What Avalyn Pharma does

Avalyn Pharma is a clinical-stage biopharmaceutical company developing inhaled therapies for rare respiratory diseases, with a primary focus on idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF), which together affect approximately 300,000 patients per year in the US and represent a global market projected to grow from roughly $3B (IPF alone) to $7B by 2035. The company's core technology is an inhaled aerosol drug-delivery platform that reformulates two validated, commercially successful anti-fibrotic small molecules — pirfenidone (marketed as Esbriet) and nintedanib (marketed as Ofev) — into aerosolized soft-mist formulations administered via the approved PARI eFlow handheld nebulizer. The lead candidate AP01 is inhaled pirfenidone (currently in a 375-patient Phase 2b MIST trial for PPF), AP02 is inhaled nintedanib (currently in the 160-patient Phase 2 AURA trial for IPF), and AP03 is a preclinical fixed-dose inhaled combination of both drugs that is not feasible orally due to additive systemic side effects.

The strategic rationale is to deliver higher lung drug concentrations than oral therapy while keeping systemic exposure well below oral levels, thereby reducing the GI, hepatic, and photosensitivity side effects that drive dose reductions and discontinuation with the oral drugs. Avalyn has built long-term safety data on inhaled pirfenidone through the ATLAS Phase 1b study and open-label extension, now extending past 240+ weeks (4+ years), and has assembled an 18-investor syndicate led by Suvretta Capital Management, SR One, Catalio Capital, and Novo Holdings, with a $100M Series D in July 2025 and a $345M Nasdaq IPO in April–May 2026 at an implied ~$1.1B market capitalization.

The business model is pre-revenue: Avalyn generates no product revenue today, reported a net loss of $85.2M in 2025, and is investing IPO proceeds in late-stage clinical development and pre-commercial buildout. Future revenue, contingent on regulatory approval, is expected to follow a specialty-pharma / orphan-drug pricing model for rare lung disease therapeutics, distributed through a planned direct specialty sales force targeting pulmonologists, ILD centers, and specialty pharmacies, supported by an 17+ patient and medical-organization partnership network and two Patient Advisory Councils.

Name

Avalyn Pharma

Legal name

Avalyn Pharma Inc.

Website

https://avalynpharma.com

Company type

Public

Founded year

2011

Operating status

Ipo

Headcount range

11–50 employees

Short description

Avalyn Pharma is a clinical-stage biopharma developing inhaled reformulations of pirfenidone and nintedanib for patients with idiopathic and progressive pulmonary fibrosis, delivered via nebulizer. The company is publicly traded on Nasdaq (AVLN) and pre-revenue, with three programs in Phase 2b, Phase 2, and preclinical development.

Ownership category

akta.pro rank

Product category

Inhaled Pulmonary Fibrosis Therapeutics

NAICS

Pharmaceutical and Medicine Manufacturing (3254)

SIC

Pharmaceutical Preparations (2834)

akta.pro primary industry

Pulmonary Hypertension & Rare Pulmonary Disease Therapies (HLAIAIAG)

Keywords

• Inhaled therapeutics
• Pulmonary fibrosis treatment
• Clinical-stage biopharma
• Aerosol drug delivery
• Interstitial lung disease

Headquarters

HQ city

Seattle

HQ country

United States

HQ region

North America

Offices3 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Personnel, Operations, Others, Marketing or Sales, Infrastructure

Revenue model

1. Pre-revenue clinical-stage development: Avalyn is a clinical-stage biopharmaceutical company with no approved products; it currently generates no product revenue. Future revenue is expected to come from commercialization of its inhaled therapeutic candidates (AP01, AP02, AP03) in rare respiratory diseases once regulatory approval is obtained.

Go-to-market motion4 records

Distribution channels3 records

Marketing channels8 records

Core offering

Avalyn Pharma is a clinical-stage biopharmaceutical company developing inhaled reformulations of two validated anti-fibrotic drugs — pirfenidone (AP01) and nintedanib (AP02) — plus a preclinical fixed-dose inhaled combination of the two (AP03), for delivery via the approved PARI eFlow handheld nebulizer to treat idiopathic pulmonary fibrosis (IPF), progressive pulmonary fibrosis (PPF), and other interstitial lung diseases. Its lead candidates aim to achieve higher lung drug exposure with significantly lower systemic toxicity than the corresponding oral therapies, and the company has no approved or commercialized products as of the IPO in May 2026.

