This is a de-risking event for the AP01 program—enrollment risk is removed. However, the stock remains a binary catalyst play on Phase 2b data in H2 2027. Monitor for any safety signals or interim updates. The market cap of $1.2B suggests high expectations already priced in.
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Executive Summary
Avalyn Pharma announced it has completed target enrollment of 375 patients in the Phase 2b MIST trial of AP01 (inhaled pirfenidone) for progressive pulmonary fibrosis, ahead of schedule. Topline 12-month results are expected in the second half of 2027. This operational milestone removes enrollment risk but does not provide efficacy data; the stock remains binary on eventual readout.
Key Facts
- Target enrollment of 375 patients completed in Phase 2b MIST trial of AP01 for progressive pulmonary fibrosis
- Trial is randomized, double-blinded, placebo-controlled with 2:1:2 randomization (AP01 100mg BID, AP01 50mg BID, placebo)
- Primary endpoint: change from baseline in FVC at 52 weeks
- Topline 12-month clinical results expected in second half of 2027
- Enrollment completed ahead of schedule due to investigator and patient enthusiasm
- Additional patients currently in screening may still be enrolled
Financial Impact
No financial data provided in the filing. The company is pre-revenue clinical-stage; no revenue, earnings, or cash runway disclosed.
Risk Factors
- Phase 2b data could fail to show statistically significant improvement in FVC at 52 weeks
- Long timeline to data (H2 2027) leaves stock exposed to macro and sector sentiment
- Competition from approved oral therapies (pirfenidone, nintedanib) and other inhaled candidates
Market Snapshot
Documents Analyzed
This report is based on 5 SEC documents filed with EDGAR.
| Document | Accession Number |
|---|---|
| 8-K Filing (Primary) | 0001193125-26-273405 |
| Document: ck0001540171-ex99_1.htm | 0001193125-26-273405 |
| Document: 0001193125-26-273405-index-headers.html | 0001193125-26-273405 |
| Document: 0001193125-26-273405-index.html | 0001193125-26-273405 |
| Document: 0001193125-26-273405.txt | 0001193125-26-273405 |
Filters
| Type | Now | ||||
|---|---|---|---|---|---|
Sep 21, 2026 5w ago | Press Release | $31.62 $28.32 | ▼ −10.44% | ▼ −9.42% | $27.14 (−14.17%) |
Aug 16, 2026 10w ago | Institutional Cluster | $38.25 $37.69 | ▼ −1.46% | ▼ −0.27% | $27.14 (−29.05%) |
Aug 12, 2026 10w ago | 8-K | $37.38 $38.97 | ▲ +4.25% | ▲ +4.70% | $27.14 (−27.39%) |
Aug 12, 2026 10w ago | Press Release | $37.38 $38.97 | ▲ +4.25% | ▲ +4.70% | $27.14 (−27.39%) |
Jun 17, 2026 18w ago | 8-K | $29.31 $30.09 | ▲ +2.66% | ▲ +3.70% | $27.14 (−7.40%) |
Jun 17, 2026 18w ago | Press Release | $29.31 $30.09 | ▲ +2.66% | ▲ +3.70% | $27.14 (−7.40%) |
Jun 3, 2026 20w ago | 8-K | $26.40 $28.53 | ▲ +8.07% | ▲ +11.89% | $27.14 (+2.80%) |
May 5, 2026 24w ago | Press Release | $27.71 $29.90 | ▲ +7.90% | ▲ +6.77% | $27.14 (−2.06%) |
May 1, 2026 25w ago | Insider Cluster | $29.07 $29.57 | ▲ +1.72% | ▼ −1.25% | $27.14 (−6.64%) |
May 1, 2026 25w ago | Insider Cluster | $29.07 $29.57 | ▲ +1.72% | ▼ −1.25% | $27.14 (−6.64%) |
US Market Status
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