Pulmonary fibrosis drug developer Avalyn files IPO
Avalyn's inhaled therapies use a nebuliser technology developed by PARI.
Boston-based biotech Avalyn Pharma is the latest to hop on the IPO train, filing to list on the Nasdaq and raise funds for late-stage clinical development of its inhaled therapies for pulmonary fibrosis (PF).
According to the prospectus filed with the Securities and Exchange Commission (SEC), which has a placeholder value of $100 million, Avalyn is planning to list on the Nasdaq under the AVLN symbol.
Its approach is to develop improved inhaled versions of two FDA-approved oral kinase inhibitor therapies for PF, Boehringer Ingelheim's Ofev (nintedanib) and Roche's Esbriet (pirfenidone), which have dominated the treatment of the disease for many years with blockbuster sales.
In 2025, Boehringer also got US approval for a third therapy with a different mechanism, PDE4B inhibitor Jascayd (nerandomilast), that it hopes will succeed Ofev when the drug loses patent protection around the end of this decade.
Avalyn's lead candidates AP01 and AP02, are inhaled formulations of pirfenidone and nintedanib, respectively, and are in mid-stage clinical testing. The company thinks that localised delivery to the lungs will avoid some of the systemic side effects of the two drugs and – potentially – could improve efficacy so they stop PF progression altogether, rather than slowing it down.
PF is a life-threatening disorder, characterised by scarring of lung tissue that affects lung function, and has a median survival of just three to five years, making it more deadly than many kinds of cancer.
AP01 has completed a phase 1b trial (ATLAS) in idiopathic pulmonary fibrosis (IPF) and has started an open-label extension in progressive pulmonary fibrosis (PPF), another form of the disease, as well as a phase 2b PPF trial called MIST.
AP02, meanwhile, has also cleared phase 1 testing and is in the phase 2 AURA trial in IPF, while a dual inhaled therapy based on both active compounds (AP03) is being prepared for initial human testing later this year. All three drug candidates are based on a respiratory delivery technology licensed from PARI that is already used in commercial products.
Ofev and Esbriet are approved to treat IPF, which has no obvious cause and affects around 120,000 people in the US. Jascayd has been cleared for both IPF and PPF – generally caused by a known factor such as autoimmune disease or exposure to allergens – which is a little more common, with approximately 180,000 cases.
Avalyn's last financing was a $100 million Series D, which closed in July 2025, taking the total to almost $390 million since the company was founded in 2011.