Differentiator

Problem solved

Functional benefit

Products and services

• AP01 (Inhaled Pirfenidone) AP01 is Avalyn's lead clinical-stage program: an aerosolized soft-mist formulation of pirfenidone delivered via the approved PARI eFlow handheld nebulizer. It is being developed for idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF), with the goal of achieving higher anti-fibrotic drug exposure in diseased lung tissue while minimizing the systemic side effects (GI, hepatic, photosensitivity) that limit oral pirfenidone (Esbriet).
• AP02 (Inhaled Nintedanib) AP02 is Avalyn's second clinical-stage program: an aerosolized soft-mist formulation of nintedanib (a tyrosine kinase inhibitor) delivered via the approved PARI eFlow handheld nebulizer for direct lung delivery. It is being developed for IPF, with the goal of avoiding the systemic toxicities (diarrhea, hyperbilirubinemia, liver injury) associated with oral nintedanib (Ofev) while maintaining anti-fibrotic effect in diseased lung tissue.
• AP03 (Inhaled Pirfenidone + Nintedanib Fixed-Dose Combination) AP03 is Avalyn's preclinical-stage program: a fixed-dose combination of pirfenidone and nintedanib delivered as an inhaled aerosol via the PARI eFlow nebulizer. It is designed to enable combination anti-fibrotic therapy that has not been feasible orally because of additive systemic side effects of the two drugs, while still delivering the combination directly to the lung.

Quantifiable outcome

• 100 mg BID dose of inhaled pirfenidone (AP01) achieved near-stabilization of lung function over 48 weeks of treatment in the Phase 1b ATLAS study (West et al., 2023).
• +4 more outcomes

Segments4 records

Ideal customer profiles4 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature5 records

Partnerships

20 partnerships are on record, tiered core, major and minor.

• Pulmonary Fibrosis Foundation (PFF)coreGTM or Marketing PartnerPatient/medical organization partner for education and program support for the PF community; relevant to Avalyn's primary indication and patient advocacy work.
• American Thoracic Society (ATS)coreGTM or Marketing PartnerProfessional medical society partner; multiple Avalyn posters and presentations featured at ATS International Conference on AP01, AP02, devices, and patient journey work.
• American Lung Association (ALA)majorGTM or Marketing PartnerPatient/medical organization partner supporting education and programs for patients, families, and care partners affected by pulmonary fibrosis and other lung diseases.
• European Respiratory Society (ERS)majorGTM or Marketing PartnerMedical society partner; Avalyn has presented multiple AP01 and AP02 posters and study-design updates at the ERS International Congress.
• The European Pulmonary Fibrosis Federation (EU-PFF)majorGTM or Marketing PartnerEuropean patient-federation partner for PF community education and advocacy across Europe.
• Canadian Pulmonary Fibrosis Foundation (CPFF)majorGTM or Marketing PartnerCanadian patient-foundation partner for PF patient education and support programs.
• Action for Pulmonary FibrosismajorGTM or Marketing PartnerUK-based PF patient organization partner supporting the patient community.
• American College of CHEST Physicians (CHEST)majorGTM or Marketing PartnerUS professional medical society partner for clinician education and PF resources.
• Canadian Thoracic SocietyminorGTM or Marketing PartnerCanadian respiratory society partner for clinician engagement and educational resources.
• Lung Foundation AustraliaminorGTM or Marketing PartnerAustralian patient/medical organization partner for lung-disease education and community support.
• Foundation for Sarcoidosis ResearchminorGTM or Marketing PartnerPatient-organization partner for sarcoidosis awareness and education, relevant to ILD indications Avalyn's pipeline addresses.
• The Myositis AssociationminorGTM or Marketing PartnerPatient-organization partner for myositis-ILD education; relevant to PPF and connective-tissue disease-associated ILD populations.
• National Scleroderma FoundationminorGTM or Marketing PartnerPatient-organization partner for scleroderma-ILD community; relevant to connective-tissue disease-associated PPF populations.
• PF WarriorsminorGTM or Marketing PartnerPatient-advocacy partner serving the pulmonary fibrosis community.
• Rheumatology Research FoundationminorGTM or Marketing PartnerMedical research foundation partner relevant to rheumatology-associated ILD populations.
• Vasculitis FoundationminorGTM or Marketing PartnerPatient-organization partner for vasculitis-ILD community support and education.
• Wescoe Foundation for Pulmonary FibrosisminorGTM or Marketing PartnerPatient-advocacy partner for the PF community, based in Pennsylvania.
• PARI (eFlow® nebulizer system)coreTechnology or IntegrationAvalyn's lead clinical programs (AP01 and AP02) are delivered via the approved PARI eFlow® handheld nebulizer system. PARI is referenced in the clinical-trial descriptions for the MIST and AP02 Phase 1b studies as the device partner for inhaled delivery.
• IPAC: Idiopathic Pulmonary Fibrosis Patient Advisory CouncilcoreStrategic or Co-development PartnerOne of two Avalyn Patient Advisory Councils (along with PPAC). The IPAC integrates patient and care-partner insights into study design, medicine development, and trial participation for IPF.
• PPAC: Progressive Pulmonary Fibrosis Patient Advisory CouncilcoreStrategic or Co-development PartnerOne of two Avalyn Patient Advisory Councils. The PPAC integrates patient and care-partner insights into study design, medicine development, and trial participation for PPF.

