No financial data or efficacy results were released — this is a progress update. Traders should monitor for topline data in H2 2027 and any early readouts from the ongoing OLE study. The stock is likely to trade on cash runway estimates and pipeline timeline updates rather than this enrollment milestone.
Price Chart
Executive Summary
Avalyn Pharma completed target enrollment (375 patients) ahead of schedule in the Phase 2b MIST trial of AP01 (inhaled pirfenidone) for progressive pulmonary fibrosis. Topline data expected in H2 2027. The event is a modest operational milestone — no efficacy or safety data released — making it neutral for stock impact.
Key Facts
- Target enrollment of 375 patients completed in Phase 2b MIST trial of AP01 for progressive pulmonary fibrosis
- Additional patients currently in screening may still be enrolled
- Trial is randomized, double-blind, placebo-controlled with 2:1:2 allocation (100mg, 50mg, placebo)
- Primary endpoint: change from baseline in FVC at 52 weeks
- Topline data expected in the second half of 2027 — ~12-18 months away
- Phase 1b ATLAS data previously showed low rates of GI and liver side effects vs oral pirfenidone
Financial Impact
Not specified
Risk Factors
- Phase 2b MIST trial may fail to show statistically significant improvement in FVC
- Clinical hold, safety signal, or enrollment delays could derail timeline
- Avalyn is pre-revenue and will require additional financing to complete the trial and advance pipeline
- Competing therapies for PPF/IPF may diminish AP01's commercial opportunity
Market Snapshot
Documents Analyzed
This report is based on 1 press release from GlobeNewswire.
| Document | Accession Number |
|---|---|
| PRESS-RELEASE Data (Synthetic) | press-3313361 |
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
Subscribe to SecBot
Get Real-Time SEC Filing Intelligence
Comprehensive SEC filing analysis delivered the moment filings hit EDGAR. Sentiment scoring, impact analysis, and actionable insights for every material event.
Create a free account Live analysis, Telegram alerts, watchlists and the MCP server for subscribers