosis, it's 300,000 patients in the U.S. But only 30% of patients are taking either of the oral meds at any one time, despite it being deadly. What's wrong with the drugs? It's that they make you feel terrible."

By delivering these medications directly to the lungs, Avalyn aims to enhance efficacy while significantly reducing systemic side effects associated with oral administration, such as severe gastrointestinal issues.

Clinical Progress and Future Plans

AP01, Avalyn's inhaled version of pirfenidone, is currently being evaluated in a global Phase 2b study called MIST. The trial, expected to enroll 300 participants with progressive pulmonary fibrosis, has a primary readout scheduled for April 2026. An ongoing open-label extension of a Phase 1b trial has demonstrated safety and efficacy for AP01 over more than four years.

AP02, the inhaled formulation of nintedanib, recently showcased favorable tolerability and safety data from its Phase I trial at the American Thoracic Society 2025 conference. The company plans to advance AP02 into Phase II trials for idiopathic pulmonary fibrosis (IPF).

Avalyn is also developing AP03, a next-generation inhaled fixed-dose combination of AP01 and AP02. This innovative approach aims to overcome the limitations of combining oral therapies, which has not been possible due to additive side effects. Preclinical studies for AP03 are currently underway.

Financial Backing and Industry Support

The latest $100 million Series D funding brings Avalyn's total financing to over $300 million since its inception in 2015. Previous rounds include a $62 million Series A in 2017, a $35 million Series B in 2020, and a $175 million Series C in 2023.

The current round saw participation from 18 investors, including Novo Holdings, Surveyor Capital (a Citadel LLC affiliate), and other prominent financial institutions. As part of the financing, David Friedman, Managing Director at Suvretta Capital Management, has joined Avalyn's board of directors.

Baranowski commented on the significance of this funding: "Completing a significant round of financing despite the challenging market conditions is a testament to our innovative approach to developing potentially life-saving medicines for patients with pulmonary fibrosis."