The stock will trade on pipeline execution milestones: the BLA submission for z-rostudirsen (expected Q2 2026) and the DM1 data readout (Q1 2027). Cash runway into Q1 2028 removes near-term financing risk. Monitor for any delays in the BLA submission or changes in FDA feedback.
Price Chart
Executive Summary
Dyne Therapeutics reported Q1 2026 net loss of $120.9M ($0.73/share), wider than the $115.4M loss in Q1 2025 but narrower on a per-share basis due to a higher share count. The key catalyst is the completed positive pre-BLA meeting with the FDA for z-rostudirsen in DMD, keeping the BLA submission on track for Q2 2026 and a potential launch in Q1 2027. Enrollment in the ACHIEVE trial for DM1 has reached its 60-participant target, with data expected in Q1 2027.
Key Financial Metrics
Key Facts
- Net loss of $120.9M for Q1 2026 vs $115.4M in Q1 2025
- EPS of -$0.73 vs -$1.05 in Q1 2025 (narrower loss per share due to share count increase)
- Cash, cash equivalents and marketable securities of $972.2M as of March 31, 2026
- Cash runway expected into Q1 2028
- Positive pre-BLA meeting completed with FDA for z-rostudirsen; BLA submission on track for Q2 2026
- Potential U.S. launch of z-rostudirsen expected in Q1 2027
- Enrollment target of 60 participants reached in ACHIEVE REC for z-basivarsen in DM1
- Global confirmatory Phase 3 HARMONIA trial for z-basivarsen initiated in March 2026
Financial Impact
Net loss increased by $5.5M YoY; R&D spend decreased slightly to $100.9M from $106.4M; G&A spend increased to $24.4M from $15.9M due to launch preparation costs
Risk Factors
- Regulatory risk: FDA may not grant Accelerated Approval or Priority Review for z-rostudirsen
- Clinical risk: DM1 data from ACHIEVE trial in Q1 2027 may not support BLA submission
- Competitive risk: other DMD and DM1 therapies in development
- Dilution risk: net loss continues to widen, potentially requiring future capital raises
Market Snapshot
Investment Themes
Documents Analyzed
This report is based on 6 SEC documents filed with EDGAR.
| Document | Accession Number |
|---|---|
| 8-K Filing (Primary) | 0001193125-26-215720 |
| Document: dyn-20260511.htm | 0001193125-26-215720 |
| Document: 0001193125-26-215720-index-headers.html | 0001193125-26-215720 |
| Document: 0001193125-26-215720-index.html | 0001193125-26-215720 |
| Document: 0001193125-26-215720.txt | 0001193125-26-215720 |
| 8-K Data (Synthetic) | 0001193125-26-215720 |
Filters
| Type | Now | ||||
|---|---|---|---|---|---|
Aug 17, 2026 6w ago | Insider Cluster | $26.15 $17.90 | ▲ +31.55% | ▲ +29.57% | $15.20 (+41.87%) |
Aug 14, 2026 6w ago | 144 | $26.15 $18.52 | ▼ −29.18% | ▼ −27.65% | $15.20 (−41.87%) |
Aug 13, 2026 7w ago | 144 | $25.70 $18.52 | ▲ +27.94% | ▲ +25.95% | $15.20 (+40.86%) |
Aug 13, 2026 7w ago | 144 | $25.70 $18.52 | ▼ −27.94% | ▼ −25.95% | $15.20 (−40.86%) |
Aug 13, 2026 7w ago | 144 | $25.70 $18.52 | ▼ −27.94% | ▼ −25.95% | $15.20 (−40.86%) |
Jul 29, 2026 9w ago | Press Release | $25.73 $26.09 | ▲ +1.40% | ▼ −2.57% | $15.20 (−40.92%) |
Jul 22, 2026 10w ago | Press Release | $23.21 $26.78 | ▼ −15.38% | ▼ −12.48% | $15.20 (+34.51%) |
Jul 20, 2026 10w ago | 8-K | $23.45 $26.15 | ▲ +11.51% | ▲ +7.39% | $15.20 (−35.18%) |
Jun 30, 2026 13w ago | Insider Cluster | $21.79 $25.10 | ▲ +15.19% | ▲ +17.38% | $15.20 (−30.24%) |
Jun 29, 2026 13w ago | 144 | $22.21 $25.63 | ▼ −15.40% | ▼ −16.43% | $15.20 (+31.56%) |
US Market Status
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