EMA approves Moleculin's application for Phase IIb/III AML trial [Yahoo! Finance]
Moleculin Biotech, Inc. (MBRX)
Last moleculin biotech, inc. earnings: 8/16 05:35 pm
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Source: Yahoo! Finance
trial of Annamycin plus cytarabine (Ara-C) for adults with acute myeloid leukaemia (AML). The randomised, placebo-controlled, double-blind trial is intended for AML individuals who are refractory to or relapsed post-induction therapy (r/r AML). Moleculin noted that the trial, a global study including sites in Europe, the Middle East, and the US, has been approved in all nine European Union (EU) nations where it was submitted. This trial will combine data from the Phase IIb portion with the Phase III portion to measure its primary efficacy endpoint. The trial's adaptive design will see the first 75 to 90 participants randomised in Part A to obtain high-dose cytarabine (HiDAC) with either a placebo or one of two doses, 190mg/m² or 230mg/m² of Annamycin, as per the US Food and Drug Administration's (FDA) recommendation. According to the trial protocol, the preliminary efficacy and safety data will be unblinded after 45 subjects have been treated, with the first early unblinding e
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News
- Moleculin Announces Positive Results from Phase 1 Clinical Trial Evaluating WP1066 for the Treatment of Pediatric Recurrent Malignant Brain TumorsGlobeNewswire
- Moleculin Biotech (NASDAQ:MBRX) had its "buy" rating reaffirmed by analysts at Roth Capital.MarketBeat
- Moleculin Biotech (NASDAQ:MBRX) had its "buy" rating reaffirmed by analysts at HC Wainwright.MarketBeat
- Moleculin Announces Exercise of Warrants for $6.8 Million Gross ProceedsGlobeNewswire
- Moleculin Announces Completion of Treatment for the 45 Patients in Pivotal “MIRACLE” Phase 3 AML Trial on Pace for Q1 2026GlobeNewswire
MBRX
Sec Filings
- 12/23/25 - Form S-3
- 12/23/25 - Form 424B5
- 12/22/25 - Form PRER14A
- MBRX's page on the SEC website