Avalyn Pharma is developing inhaled versions of antifibrotic medicines, aiming to deliver treatment directly to the lungs in rare, scarring lung diseases.
Boston-based Avalyn Pharma went public in May, closing a larger-than-planned IPO that raised about $345 million before fees and expenses.
Avalyn made its Nasdaq debut under the ticker symbol AVLN after pricing its IPO at $18 per share. The proceeds, together with existing cash, are expected to fund operations into 2029, helping carry the company through expected 2027 trial results across its pulmonary fibrosis drug programs.
Avalyn is focused on rare, scarring lung diseases, starting with pulmonary fibrosis. Pulmonary fibrosis falls within a broader group of lung conditions known as interstitial lung diseases (ILDs), which can involve inflammation, fibrosis or both. In pulmonary fibrosis, lung tissue becomes stiff and scarred, making breathing harder over time.
Current antifibrotic medicines, which are drugs that slow lung scarring, can slow this damage but do not stop or reverse it. Because oral drugs travel throughout the body, some patients may have trouble staying on treatment long term.
Avalyn is developing inhaled versions of these medicines that are delivered directly to the lungs through a fine mist. Avalyn aims to increase drug exposure where it is needed most while reducing exposure across the body that can contribute to side effects.
The company’s programs use PARI’s eRapid Nebulizer System with eFlow Technology. Unlike some inhalers that require a strong, deep breath, nebulized treatments allow patients to breathe in the medicine more naturally. That could be important in pulmonary fibrosis, where chronic cough and reduced lung capacity are common.
Avalyn’s lead candidate, AP01, is an inhaled formulation of pirfenidone being studied for progressive pulmonary fibrosis (PPF). PPF refers to lung diseases where scarring continues to worsen over time, often after an underlying cause such as autoimmune disease or environmental exposure.
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AP01 is being evaluated in MIST, a global Phase IIb trial in patients with PPF. The 52-week study is testing two doses of AP01 and is designed to assess safety and efficacy, including changes in forced vital capacity (FVC), a standard measure of how much air a person can exhale after taking a deep breath. Avalyn expects the main results from MIST in the second half of 2027.
Earlier AP01 data helped support the company’s move into the larger mid-stage study. In its ATLAS Phase Ib trial and open-label extension, Avalyn reported that AP01 appeared generally well tolerated, with early signs that lung function was holding steady. These findings remain preliminary, but they help explain why the company is prioritizing inhaled pirfenidone in PPF.
Avalyn’s second program, AP02, is an inhaled version of nintedanib being developed for idiopathic pulmonary fibrosis (IPF), a form of pulmonary fibrosis with no known cause. AP02 is being studied in AURA, a Phase II trial that began dosing patients in early 2026, with main results expected in late 2027.
A third program, AP03, combines inhaled pirfenidone and inhaled nintedanib in one treatment. The idea is similar to combination inhalers used in other chronic lung diseases, where more than one treatment mechanism is delivered through a single approach. Avalyn plans to start a Phase I trial of AP03 by the end of 2026.
Related: Agomab IPO Raises $200M to Fund Fibrosis Therapies
Pulmonary fibrosis research has seen both progress and setbacks in recent months. In 2025, the FDA approved Boehringer Ingelheim’s Jascayd (nerandomilast) for both IPF and PPF, marking the first new IPF therapy in more than a decade. United Therapeutics has also reported positive Phase III data for inhaled treprostinil in IPF. In contrast, Pliant Therapeutics discontinued development of bexotegrast in IPF after BEACON-IPF results showed the benefits did not appear to outweigh the risks at the studied doses.
The direct-to-lung approach is also showing up in other areas of respiratory medicine. Savara is developing an inhaled treatment for a rare lung disease called autoimmune pulmonary alveolar proteinosis, while Insmed is studying an inhaled antibiotic for broader use in MAC lung disease.
For Avalyn, the next major test is whether inhaled delivery can make antifibrotic treatment easier to tolerate while preserving the disease-slowing activity clinicians already know from oral medicines.
FAQs
What is the difference between IPF and PPF?
Idiopathic pulmonary fibrosis (IPF) is a form of lung scarring with no known cause. Progressive pulmonary fibrosis (PPF) refers to lung scarring that keeps worsening over time and can develop from other lung diseases, autoimmune conditions or environmental exposures.
Are Avalyn Pharma’s inhaled treatments approved?
No. Avalyn’s programs are still being tested in clinical trials. AP01 and AP02 are in Phase II studies, while AP03 is expected to enter Phase I testing.
Why do pulmonary fibrosis trials measure forced vital capacity?
Forced vital capacity (FVC) measures how much air a person can exhale after taking a deep breath. In pulmonary fibrosis, a drop in FVC can show that lung function is getting worse.
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