MBRX Moleculin Biotech, Inc.
Price Chart
Executive Summary
Moleculin Biotech presented a pooled analysis at ASCO 2026 showing no detectable cardiotoxicity for its lead drug Annamycin across 90 patients, with independent review by Cleveland Clinic. The data reinforces the drug's differentiated safety profile as the pivotal Phase 2b/3 MIRACLE trial advances, with unblinding of the first 45 patients on track for June 2026.
Actionable Insight
The ASCO safety data is incrementally positive but not transformative — the stock's primary catalyst remains the MIRACLE trial unblinding in June 2026. Monitor for the unblinding results, which will determine the drug's approvability path. The company's $15M market cap and need for additional financing create binary risk around the trial outcome.
Key Facts
- Pooled analysis of 90 patients across five completed trials showed no statistically significant change in LVEF (mean difference -0.12%; p=0.84)
- Median cumulative Annamycin dose was 660 mg/m², with exposures up to 2,970 mg/m² — far exceeding conventional anthracycline lifetime limits
- Independent cardiac review conducted by Cleveland Clinic Division of Cardiovascular Medicine
- Phase 1b/2 AML study demonstrated 50% CR rate, 60% CRc rate, and median OS of 12.39 months
- Unblinding from first 45 patients of the pivotal Phase 2b/3 MIRACLE trial is on track for June 2026
- Company is a Phase 3 clinical-stage biotech with a $15M market cap and will require significant additional financing
Financial Impact
No financial data in filing; clinical-stage company with no reported revenue. Key catalyst is the upcoming MIRACLE trial unblinding in June 2026.
Risk Factors
- Company requires significant additional financing with no commitments in place
- MIRACLE trial unblinding in June 2026 is the key binary catalyst — safety data alone does not de-risk efficacy
- Small dataset (90 patients) with no randomized controlled data yet
- Historical T+20 performance on prior MBRX reports shows negative average alpha (-0.94%) with only 40% win rate
Market Snapshot
Documents Analyzed
This report is based on 5 SEC documents filed with EDGAR.
| Document | Accession Number |
|---|---|
| 8-K Filing (Primary) | 0001437749-26-018819 |
| Exhibit: ex_969652.htm | 0001437749-26-018819 |
| Document: 0001437749-26-018819-index-headers.html | 0001437749-26-018819 |
| Document: 0001437749-26-018819-index.html | 0001437749-26-018819 |
| Document: 0001437749-26-018819.txt | 0001437749-26-018819 |
Filters
| Type | Now | ||||
|---|---|---|---|---|---|
|
Jun 5, 2026
today
|
8-K
| $2.55 awaiting T+5 | awaiting T+5 | — | $2.40 (−5.88%) |
|
May 29, 2026
7d ago
|
8-K
| $2.79 $2.46 | ▼ −11.83% | ▼ −11.54% | $2.40 (−13.98%) |
|
May 26, 2026
10d ago
|
8-K
| $2.45 $2.64 | ▲ +7.76% | ▲ +6.67% | $2.40 (−2.04%) |
|
May 22, 2026
14d ago
|
8-K
| $2.45 $2.64 | ▲ +7.76% | ▲ +6.67% | $2.40 (−2.04%) |
|
May 15, 2026
21d ago
|
8-K
| $2.11 $2.39 | ▲ +13.27% | ▲ +12.31% | $2.40 (+13.74%) |
|
May 15, 2026
21d ago
|
Press Release
| $2.11 $2.39 | ▼ −13.27% | ▼ −12.31% | $2.40 (−13.74%) |
|
May 13, 2026
23d ago
|
8-K
| $2.14 $2.35 | ▲ +9.81% | ▲ +10.97% | $2.40 (+12.15%) |
|
May 12, 2026
24d ago
|
8-K
| $2.34 $2.09 | ▼ −10.68% | ▼ −10.76% | $2.40 (+2.56%) |
|
May 8, 2026
28d ago
|
8-K
| $2.47 $2.20 | ▼ −10.93% | ▼ −12.39% | $2.40 (−2.83%) |
|
Apr 23, 2026
6w ago
|
8-K
| $2.54 $2.51 | ▼ −1.18% | ▼ −2.66% | $2.40 (−5.51%) |
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