Scale indicators16 records

Recent moves7 records

Expansion highlights6 records

Direct peers

• Pliant Therapeutics: Clinical-stage biopharma developing novel therapies for IPF and other fibrotic diseases (lead asset bexotegrast). Comparable because it targets the same primary indication (IPF/PPF) and competes for the same pulmonologist/ILD-center patient population as Avalyn's AP01 and AP02.
• Verona Pharma: Late-stage respiratory therapeutics company developing ensifentrine for COPD and other lung diseases. Comparable as a clinical-stage respiratory company pursuing FDA approval of a differentiated inhaled therapy for serious chronic lung disease, with similar regulatory and commercialization trajectory.
• FibroGen: Biopharmaceutical company that has developed therapeutics targeting fibrotic diseases including IPF (historical pamrevlumab program). Comparable as a clinical-stage company targeting IPF/ILD with novel mechanisms and competing for the same pulmonologist/ILD-center prescriber base.

Broad incumbents

• United Therapeutics: Established rare-disease pulmonary company with Tyvaso DPI (inhaled treprostinil) approved for PAH and PH-ILD. Comparable as a broad incumbent in inhaled/respiratory therapeutics for fibrotic lung disease with a commercial specialty-pharma infrastructure that Avalyn aspires to build.
• Boehringer Ingelheim: Marketer of Ofev (nintedanib), one of only two approved oral anti-fibrotic drugs for IPF and the reference molecule for Avalyn's AP02 program. Comparable as the dominant incumbent in IPF whose physician, payer, and KOL relationships Avalyn must overcome commercially.
• Genentech / Roche: Marketer of Esbriet (pirfenidone), the other approved oral anti-fibrotic drug for IPF and reference molecule for Avalyn's AP01 program. Comparable as a major biopharma incumbent whose launch infrastructure Avalyn's commercial team (led by ex-ESBRIET US launch lead) is designed to compete against.

Emerging players

• Insmed Incorporated: Late-stage inhaled-therapeutics company with commercial rare-disease respiratory assets (e.g., ARIKAYCE for MAC lung disease and the Phase 3 brensocatib program). Comparable as a company that has scaled an inhaled-therapeutics platform and a specialty-pharma commercial model for serious lung diseases — a credible template for Avalyn's evolution.
• Kinevant Sciences: Roivant-affiliated clinical-stage biopharma developing therapies for sarcoidosis and other inflammatory/ILDs. Comparable as a Roivant-platform emerging respiratory/ILD company pursuing orphan indications that overlap with Avalyn's broader ILD strategy.
• Aerami Therapeutics: Clinical-stage inhaled therapeutics company developing liposomal aerosol formulations for serious lung diseases. Comparable as an emerging inhaled-drug-delivery player; several Avalyn executives (e.g., COO Melissa Rhodes) previously led development there.

Others

• Altavant Sciences (Enzyvant): Roivant-affiliated rare respiratory/ILD company where Avalyn CEO Lyn Baranowski and other Avalyn executives previously led development. Comparable as a strategically related rare-respiratory biopharma platform and historical source of Avalyn's talent base.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/avalyn-pharma-inc

Revenue estimate

Valuation estimate

Number of profiles

Profiles18 records

Funding overview

Funding rounds4 records

Investors21 records

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Avalyn Pharma