$MBRXJul 31, 2026, 8:05 AM ETAI processed8-K
MBRX: Blinded MIRACLE interim CRc 37% overall and 37% in venetoclax-failed subgroup; Part A 74/90, full readout Dec 2026–Feb 2027
AI Summary
MBRX filed SEC Form 8-K. Enrollment is at 74 of 90 patients with the company expecting to treat the 90th subject in September 2026 and to unblind comprehensive Part A data in December 2026–February 2027; the filing also reports no evidence of cardiotoxicity and notes the analysis is blinded (includes control-arm patients) and preliminary.
Positives
- Preliminary blinded CRc of 37% (n=62) reported from Part A
- Venetoclax-failure subgroup (n=30) shows same CRc of 37%, suggesting prior venetoclax failure did not lower observed blinded remission rates
- Enrollment at 74/90 with 90th subject expected treated in Sep 2026 and full Part A unblinding targeted Dec 2026–Feb 2027
Negatives
- Data are preliminary and blinded (include control-arm subjects) with small sample sizes (62 overall, 30 in venetoclax subgroup) and the trial is not powered for subgroup comparisons
- Company discloses it will require significant additional financing and has no commitments for that financing
- MIRACLE measures remission after a single treatment cycle, which the company notes can yield lower absolute remission rates than historical multi-cycle studies