The consistent blinded CRc across harder-to-treat subgroups is a positive signal, but the stock remains binary on the unblinded Part A readout. Traders should monitor enrollment completion and any early unblinding announcements; the next major catalyst is the full Part A data expected in late 2026 to early 2027.
Price Chart
Executive Summary
Moleculin reported updated preliminary blinded results from Part A of its pivotal MIRACLE trial for Annamycin in R/R AML, showing a 37% composite complete remission (CRc) rate among 62 evaluable subjects, including a 37% CRc in the 48% of patients who had failed prior venetoclax therapy. The blinded CRc has remained in a narrow 37-40% band across three analyses while the population became harder to treat, and enrollment is at 74 of 90 subjects with unblinded results expected in the December 2026–February 2027 timeframe. The data is encouraging but still blinded and includes control-arm subjects, so the definitive catalyst remains months away.
Key Facts
- Preliminary blinded CRc of 37% (n=62) in R/R AML, with CR of 24%
- Among 30 patients (48%) who failed prior venetoclax, CRc was also 37% (3x published salvage rate of ~13%)
- Enrollment at 74 of 90 subjects; final Part A treatment expected September 2026
- Unblinded comprehensive Part A results on track for December 2026–February 2027
- No evidence of cardiotoxicity observed
Financial Impact
Positive clinical data supports regulatory pathway and potential partnering; no financial figures reported
Risk Factors
- Data is still blinded and includes control-arm subjects; final unblinded results may differ
- Company requires significant additional financing with no commitments (per forward-looking statements)
- Micro-cap stock with high volatility and binary trial risk
Market Snapshot
Investment Themes
Documents Analyzed
This report is based on 5 SEC documents filed with EDGAR.
| Document | Accession Number |
|---|---|
| 8-K Filing (Primary) | 0001437749-26-025167 |
| Exhibit: ex_995334.htm | 0001437749-26-025167 |
| Document: 0001437749-26-025167-index-headers.html | 0001437749-26-025167 |
| Document: 0001437749-26-025167-index.html | 0001437749-26-025167 |
| Document: 0001437749-26-025167.txt | 0001437749-26-025167 |
Filters
| Type | Now | ||||
|---|---|---|---|---|---|
Oct 20, 2026 6d ago | 8-K | $6.19 | awaiting T+20 | — | $7.09 (+14.46%) |
Oct 16, 2026 10d ago | 8-K | $0.2804 | awaiting T+20 | — | $7.09 (+2426.75%) |
Oct 9, 2026 17d ago | 8-K | $0.4139 | awaiting T+20 | — | $7.09 (+1611.77%) |
Oct 5, 2026 21d ago | 8-K | $0.4766 | awaiting T+20 | — | $7.09 (+1386.57%) |
Sep 29, 2026 27d ago | 8-K | $0.5264 | awaiting T+20 | — | $7.09 (+1245.93%) |
Sep 29, 2026 27d ago | Press Release | $0.5264 | awaiting T+20 | — | $7.09 (+1245.93%) |
Sep 28, 2026 28d ago | 8-K | $0.5690 $7.09 | ▲ +1145.17% | ▲ +1145.20% | $7.09 (+1145.17%) |
Sep 25, 2026 4w ago | 8-K | $0.6016 $6.50 | ▲ +980.45% | ▲ +981.93% | $7.09 (+1077.69%) |
Sep 23, 2026 4w ago | 8-K | $0.5279 $6.31 | ▲ +1095.30% | ▲ +1094.61% | $7.09 (+1242.11%) |
Sep 18, 2026 5w ago | 8-K | $0.5202 | awaiting T+20 | — | $7.09 (−1261.98%) |
US Market Status
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