avalyn-plans-ipo-to-fund-phase-3-trials-of-inhaled-versions-of-approved-respiratory-drugs
Avalyn plans IPO to fund phase 3 trials of inhaled versions of approved respiratory drugs

Avalyn plans IPO to fund phase 3 trials of inhaled versions of approved respiratory drugs

Avalyn Pharma is eyeing an IPO as the biotech seeks more funds to take its inhaled versions of approved drugs for lung conditions into phase 3 trials.

The Cambridge, Massachusetts-based biotech has yet to disclose how many shares it is hoping to offer or at what price. But top of the list of spending priorities for the proceeds would be taking its lead drug AP01 through an ongoing phase 2b study in progressive pulmonary fibrosis and onto phase 3, according to an April 8 Securities and Exchange Commission filing.

AP01 is an inhaled formulation of pirfenidone, which is sold under many names as a pill for idiopathic pulmonary fibrosis (IPF), such as Pirespa.

The company also wants to bankroll an ongoing phase 2 study of AP02, an inhaled version of the IPF drug nintedanib, which is marketed as Ofev and Vargatef in its oral form. Avalyn is keen to take AP02 into phase 3 as well.

The final asset in Avalyn’s portfolio is AP03, an inhaled combination of pirfenidone and nintedanib that the biotech is hoping to move into the clinic. To date, pairing the oral therapies hasn’t been possible because of the additive side effects, but Avalyn is currently running preclinical studies for the asset.  

Avalyn hasn’t had trouble attracting funds in the past. The biotech secured an $100 million series D round in July 2025 that was backed by the likes of Novo Holdings. That raise followed a $175 million series C in 2023 and a $35.5 million series B back in 2020.

Having already launched mid-stage trials, the company entered 2026 with $138 million still in the bank, according to the filing.

The biotech currently employs 51 full-time employees, of which 32 work in R&D, according to yesterday’s filing. The company is headed up by CEO Lyn Baranowski, whose previous roles included developing respiratory medicines at Peal Therapeutics that would later be acquired by AstraZeneca and marketed as Breztri and Bevespi.

Biotech IPOs rebounded in the first couple of months of 2026, although listings petered out again in March.  The initial crop of offerings included other companies working on new formulations of approved drugs.

SpyGlass Pharma, which secured a $150 million IPO in February, is developing long-acting versions of approved medicines for chronic eye conditions. Meanwhile Veradermics, which made a splash with a $256.3 million debut on the New York Stock Exchange, is working on an oral version of the molecule behind hair loss treatment Rogaine.