Monitor mid-2026 for Cohort 1 dystrophin data, which will be the first efficacy readout for ENTR-601-45. Positive dystrophin expression could drive significant upside for this single-asset-stage biotech; negative or ambiguous data would be highly bearish. Until then, no near-term catalyst.
Price Chart
Executive Summary
Entrada Therapeutics announced that an independent DMC recommended dose escalation to 10 mg/kg in Cohort 2 of the ELEVATE-45-201 Phase 1/2 study for ENTR-601-45 in Duchenne muscular dystrophy (exon 45). The company remains on track to report Cohort 1 safety, PK, and dystrophin data in mid-2026, with Cohort 2 and 3 data to follow. This is a routine clinical progress update with no new efficacy data released, making the near-term impact neutral.
Key Facts
- DMC recommended initiation of Cohort 2 at 10 mg/kg (up from 5 mg/kg in Cohort 1) after reviewing safety and PK data from 8 participants.
- Company on track to report Cohort 1 data (safety, early PK, dystrophin) in mid-2026.
- ELEVATE-45-201 is a Phase 1/2 MAD study of ENTR-601-45 for DMD patients amenable to exon 45 skipping.
- Dosing regimen is once every six weeks; planned doses across three cohorts range from 5 mg/kg to 15 mg/kg.
- No financial data, revenue, or earnings were disclosed in the press release.
Financial Impact
No financial figures disclosed; pre-revenue clinical-stage biotech.
Risk Factors
- Cohort 1 data (mid-2026) may show insufficient dystrophin expression or safety signals, leading to program termination.
- DMD exon 45 space is competitive (Sarepta's Casimersen already approved); differentiation on efficacy or dosing frequency is unproven.
- Pre-revenue company with limited cash runway — future dilution risk for ongoing trials.
Market Snapshot
Investment Themes
Documents Analyzed
This report is based on 1 press release from GlobeNewswire.
| Document | Accession Number |
|---|---|
| PRESS-RELEASE Data (Synthetic) | press-3304981 |
Filters
| Type | Now | ||||
|---|---|---|---|---|---|
Sep 9, 2026 22d ago | Insider Cluster | $6.42 $6.90 | ▼ −7.48% | ▼ −7.98% | $5.38 (+16.20%) |
Sep 3, 2026 29d ago | Insider Cluster | $7.17 $6.80 | ▼ −5.16% | ▼ −4.01% | $5.38 (−24.97%) |
Aug 31, 2026 4w ago | Insider Cluster | $7.07 $7.11 | ▲ +0.57% | ▲ +0.48% | $5.38 (−23.90%) |
Aug 31, 2026 4w ago | Insider Cluster | $7.07 $7.11 | ▲ +0.57% | ▲ +0.48% | $5.38 (−23.90%) |
Aug 31, 2026 4w ago | Insider Cluster | $7.07 $7.11 | ▲ +0.57% | ▲ +0.48% | $5.38 (−23.90%) |
Aug 27, 2026 5w ago | Insider Cluster | $7.27 $7.17 | ▼ −1.38% | ▼ −1.64% | $5.38 (−26.00%) |
Aug 10, 2026 7w ago | Insider Cluster | $7.04 $7.27 | ▲ +3.27% | ▲ +3.67% | $5.38 (−23.58%) |
Aug 5, 2026 8w ago | 8-K | $7.06 $7.67 | ▲ +8.64% | ▲ +8.29% | $5.38 (−23.80%) |
Aug 3, 2026 8w ago | Insider Cluster | $7.24 $7.04 | ▼ −2.76% | ▼ −2.66% | $5.38 (−25.69%) |
Jul 30, 2026 9w ago | 144 | $6.79 $6.87 | ▼ −1.18% | ▲ +2.33% | $5.38 (+20.77%) |
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