DYN Dyne Therapeutics, Inc.
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.
Actionable Insight
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.
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
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 | ||||
|---|---|---|---|---|---|
|
Jun 12, 2026
2d ago
|
Institutional Cluster
| $17.96 awaiting T+1 | awaiting T+1 | — | $18.19 (+1.28%) |
|
Jun 3, 2026
11d ago
|
8-K
| $17.99 $18.41 | ▲ +2.33% | ▲ +1.94% | $18.19 (+1.11%) |
|
Jun 3, 2026
11d ago
|
Press Release
| $17.99 $18.41 | ▲ +2.33% | ▲ +1.94% | $18.19 (+1.11%) |
|
May 20, 2026
25d ago
|
Press Release
| $17.37 $17.37 | · 0.00% | ▼ −0.45% | $18.19 (+4.72%) |
|
May 20, 2026
25d ago
|
Press Release
| $17.56 $17.37 | ▼ −1.08% | ▼ −1.28% | $18.19 (+3.59%) |
|
May 13, 2026
4w ago
|
144
| $18.28 $17.29 | ▼ −5.42% | ▼ −4.19% | $18.19 (−0.49%) |
|
May 13, 2026
4w ago
|
144
| $18.28 $17.29 | ▼ −5.42% | ▼ −4.19% | $18.19 (−0.49%) |
|
May 11, 2026
4w ago
|
8-K
| $18.46 $18.37 | ▼ −0.49% | ▼ −0.35% | $18.19 (−1.46%) |
|
May 6, 2026
5w ago
|
144
| $17.54 $17.61 | ▲ +0.40% | ▼ −0.43% | $18.19 (+3.71%) |
|
May 6, 2026
5w ago
|
144
| $17.54 $17.61 | ▲ +0.40% | ▼ −0.43% | $18.19 (+3.71%) |
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.
Try SecBot Free Coming soon: SecBot Pro with alerts, watchlists, and API access