Moleculin Accelerates Outlook Into 2026 With First Pivotal Trial Unblinding on Track, Global Trial Expansion, and Multiple Externally/IIT Funded Clinical Programs
First MIRACLE trial unblinding for 45-90 subjects expected in Q1 2026, with second unblinding in Q3 2026123
MIRACLE trial expanded globally to 9 countries and over 46 sites123
Part B of MIRACLE trial to start in 2H 2026 with 222 subjects, primary efficacy data in 2028, and rolling NDA to begin in 2028123
Investigator-initiated trials:
Atlantic Health pancreatic cancer trial begins 2H 2026; WP1066 Phase 2 GBM at Northwestern continues Q1 2026; Emory pediatric brain tumor trial starts 2H 2026123
Positive prior results from Emory Phase 1 oral WP1066 trial published, with plans for follow-on studies13
Annamycin development de-risked post Phase 1B/2 study for AML treatment12
Sources:
1. https://www.biospace.com/press-releases/moleculin-accelerates-outlook-into-2026-with-first-pivotal-trial-unblinding-on-track-global-trial-expansion-and-multiple-externally-iit-funded-clinical-programs
2. https://www.stocktitan.net/news/MBRX/moleculin-accelerates-outlook-into-2026-with-first-pivotal-trial-plr6agf3sqik.html
3. https://moleculin.com/moleculin-accelerates-outlook-into-2026-with-first-pivotal-trial-unblinding-on-track-global-trial-expansion-and-multiple-externally-iit-funded-clinical-programs/