Avalyn Pharma (AVLN)
Develops inhaled pirfenidone and nintedanib candidates for pulmonary fibrosis.
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Reformulates established antifibrotic medicines into nebulized, lung-targeted candidates for pulmonary fibrosis, with AP01 and AP02 as the core programs. Its drug-device model depends on PARI nebulizer rights and an FDA pathway intended to bridge to prior findings on the oral medicines.
Develops inhaled, lung-targeted versions of established antifibrotic medicines for pulmonary fibrosis. AP01 is optimized inhaled pirfenidone for progressive pulmonary fibrosis, while AP02 is optimized inhaled nintedanib for idiopathic pulmonary fibrosis. AP03 combines both medicines in a preclinical inhaled fixed-dose candidate.
Operates as a clinical-stage drug-device developer, pairing formulations with PARI eFlow/eRapid nebulizer technology. Direct lung delivery is intended to increase local exposure while reducing systemic exposure associated with tolerability problems in oral therapies. The regulatory approach depends on the FDA permitting a bridge to prior findings for the oral medicines, while development relies on CROs, clinical sites, contract manufacturers, device suppliers, and licensed PARI rights.
Company facts
Unavailable right now.
EPSReportedEstimate
RevenueReportedEstimate
Balance sheet, Jun 30, 2026Cash & short-term investments $352.4M · Total debt $17.1M · Total assets $425.4M · Shareholders' equity $398.3M
- Revenue
- $0
- Operating income
- −$31.3M
- Net income
- −$28.9M
No dividends on record.
| Institutions94 holders · as of Jun 30, 2026 | 99.61% | 44.16M shares | |
| Otherremainder | 0.39% | 171.5K shares |
44.33M company shares as of Aug 22, 2026 · institutions as of Jun 30, 2026 · holders as of their latest filing
The share count has not been confirmed by a second filing; stakes use it as it stands.
Top shareholders13F · 13D/G · Form 4
| Holder | Stake | Shares | Evidence |
|---|---|---|---|
FMR LLCInstitution | 13.16% | 5.84M | 13Fas of Jun 30, 2026 |
Novo Holdings A/SInstitution | 8.76% | 3.88M | 13Fas of Jun 30, 2026 |
Sr One Capital Management, LPInstitution | 7.46% | 3.31M | 13Fas of Jun 30, 2026 |
Perceptive Advisors LLCInstitution | 6.03% | 2.68M | 13Fas of Jun 30, 2026 |
Suvretta Capital Management, LLCInstitution | 5.65% | 2.50M | 13Fas of Jun 30, 2026 |
| See all 25 → | |||
13F — a manager's quarterly holdings
Insider tradesForm 4
Nothing filed in the last 12 months.
- United Therapeutics
Advanced inhaled antifibrotic rival across IPF and PPF.
- MannKind
Closest rival in inhaled nintedanib for IPF and PPF.
- Contineum Therapeutics
Phase 2 oral LPA1 program for the IPF patient pool.
Compare
| Company | Price | Change | |||||
|---|---|---|---|---|---|---|---|
| Avalyn Pharma | $35.47 | +0.54% | $1.58B | — | — | — | — |
| United Therapeutics | $492.02 | +0.01% | $20.88B | 17.6 | 18.9 | 6.6 | −1.9% |
| MannKind | $3.99 | −1.12% | $1.29B | — | — | 3.3 | +42.9% |
| Contineum Therapeutics | $17.24 | +4.14% | $648.6M | — | — | — | — |
| Median | 17.6 | 18.9 | 4.9 | +20.5% |